Diquafosol ophthalmic solution 3 %: a review of its use in dry eye.

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Keating, Gillian M

2015-05-01

Diquafosol ophthalmic solution 3 % (Diquas(®)) is a P2Y2 receptor agonist that promotes tear fluid and mucin secretion and is currently approved in Japan and South Korea for the treatment of dry eye. In randomized, double-blind, multicentre trials in patients with dry eye, significantly greater improvements in fluorescein and rose bengal staining scores were seen with diquafosol ophthalmic solution 3 % than with placebo, and diquafosol ophthalmic solution 3 % was noninferior to sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the fluorescein staining score and more effective than sodium hyaluronate ophthalmic solution 0.1 % in terms of the improvement in the rose bengal staining score. The efficacy of diquafosol ophthalmic solution 3 % in the treatment of dry eye was maintained in the longer term, with improvements also seen in subjective dry eye symptoms, and was also shown in a real-world setting. Diquafosol ophthalmic solution 3 % also demonstrated efficacy in various specific dry eye disorders, including aqueous-deficient dry eye, short tear film break-up time dry eye, obstructive meibomian gland dysfunction, dry eye following laser in situ keratomileusis surgery and dry eye following cataract surgery, as well as in contact lens wearers and visual display terminal users. Diquafosol ophthalmic solution 3 % was generally well tolerated in patients with dry eye, with eye irritation the most commonly reported adverse event. In conclusion, diquafosol ophthalmic solution 3 % is a useful option for the treatment of dry eye.

Comparison of corneal safety and intraocular pressure-lowering effect of tafluprost ophthalmic solution with other prostaglandin ophthalmic solutions.

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Kumagami, Takeshi; Wakiyama, Harumi; Kusano, Mao; Kajiyama, Ayano; Miura, Yoko; Uematsu, Masafumi; Yoneda, Ai; Kurihara, Junko; Suzuma, Kiyoshi; Kitaoka, Takashi

2014-05-01

The benzalkonium chloride (BAK) content of tafluprost ophthalmic solution (Tapros(®): tafluprost) has been reduced to balance corneal safety and preservative effectiveness (old formulation: 0.01%; new formulation: 0.001%). However, no reports have been published on its clinical effect. Therefore, we conducted a clinical research study to compare the safety of BAK-reduced tafluprost on the ocular surface with other prostaglandin ophthalmic solutions. This clinical study included 28 glaucoma patients (28 eyes) with a treatment history of latanoprost ophthalmic solution (Xalatan(®)) or travoprost ophthalmic solution (Travatan Z(®)), who presented with corneal epithelial disorders. The subjects were switched to BAK-reduced tafluprost, and its effect on the ocular surface was examined after 1 and 2 months of treatment [using fluorescein staining score, hyperemia, tear film breakup time, and intraocular pressure (IOP) lowering]. In all analyzed subjects (N=27), the fluorescein staining score was significantly improved after switching to BAK-reduced tafluprost (P<0.0001). Conversely, the IOP-lowering effect was not notably changed. The subjects switched from latanoprost (n=10) showed significant improvement in fluorescein staining score (P<0.05) as well as in IOP lowering (P<0.01). The subjects switched from travoprost (n=17) also showed significant improvement in fluorescein staining score (P<0.001), but without a significant change in IOP lowering. Tafluprost with reduced BAK has potential as a superior antiglaucoma drug, not only for its IOP-lowering effect, but also for its good corneal safety profile.

Lifitegrast Ophthalmic Solution 5%: A Review in Dry Eye Disease.

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Keating, Gillian M

2017-02-01

Lifitegrast is a novel small molecule integrin antagonist that blocks the binding of intercellular adhesion molecule 1 (ICAM-1) to lymphocyte function-associated antigen 1 (LFA-1). Lifitegrast ophthalmic solution 5% (Xiidra™) was recently approved in the USA for the treatment of dry eye disease. The efficacy of lifitegrast ophthalmic solution 5% was compared with vehicle in a 12-week phase 2 study and three 12-week phase 3 studies (OPUS-1, OPUS-2 and OPUS-3) in patients with dry eye disease. Taken as a whole, results of these trials support the treatment effect of lifitegrast ophthalmic solution 5% in improving a symptom of dry eye disease (i.e. the change from baseline to day 84 in the eye dryness visual analogue scale score) and a sign of dry eye disease (i.e. the change from baseline to day 84 in the inferior corneal fluorescein staining score). Lifitegrast ophthalmic solution 5% was generally well tolerated. In conclusion, lifitegrast ophthalmic solution 5% provides a new option for the treatment of dry eye disease.

Development and Effects of FTY720 Ophthalmic Solution on Corneal Allograft Survival.

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Liu, Zhaochuan; Lin, Haotian; Huang, Chulong; Chen, Wan; Xiang, Wu; Geng, Yu; Chen, Weirong

2015-11-12

Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution are also unknown. Thus, we developed 0.1%, 0.2% and 0.5% FTY720 ophthalmic solutions and evaluated their chemical stabilities under various storage conditions with high- performance liquid chromatography. To investigate the ocular irritancy of the FTY720 ophthalmic solution, New Zealand albino rabbits were subjected to the Draize test. Furthermore, classic, well-established rat allogenic penetrating keratoplasty models were used to investigate the anti-rejection efficacy of the tested FTY720 ophthalmic solutions. We found that the non-irritating 0.5% FTY720 ophthalmic solution could prolong corneal allograft survival in rats with significant efficacy for about one month. Furthermore, no significant concentration changes occurred in any of the types of FTY720 ophthalmic solutions within three months. These results revealed crucial profiles of FTY720 ophthalmic solutions and warrant further investigation and optimization of FTY720 in the anti-rejection therapy after keratoplasty.

Rate of bacterial eradication by ophthalmic solutions of fourth-generation fluoroquinolones.

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Callegan, Michelle C; Novosad, Billy D; Ramadan, Raniyah T; Wiskur, Brandt; Moyer, Andrea L

2009-04-01

Antibacterial activity of ophthalmic fourth-generation fluoroquinolones has traditionally been evaluated by comparing only their active ingredients, gatifloxacin and moxifloxacin. However, ophthalmic formulations of fourth-generation fluoroquinolones differ in terms of the inclusion of preservatives. While gatifloxacin ophthalmic solution 0.3% (Zymar; Allergan, Inc., Irvine, CA, USA) contains 0.005% benzalkonium chloride (BAK), moxifloxacin ophthalmic solution 0.5% (Vigamox; Alcon Laboratories, Inc., Fort Worth, TX, USA) is preservative-free. Recent studies have demonstrated that the presence of BAK dramatically affects the antibacterial activity of the ophthalmic formulation of gatifloxacin. This study was designed to compare the kill rates of ophthalmic solutions of fourth-generation fluoroquinolones against isolates of common ocular bacterial pathogens. Approximately 5.6 log(10) colony-forming units (CFU)/mL of Haemophilus influenzae (n=1), Streptococcus pneumoniae (n=1), Staphylococcus aureus (n=2), methicillin-resistant Staphylococcus aureus (MRSA) (n=4), methicillinresistant Staphylococcus epidermidis (MRSE) (n=4), and fluoroquinolone-resistant S. epidermidis (n=1) were incubated with ophthalmic solutions of either gatifloxacin or moxifloxacin. Viable bacteria were quantified at specific time points up to 60 minutes. Gatifloxacin 0.3% completely eradicated H. influenzae and Strep. pneumoniae in 5 minutes, one of two S. aureus isolates in 15 minutes, and the other S. aureus isolate in 60 minutes. Gatifloxacin 0.3% completely killed all MRSA, MRSE, and fluoroquinolone-resistant S. epidermidis isolates in 15 minutes. Moxifloxacin 0.5% completely eradicated Strep. pneumoniae and one of four MRSA isolates in 60 minutes. All other isolates incubated with moxifloxacin 0.5% retained viable bacteria ranging from 1.8 to 4.4 log(10) CFU/mL. The ophthalmic solution of gatifloxacin 0.3% eradicated bacteria that frequently cause postoperative ocular infections

Diquafosol ophthalmic solution for dry eye treatment.

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Nakamura, Masatsugu; Imanaka, Takahiro; Sakamoto, Asuka

2012-07-01

There has been rapid progress in our understanding of dry eye pathogenesis, as well as the development of improved diagnostic clinical tests. Various types of dry eye treatment drugs have been developed. This review summarizes the basic and clinical research carried out in the development of diquafosol for ophthalmic use. Diquafosol is a dinucleotide, purinoreceptor P2Y(2) receptor agonist. Basic pharmacological studies have shown that it acts on P2Y(2) receptors at the ocular surface, to promote tear and mucin secretion via elevated intracellular Ca(2+) concentrations. Diquafosol also improves tear and mucin secretion in experimental dry eye models. Based on the results of laboratory experiments, the authors conducted a series of clinical studies in patients with dry eye disease. Diquafosol was effective in the treatment of dry eye disease at an optimal dose of 3% six times a day. In comparison to commercially available 0.1% sodium hyaluronate ophthalmic solution, 3% diquafosol ophthalmic solution showed non-inferiority in improving corneal fluorescein staining scores and superiority in improving keratoconjunctival Rose Bengal staining scores. Diquafosol ophthalmic solution has a novel mechanism of action that is characterized by its stimulatory effects on tear and mucin secretion. This drug has the potential to be effective in patients with tear film instability and short break-up time type of dry eye, which are essential factors in dry eye pathogenesis.

Effects of viscoelastic ophthalmic solutions on cell cultures

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Madhavan Hajib

1998-01-01

Full Text Available The development of mild but significant inflammation probably attributable to viscoelastic ophthalmic solutions in cataract surgery was recently brought to the notice of the authors, and hence a study of the effects of these solutions available in India, on cell cultures was undertaken. We studied the effects of 6 viscoelastic ophthalmic solutions (2 sodium hyaluronate designated as A and B, and 4 hydroxypropylmethylcellulose designated as C, D, E and F on HeLa, Vero and BHK-21 cell lines in tissue culture microtitre plates using undiluted, 1:10 and 1:100 dilutions of the solutions, and in cover slip cultures using undiluted solutions. Phase contrast microscopic examination of the solutions was also done to determine the presence of floating particles. The products D and F produced cytotoxic changes in HeLa cell line and these products also showed the presence of floating particles under phase contrast microscopy. Other products did not have any adverse effects on the cell lines nor did they show floating particles. The viscoelastic ophthalmic pharmaceutical products designated D and F have cytotoxic effects on HeLa cell line which appears to be a useful cell line for testing these products for their toxicity. The presence of particulate materials in products D and F indicates that the methods used for purification of the solution are not effective.

21 CFR 524.1484e - Neomycin sulfate and polymyxin B sulfate ophthalmic solution.

Science.gov (United States)

2010-04-01

... ophthalmic solution. 524.1484e Section 524.1484e Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution. (a...

Terapia combinada con timolol/dorzolamida versus timolol/pilocarpina en el glaucoma primario de ángulo abierto Combined therapy with timolol and dorzolamide vs timolol and pilocarpine used in primary open-angle glaucoma

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Frank García González

2006-06-01

Full Text Available El propósito de este trabajo fue evaluar la eficacia de la terapia combinada, timolol/dorzolamida, en comparación con timolol/pilocarpina. Se empleó tratamiento médico en 38 pacientes con glaucoma primario de ángulo abierto, a los que se les colocó en forma aleatoria timolol 0,5 %/dorzolamida 2 % (n. 19 o timolol 0,5 % y pilocarpina 2 % (n. 19 y posteriormente se analizaron los descensos de presión intraocular, efectividad durante cuatro semanas, efectos adversos locales y sistémicos. En el grupo de pacientes tratados con timolol/dorzolamida la presión intraocular media inicial (sin tratamiento descendió de 22,84 ± 1,77 mm Hg hasta 18,24 ± 1,84 mm Hg a las cuatro semanas de tratamiento, p. 0,01 (reducción de 4,60 mm Hg 22,14 %. En el grupo de pacientes tratados con timolol/pilocarpina la presión intraocular media inicial (sin tratamiento descendió de 23, 06 ± 1,29 mm Hg hasta 19,07 ± 1,23 mm Hg a la cuarta semana de tratamiento, p. 0,01 (reducción de 3,95 mm Hg /17,31 %, no se observaron diferencias significativas (p > 0,05 entre ambos tratamientos y fueron igualmente eficaces para reducir la presión intraocular. La calidad de vida de los pacientes que recibieron la dorzolamida como tratamiento coadyuvante fue superior, la dosificación disminuyó con respecto a la pilocarpina y no se presentaron efecto secundarios, tales como limitaciones para conducir y leer o dolor ocular, aunque refirieron sabor amargo cinco pacientes (26,31 % e irritación conjuntival dos pacientes (10,52 % relacionados con la dorzolamida. A mediano plazo se obtiene disminución de presión intraocular con dorzolamida como con la pilocarpina combinadas con el timolol. La dorzolamida demostró menos interferencia con la calidad de vida que la pilocarpinaThe objective of this study was to evaluate the efficacy of combined therapy with timolol and dorzolamide compared to timolol and pilocarpine. Thirty eight patients with primary open-angle glaucoma were

Efficacy and safety of benzalkonium chloride-free fixed-dose combination of latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension

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Bhagat P

2014-06-01

Full Text Available Purvi Bhagat,1 Kalyani Sodimalla,2 Chandrima Paul,3 Surinder S Pandav,4 Ganesh V Raman,5 Rengappa Ramakrishnan,6 Abhijeet Joshi,7 Atul Raut7 1Glaucoma Clinic, M & J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, Gujarat, India; 2Glaucoma Department, PBMA’s H.V. Desai Eye Hospital, Maharashtra, India; 3Glaucoma Service, B B Eye Foundation, Kolkata, India; 4Advanced Eye Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India; 5Glaucoma Clinic, Aravind Eye Hospital, Coimbatore, Tamilnadu, India; 6Glaucoma Clinic, Aravind Eye Hospital, Tirunelveli, Tamilnadu, India; 7Clinical Research Department, Sun Pharma Advanced Research Company Ltd, Mumbai, Maharashtra, India Background: Benzalkonium chloride (BAK is a common preservative in topical ocular preparations; however, prolonged use may lead to deleterious effects on the ocular surface, affecting quality of life and reducing adherence to treatment and overall outcomes. This study compared the intraocular pressure (IOP-lowering efficacy and safety of a novel once-daily, BAK-free, fixed-dose combination of latanoprost plus timolol with latanoprost or timolol administered as monotherapy or concomitantly. Methods: This was a 6-week, randomized, open-label, parallel-group, active-controlled study in patients aged ≥18 years with open-angle glaucoma or ocular hypertension. A total of 227 patients were randomized to either a once-daily, BAK-free, fixed-dose combination of latanoprost 0.005%/timolol 0.5% ophthalmic solution or concomitant administration of once-daily latanoprost 0.005% plus twice-daily timolol 0.5% or once-daily latanoprost 0.005% monotherapy, or twice-daily timolol 0.5% monotherapy. Efficacy end points were assessed at three time points on visits at weeks 1, 2, 4, and 6 versus baseline. Results: The IOP-lowering efficacy of the fixed-dose combination of latanoprost/timolol was similar to that of latanoprost plus timolol administered

Degree and duration of corneal anesthesia after topical application of 0.4% oxybuprocaine hydrochloride ophthalmic solution in ophthalmically normal dogs.

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Douet, Jean-Yves; Michel, Julien; Regnier, Alain

2013-10-01

To assess the anesthetic efficacy and local tolerance of topically applied 0.4% oxybuprocaine ophthalmic solution to in dogs and compare its effects with those of 1% tetracaine solution. 34 ophthalmically normal Beagles. Dogs were assigned to 2 groups, and baseline corneal touch threshold (CTT) was measured bilaterally with a Cochet-Bonnet aesthesiometer. Dogs of group 1 (n = 22) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and saline (0.9% NaCl) solution (control treatment) in the contralateral eye. Dogs of group 2 (n = 12) received a single drop of 0.4% oxybuprocaine ophthalmic solution in one eye and 1% tetracaine ophthalmic solution in the contralateral eye. The CTT of each eye was measured 1 and 5 minutes after topical application and then at 5-minute intervals until 75 minutes after topical application. CTT changes over time differed significantly between oxybuprocaine-treated and control eyes. After instillation of oxybuprocaine, maximal corneal anesthesia (CTT = 0) was achieved within 1 minute, and CTT was significantly decreased from 1 to 45 minutes, compared with the baseline value. No significant difference in onset, depth, and duration of corneal anesthesia was found between oxybuprocaine-treated and tetracaine-treated eyes. Conjunctival hyperemia and chemosis were detected more frequently in tetracaine-treated eyes than in oxybuprocaine-treated eyes. Topical application of oxybuprocaine and tetracaine similarly reduced corneal sensitivity in dogs, but oxybuprocaine was less irritating to the conjunctiva than was tetracaine.

78 FR 27971 - Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not...

Science.gov (United States)

2013-05-13

...] Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale... ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This... ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION...

The 24-hour intraocular pressure control by tafluprost/timolol fixed combination after switching from the concomitant use of tafluprost and timolol gel-forming solution, in patients with primary open-angle glaucoma

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Nakamoto K

2018-02-01

Full Text Available Kenji Nakamoto,1 Masahiko Takeshi,2 Toshihiko Hiraoka,2,3 Mayuko Eguchi,2,4 Yuichiro Nakano,1,2 Naomi Otsuka,5 Hiroko Hizaki,5 Hiromi Akai,5 Masayo Hashimoto5 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Hiraoka Eye Clinic, Saitama, Japan; 4Musashiurawa Eye Clinic, Saitama, Japan; 5Japan Medical Affairs, Global R&D, Santen Pharmaceutical Co., Ltd., Osaka, Japan Objective: The aim of this study was to evaluate the 24-hour intraocular pressure (IOP-control effect of the tafluprost/timolol fixed combination (TAF/TIM-FC in patients with primary open-angle glaucoma after they switched from the concomitant use of tafluprost and timolol gel-forming solution. Patients and methods: Twenty patients with primary open-angle glaucoma (12 male and 8 female; mean ± SD age, 57.0±7.1 years were included in this study. The patients were treated for 8 weeks with the concomitant administration of tafluprost and timolol gel-forming solution (evening dosing. At the end of this period, the patients underwent 24-hour IOP monitoring (measured at 21:00, 01:00, 05:00, 09:00, 13:00 and 17:00. IOP was measured with Goldmann applanation tonometer (GAT and Icare PRO at sitting position at all timepoints and additionally, at supine position with Icare PRO tonometer at 01:00 and 05:00. The patients were then all switched to TAF/TIM-FC treatment (evening dosing. After 8 weeks, the 24-hour IOP monitoring was repeated. Results: Nineteen patients completed the study. The mean 24-hour IOPs in the concomitant and TAF/TIM-FC phases were 13.8±2.7 vs 13.3±2.8 mmHg (P=0.0033 with the GAT in the sitting position and 13.96±2.56 vs 13.48±2.56 mmHg (P=0.0120 with the Icare PRO in habitual positions. In comparison with the concomitant phase, significantly lower IOP was observed for the TAF/TIM-FC phase at 21:00 and 01:00 with the GAT and at 01:00 with the Icare PRO. In addition, the maximum IOP and fluctuations in IOP in

76 FR 71044 - Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale...

Science.gov (United States)

2011-11-16

...] Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale for Reasons of... Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was... approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution, 0.004%, if all other...

Preference for a fixed combination of brinzolamide/timolol versus dorzolamide/timolol among patients with open-angle glaucoma or ocular hypertension.

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Sanseau, Ana; Sampaolesi, Juan; Suzuki, Emilio Rintaro; Lopes, Joao Franca; Borel, Hector

2013-01-01

To assess ocular discomfort upon instillation and patient preference for brinzolamide/timolol relative to dorzolamide/timolol, in patients with open-angle glaucoma or ocular hypertension. This was a multicenter, prospective, patient-masked, randomized, crossover study. On day 0, patients received one drop of brinzolamide/timolol in one eye and one drop of dorzolamide/timolol in the contralateral eye. On day 1, patients were randomly assigned to receive one drop of either brinzolamide/timolol or dorzolamide/timolol in both eyes; on day 2, patients received one drop of the alternate treatment in both eyes. Measures included a patient preference question on day 2 (primary) and mean ocular discomfort scale scores on days 1 and 2 (secondary). Safety assessments included adverse events, visual acuity, and slit-lamp examinations. Of 120 patients who enrolled, 115 completed the study. Of these, 112 patients instilled both medications and expressed a study medication preference on day 2. A significantly greater percentage preferred brinzolamide/timolol to dorzolamide/timolol (67.0% versus 30.4%; P day 2:1.9 [2.3] versus 3.7 [2.8], respectively [P = 0.0003]; both days combined: 2.1 [2.5] versus 3.5 [2.9], respectively [P = 0.00014]). On day 1, five patients receiving brinzolamide/timolol reported five nonserious adverse events (AEs): flu (n = 1), bitter taste (n = 2), and headache (n = 2). Four events, bitter taste (two events) and headache (two events), were considered related to brinzolamide/timolol. Events were mild in intensity, except bitter taste of moderate intensity reported by one patient. No AEs were reported at day 2. All AEs resolved without additional treatment. No clinically relevant changes from baseline were observed in best-corrected visual acuity or slit-lamp examinations of ocular signs. Patients had less discomfort with brinzolamide/timolol than with dorzolamide/timolol, and more expressed a preference for brinzolamide/timolol. Both treatments were

Efficacy of bromfenac sodium ophthalmic solution for treatment of dry eye disease.

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Fujishima, Hiroshi; Fuseya, Miki; Ogata, Masarou; Murat, Dogru

2015-01-01

To evaluate the efficacy of bromfenac sodium ophthalmic solution (BF) in patients with dry eye disease (DED) inadequately controlled by monotherapy with artificial tears (ATs). An investigator-oriented trial with a single-arm, nonrandomized, open-label design. Twenty-six patients, who showed no symptomatic improvement of DED after 1 month of AT treatment, were enrolled. Bromfenac sodium ophthalmic solution was administered adjunctively with AT for 1 month. The BF treatment was then discontinued, and AT treatment alone was continued for 3 months. The signs and symptoms were evaluated at the beginning of BF treatment (Pre), at the end of the combined BF and AT treatment (BF1M), and at 1 and 3 months after discontinuation of BF treatment (Po1M and Po3M, respectively). The dryness scores at BF1M were significantly improved compared with Pre (P ophthalmic solution has improved the dryness of the eye and signs of DED through its anti-inflammatory effects. Nonsteroidal anti-inflammatory drugs were suitable as anti-inflammatory ophthalmic solutions for patients with DED.

Preference for a fixed combination of brinzolamide/timolol versus dorzolamide/ timolol among patients with open-angle glaucoma or ocular hypertension

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Sanseau A

2013-02-01

Full Text Available Ana Sanseau,1 Juan Sampaolesi,2 Emilio Rintaro Suzuki Jr,3 Joao Franca Lopes,4 Hector Borel51Instituto de la Visión, Ciudad de Buenos Aires, Argentina; 2Consultorio Oftalmologico Sampaolesi, Ciudad de Buenos Aires, Argentina; 3Oftalmoclinica Curitiba, Curitiba, Brazil; 4Hospital El Salvador, Providencia, Chile; 5Fundacion Oftalmologica Los Andes, Vitacura Santiago, ChileObjective: To assess ocular discomfort upon instillation and patient preference for brinzolamide/timolol relative to dorzolamide/timolol, in patients with open-angle glaucoma or ocular hypertension.Methods: This was a multicenter, prospective, patient-masked, randomized, crossover study. On day 0, patients received one drop of brinzolamide/timolol in one eye and one drop of dorzolamide/timolol in the contralateral eye. On day 1, patients were randomly assigned to receive one drop of either brinzolamide/timolol or dorzolamide/timolol in both eyes; on day 2, patients received one drop of the alternate treatment in both eyes. Measures included a patient preference question on day 2 (primary and mean ocular discomfort scale scores on days 1 and 2 (secondary. Safety assessments included adverse events, visual acuity, and slit-lamp examinations.Results: Of 120 patients who enrolled, 115 completed the study. Of these, 112 patients instilled both medications and expressed a study medication preference on day 2. A significantly greater percentage preferred brinzolamide/timolol to dorzolamide/timolol (67.0% versus 30.4%; P < 0.001. The ocular discomfort (expressed as mean [standard deviation] with brinzolamide/timolol was significantly lower than with dorzolamide/timolol (day 2: 1.9 [2.3] versus 3.7 [2.8], respectively [P = 0.0003]; both days combined: 2.1 [2.5] versus 3.5 [2.9], respectively [P = 0.00014]. On day 1, five patients receiving brinzolamide/timolol reported five nonserious adverse events (AEs: flu (n = 1, bitter taste (n = 2, and headache (n = 2. Four events, bitter taste

Formulation and stability of an extemporaneous 0.02% chlorhexidine digluconate ophthalmic solution

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Shu-Chiao Lin

2015-12-01

Conclusion: The acetate-buffered 0.02% chlorhexidine digluconate ophthalmic solution stored in light-resistant high-density polyethylene eyedroppers demonstrated excellent stability at 2–25°C for 6 months after being sealed and for 1 month after opening. This finding will enable us to prepare 0.02% chlorhexidine digluconate ophthalmic solutions based on a doctor's prescription.

Comparison of the effects of ophthalmic solutions on human corneal epithelial cells using fluorescent dyes.

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Xu, Manlong; Sivak, Jacob G; McCanna, David J

2013-11-01

To investigate the effect of differently preserved ophthalmic solutions on the viability and barrier function of human corneal epithelial cells (HCEC) using fluorescent dyes. HCEC monolayers were exposed to the ophthalmic solutions containing benzalkonium chloride (BAK), edetate disodium, polyquad, stabilized oxychloro complex (Purite), sodium perborate, or sorbic acid for 5 min, 15 min, and 1 h. At 24 h after exposure, the cultures were assessed for metabolic activity using alamarBlue. The enzyme activity, membrane integrity, and apoptosis were evaluated using confocal microscopy. Barrier function was assessed using sodium fluorescein. The metabolic assay showed that the BAK-preserved ophthalmic solutions significantly reduced cell viability after a 5-min exposure compared to the phosphate buffered saline treated control (POphthalmic solutions with new preservatives had varying time-dependent adverse effects on cell viability, and the preservative-free solution had the least effect on HCEC. Sodium fluorescein permeability showed that HCEC monolayers treated with BAK-preserved solutions were more permeable to sodium fluorescein than those treated by the other ophthalmic solutions (Psolutions had greater adverse effects on metabolic activity, enzyme activity, membrane integrity, cell viability, and barrier function than the solutions that were not preserved with BAK. Our study suggests that BAK-free especially, preservative-free ophthalmic solutions are safer alternatives to BAK-preserved ones.

Long-term results of treatment with diquafosol ophthalmic solution for aqueous-deficient dry eye.

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Koh, Shizuka; Ikeda, Chikako; Takai, Yoshihiro; Watanabe, Hitoshi; Maeda, Naoyuki; Nishida, Kohji

2013-09-01

To evaluate the preliminary long-term efficacy of diquafosol ophthalmic solution for aqueous-deficient dry eye. Fifteen patients with mild-to-moderate aqueous-deficient dry eye were enrolled. After a washout period, the patients were treated with 3 % diquafosol ophthalmic solution for 6 months. We assessed 12 subjective dry eye symptoms, corneal and conjunctival staining with fluorescein, tear film break-up time (BUT), lower tear meniscus height measured with anterior-segment optical coherence tomography, Schirmer's testing, and adverse reactions at baseline and 1, 3, and 6 months after the start of treatment. Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining, BUT, and tear meniscus height at 1 month and maintained the effectiveness for 6 months. Conjunctival staining significantly improved 3 and 6 months after treatment. No significant adverse reactions developed. Prolonged use of diquafosol ophthalmic solution for 6 months produced significant improvement both subjectively (dry eye symptom score) and objectively (ocular staining score and tear function tests) for aqueous-deficient dry eye.

Development and Effects of FTY720 Ophthalmic Solution on Corneal Allograft Survival

OpenAIRE

Zhaochuan Liu; Haotian Lin; Chulong Huang; Wan Chen; Wu Xiang; Yu Geng; Weirong Chen

2015-01-01

Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution...

Effect of textured eye drop bottles on the photostability of pranoprofen 0.1% ophthalmic solution.

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Iwatsuka, Kinya; Inada, Katsuhiro; Ueoka, Hiroki; Otsuka, Tadashi; Maeda, Masaki; Yamaguchi, Masazumi; Yasueda, Shin-ichi

2015-01-01

Ophthalmic solutions are usually filled in a plastic bottle due to its durability and disposability. In Japan, photostability is one of the concerns for the quality control because an eye drop bottle must be a transparent container. The present work studied the effect of textured eye drop bottles on its light blocking to improve the photostability of ophthalmic solutions. We investigated the photostability of Pranoprofen ophthalmic solution filled in a variety of textured eye drop bottles. Pranoprofen content was analyzed by high-performance liquid chromatography and surface structure of textured eye drop bottles was evaluated by transmittance, calculated average roughness (Ra) and haze intensity. We observed that eye drop bottle which had greater than Ra value of 1.0 µm and haze intensity 62% clearly showed photostability improvement. This report is the first one which shows that photostability of ophthalmic solution is improved by using textured eye drop bottle. Moreover, this approach is a simple and effective method to improve the photostability. This method is available for not only various ophthalmic applications but also other liquid pharmaceuticals or food products.

Comparison of the efficacy and safety of fixed combination travoprost/timolol and dorzolamide/timolol in patients with primary open-angle glaucoma and ocular hypertension

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Babić Nikola

2013-01-01

Full Text Available Introduction. Combining two medications in one bottle may improve compliance by reducing the time required to administer drops and the frequency of the total number of medication bottles. Objective. To compare the efficacy of reduced intraocular pressure (IOP and safety of fixed combination travoprost 0.004%/timolol 0.5% vs. fixed combination dorzolamide 2%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Methods. Prospective randomized clinical study included 60 patients divided into 2 groups. Follow-up was done at day 14 and 45 and month 3. IOP measurements were taken at each follow-up examination at 8 am, 10 am and 4 pm. Results. Both fixed combinations reduced IOP significantly compared to initial values at all follow-ups (p<0.001. Mean pooled IOP at all visits and time points was slightly lower in the travoprost/timolol group compared with the dorzolamide/timolol group (16.13 mmHg vs. 16.15 mmHg. Mean IOP reduction from baseline ranged from -7.46 mmHg to -9.92 mmHg in the travoprost/timolol group and from -6.93 mmHg to -8.93 mmHg for the dorzolamide/timolol group. Mean (±standard error of the mean reduction in diurnal IOP from baseline to 3rd month was 8.96±2.79 in the travoprost/timolol group versus 8.07±2.91 in patients receiving dorzolamide/timolol fixed combination (p=0.196. The most frequent treatment-related adverse events were conjunctival hyperemia in the travoprost/timolol group, and dry eye and foreign body sensation in the dorzolamide/timolol group. Conclusion. Travoprost/timolol fixed combination was slightly more effective than dorzolamide/timolol fixed combination in reducing mean diurnal IOP. Travoprost/timolol group resulted in an IOP reduction for up to 1.07 mmHg higher than dorzolamide/timolol group. Both fixed combinations were well tolerated and safe.

Comparison of Drug Concentrations in Human Aqueous Humor after the Administration of 0.3% Gatifloxacin Ophthalmic Gel, 0.3% Gatifloxacin and 0.5% Levofloxacin Ophthalmic Solutions.

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Ding, Wenting; Ni, Weiling; Chen, Huilian; Yuan, Jingqun; Huang, Xiaodan; Zhang, Zheng; Wang, Yao; Yu, Yibo; Yao, Ke

2015-01-01

To investigate the penetration of 0.3% gatifloxacin ophthalmic gel, 0.3% gatifloxacin ophthalmic solution and 0.5% levofloxacin ophthalmic solution into aqueous humor after topical application. Age-related cataract patients (150 eyes in 150 cases) receiving phacoemulsification were randomly divided into three groups: a 0.3% gatifloxacin gel group (n=50), a 0.3% gatifloxacin solution group (n=50), and a 0.5% levofloxacin solution group (n=50). Each group was administered one drop of gel or solution every 15 minutes for four doses. Aqueous samples were collected at different time points after the last drop. High pressure liquid chromatography (HPLC) was applied to determine the concentrations. The one-way ANOVA analysis was performed. Our data indicated that the concentration of the gatifloxacin gel group was higher than that of the gatifloxacin solution group at all time points (P solution group at 120.0 min and 180.0 min (Psolutions reached their peak values at 60.0 min. 0.3% gatifloxacin ophthalmic gel application produced highest aqueous humor drug concentration, maintained the longest time, had the best penetration and bioavailability.

Diclofenac Ophthalmic

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Diclofenac ophthalmic solution is used to treat eye pain, redness, and swelling in patients who are recovering ... treat clouding of the lens in the eye). Diclofenac ophthalmic solution is also used to temporarily relieve ...

Influence of Ophthalmic Solutions on Tear Components.

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Shigeyasu, Chika; Yamada, Masakazu; Akune, Yoko

2016-11-01

Tear fluids are a mixture of secretions derived from lacrimal glands, accessory lacrimal glands, conjunctiva, and meibomian glands. Compositional changes to tears occur in the normal state and during ocular surface disease, such as dry eye conditions. We have investigated compositional changes to tears after topical application of ophthalmic solutions, with regard to tear-specific proteins (secretory immunoglobulin A, lactoferrin, lipocalin-1, and lysozyme) and ocular surface mucin in normal and dry eye conditions using high-performance liquid chromatography. After application of saline solution (0.9% sodium chloride) in normal subjects, transient but significant decreases in all tear components were observed. The recovery of protein concentrations took up to 30 minutes and lasted longer when the saline solution was applied more frequently. When applying ophthalmic solutions, a balance between washout and dilutional effects should be considered in addition to the therapeutic effect. Investigation of the effect of diquafosol solution (3%) in normal subjects revealed a significant increase in sialic acid concentration, a marker of ocular mucin, at 5 minutes after application, whereas a significant decrease was observed with saline. This result indicates the accelerated secretion of mucin from ocular tissues induced by diquafosol. A clinical study to determine the efficacy of diquafosol in patients with dry eye revealed improvements in tear breakup time, keratoconjunctival staining scores, and Schirmer test score, accompanied by an increase in sialic acid concentration in tears. Investigating normal and dry eye conditions through tear analysis may clarify the pathophysiology of dry eye conditions and support the efficacy of treatments.

Antioxidant activity of dorzolamide/timolol fixed combination in neuroprotective therapy in glaucoma

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N. I. Kurysheva

2012-01-01

Full Text Available Purpose: to study the antioxidant activity of carbonic anhydrase inhibitors and timolol fixed combinations and to compare it with other fixed combinations.Methods: Antioxidant activity (AOA of dorzolamide/timolol (Cosopt, dorzolamide/timolol (Dorzopt Plus, latanoprost/timolol, brimonidine/timolol, travoprost/timolol and bimatoprost/timolol fixed combinations was measured in vitro using the model of oxida- tive hemolysis.Results: Dorzolamide/timolol (Cosopt AOA was higher than that of other fixed combinations and increased with the quantity of the drugs added to the model system: 40%, 52% and 75% in 30 μl, 60 μl and 90 μl respectively.Conclusion: these findings suggest that dorzolamide/timolol fixed combination has potential advantages over the other fixed combinations due to its high antioxidant activity and might be used as the neuroptotective agent for glaucoma treatment.

75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

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2010-09-08

... Ophthalmic Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment... acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and... GENTOCIN DURAFILM (gentamicin sulfate and betamethasone acetate) Ophthalmic Solution, sponsored by Intervet...

Comparison of systemic absorption between ofloxacin ophthalmic in situ gels and ofloxacin conventional ophthalmic solutions administration to rabbit eyes by HPLC-MS/MS.

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Li, Jiawei; Zhao, Hainan; Okeke, Chukwunweike Ikechukwu; Li, Lin; Liu, Zhidong; Yin, Zhongpeng; Zhuang, Pengwei; Sun, Jingtong; Wu, Tao; Wang, Meng; Li, Nan; Pi, Jiaxin; Zhang, Qian; Zhang, Rui; Ma, Li; Pang, Xiaochen; Liu, Zhanbiao; Zhang, Li; Fan, Lili

2013-06-25

In recent years, many pharmaceutical scientists have focused on developing the in situ gel-forming systems to overcome the poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid pre-corneal elimination of the drug. The present work was to compare the systemic absorptions of ophthalmic ofloxacin in situ gel with the conventional ofloxacin eye drop after topical instillation to rabbit eyes by HPLC-MS/MS method and also determine the relative contribution of the nasal and the conjunctival mucosae to systemic ofloxacin absorption following topical instillation. The systemic AUC, Cmax, Tmax and Ke for ophthalmic in situ gel and ophthalmic solution after ocular instillation were 202.63±118.85 and 202.25±57.74 ng mL(-1) h, 54.22±28.31 and 48.4±25.97 ng mL(-1), 1.08±0.20 and 1.25±0.88 h, 0.0576±0.0207 and 0.0388±0.0248, respectively. And the values for the ratios of the AUC of anterior chamber of rabbit eye to blood plasma, AUCac/AUCpl, for ofloxacin conventional eye drop and in situ gel were 0.25 and 0.52, respectively. Statistic results showed that there was no significant difference in systemic absorption between the test groups and the reference groups (P>0.05) as both formulations have an AUCsa/AUCpl of 0.35. Therefore, the ophthalmic in situ gel may not decrease the drugs systemic absorption when administered in an equivalent dose as ophthalmic solutions into the rabbit eyes. Copyright © 2013 Elsevier B.V. All rights reserved.

Efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% in patients transitioning from bimatoprost 0.03%/timolol 0.5% combination therapy

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Schnober D

2015-05-01

Full Text Available Dietmar Schnober,1 Douglas A Hubatsch,2 Maria-Luise Scherzer3 1Private Ophthalmology Practice, Werdohl, Germany; 2Alcon Laboratories, Inc., Fort Worth, TX, USA; 3Private Ophthalmology Practice, Regenstauf, Germany Purpose: To determine the efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% preserved with polyquaternium-1 in patients with insufficient response to bimatoprost 0.03%/timolol 0.5% preserved with benzalkonium chloride.Patients and methods: In this open-label nonrandomized study conducted at 13 European sites, patients with primary open-angle glaucoma or ocular hypertension with insufficient intraocular pressure (IOP reduction during bimatoprost/timolol therapy were transitioned to travoprost/timolol (DuoTrav® administered every evening for 12 weeks. Change in IOP from baseline to week 12 was assessed in patients who transitioned from fixed-combination bimatoprost/timolol (n=57, primary endpoint. Secondary assessments included change in IOP at week 4, percentage of patients with IOP ≤18 mmHg at weeks 4 and 12, change in Ocular Surface Disease Index and ocular hyperemia scores at week 12, and patient preference. Adverse events were also reported.Results: IOP change (mean ± SD from baseline to week 12 was –3.8±1.9 mmHg (P<0.001; results were similar at week 4. Most patients had IOP ≤18 mmHg at weeks 4 and 12 (78.6% and 85.5%, respectively. Mean Ocular Surface Disease Index score was significantly reduced (P<0.001; no significant change in ocular hyperemia score was observed (P=0.197. Treatment-related adverse events included dysgeusia, nausea, paresthesia, myalgia, headache, and eye irritation (n=1 each. Most patients (74.5% preferred travoprost/timolol over bimatoprost/timolol.Conclusion: Transition to travoprost/timolol significantly reduced IOP and was well tolerated in patients who had elevated IOP despite bimatoprost/timolol therapy. Polyquaternium-1–preserved travoprost/timolol was preferred over

Evaluation of the cytotoxic effects of ophthalmic solutions containing benzalkonium chloride on corneal epithelium using an organotypic 3-D model.

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Khoh-Reiter, Su; Jessen, Bart A

2009-07-28

Benzalkonium chloride (BAC) is a common preservative used in ophthalmic solutions. The aim of this study was to compare the cytotoxic effects of BAC-containing ophthalmic solutions with a BAC-free ophthalmic solution using an organotypic 3-dimensional (3-D) corneal epithelial model and to determine the effects of latanoprost ophthalmic solution and its BAC-containing vehicle on corneal thickness in a monkey model. The cytotoxicity of commercially available BAC-containing ophthalmic formulations of latanoprost (0.02% BAC) and olopatadine (0.01% BAC) was compared to that of BAC-free travoprost and saline in a corneal organotypic 3-D model using incubation times of 10 and 25 minutes. To compare the extent of differentiation of 3-D corneal cultures to monolayer transformed human corneal epithelial (HCE-T) cell cultures, expression levels (mRNA and protein) of the corneal markers epidermal growth factor receptor, transglutaminase 1 and involucrin were quantified. Finally, latanoprost ophthalmic solution or its vehicle was administered at suprapharmacologic doses (two 30 microL drops twice daily in 1 eye for 1 year) in monkey eyes, and corneal pachymetry was performed at baseline and at weeks 4, 13, 26 and 52. In the 3-D corneal epithelial culture assays, there were no significant differences in cytotoxicity between the BAC-containing latanoprost and olopatadine ophthalmic solutions and BAC-free travoprost ophthalmic solution at either the 10- or 25-minute time points. The 3-D cultures expressed higher levels of corneal epithelial markers than the HCE-T monolayers, indicating a greater degree of differentiation. There were no significant differences between the corneal thickness of monkey eyes treated with latanoprost ophthalmic solution or its vehicle (both containing 0.02% BAC) and untreated eyes. The lack of cytotoxicity demonstrated in 3-D corneal cultures and in monkey studies suggests that the levels of BAC contained in ophthalmic solutions are not likely to cause

Evaluation of the cytotoxic effects of ophthalmic solutions containing benzalkonium chloride on corneal epithelium using an organotypic 3-D model

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Jessen Bart A

2009-07-01

Full Text Available Abstract Background Benzalkonium chloride (BAC is a common preservative used in ophthalmic solutions. The aim of this study was to compare the cytotoxic effects of BAC-containing ophthalmic solutions with a BAC-free ophthalmic solution using an organotypic 3-dimensional (3-D corneal epithelial model and to determine the effects of latanoprost ophthalmic solution and its BAC-containing vehicle on corneal thickness in a monkey model. Methods The cytotoxicity of commercially available BAC-containing ophthalmic formulations of latanoprost (0.02% BAC and olopatadine (0.01% BAC was compared to that of BAC-free travoprost and saline in a corneal organotypic 3-D model using incubation times of 10 and 25 minutes. To compare the extent of differentiation of 3-D corneal cultures to monolayer transformed human corneal epithelial (HCE-T cell cultures, expression levels (mRNA and protein of the corneal markers epidermal growth factor receptor, transglutaminase 1 and involucrin were quantified. Finally, latanoprost ophthalmic solution or its vehicle was administered at suprapharmacologic doses (two 30 μL drops twice daily in 1 eye for 1 year in monkey eyes, and corneal pachymetry was performed at baseline and at weeks 4, 13, 26 and 52. Results In the 3-D corneal epithelial culture assays, there were no significant differences in cytotoxicity between the BAC-containing latanoprost and olopatadine ophthalmic solutions and BAC-free travoprost ophthalmic solution at either the 10- or 25-minute time points. The 3-D cultures expressed higher levels of corneal epithelial markers than the HCE-T monolayers, indicating a greater degree of differentiation. There were no significant differences between the corneal thickness of monkey eyes treated with latanoprost ophthalmic solution or its vehicle (both containing 0.02% BAC and untreated eyes. Conclusion The lack of cytotoxicity demonstrated in 3-D corneal cultures and in monkey studies suggests that the levels of BAC

[Optimization of benzalkonium chloride concentration in 0.0015% tafluprost ophthalmic solution from the points of ocular surface safety and preservative efficacy].

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Asada, Hiroyuki; Takaoka-Shichijo, Yuko; Nakamura, Masatsugu; Kimura, Akio

2010-06-01

Optimization of benzalkonium chloride (alkyl dimethylbenzylammonium chloride: BAK) concentration as preservative in 0.0015% tafluprost ophthalmic solution (Tapros 0.0015% ophthalmic solution), an anti-glaucoma medicine, was examined from the points of ocular surface safety and preservative efficacy. BAKC(12), which is dodecyl dimethylbenzylammonium chloride, and BAKmix, which is the mixture of dodecyl, tetradecyl and hexadecyl dimethylbenzylammonium chloride were used in this study. The effects of BAKC(12) concentrations and the BAK types, BAKC(12) and BAKmix, in tafluprost ophthalmic solution on ocular surface safety were evaluated using the in vitro SV 40-immobilized human corneal epithelium cell line (HCE-T). Following treatments of Tafluprost ophthalmic solutions with BAKC(12), its concentration dependency was observed on cell viability of HCE-T. The cell viability of HCE-T after treatment of these solutions with 0.001% to 0.003% BAKC(12) for 5 minutes were the same level as that after treatment of the solution without BAK. Tafluprost ophthalmic solution with 0.01% BAKC(12) was safer for the ocular surface than the same solution with 0.01% BAKmix. Preservatives-effectiveness tests of tafluprost ophthalmic solutions with various concentrations of BAKC(12) were performed according to the Japanese Pharmacopoeia (JP), and solutions with more than 0.0005% BAKC(12) conformed to JP criteria. It was concluded that 0.0005% to 0.003% of BAKC(12) in tafluprost ophthalmic solution was optimal, namely, well-balanced from the points of ocular surface safety and preservative efficacy.

Efficiency, safety, and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog

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Shimizu Y

2015-03-01

Full Text Available Yoshie Shimizu,1 Shunsuke Nakakura,1 Makiko Nishiyama,1 Hitoshi Tabuchi,1 Yoshiaki Kiuchi2 1Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, 2Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan Background: We investigated the efficiency, safety and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog.Methods: We initially enrolled 44 eyes from 44 primary open angle glaucoma patients, and a total of 42 patients completed the study. All patients were under treatment with various prostaglandin F2α analogs and dorzolamide 1%/timolol 0.5%. While maintaining the prostaglandin F2α analog, dorzolamide 1%/timolol 0.5% was switched to brinzolamide 1%/timolol 0.5%. Conjunctival hyperemia, superficial punctate keratopathy, and intraocular pressure (IOP were evaluated at baseline and at 4, 12, and 24 weeks. Adverse events and patient preferences, measured using a questionnaire at study initiation and at 24 weeks, were also noted.Results: The IOP was 17.7±1.7, 16.8±2.6, 16.7±2.2, and 16.7±2.4 mmHg at baseline and at 4, 12, and 24 weeks, respectively, with no significant differences in IOP values at any time point (P=0.117, one-way analysis of variance. In addition, no significant differences were found in the incidence of conjunctival hyperemia or SPK score at any time point (all P>0.5, by Kruskal–Wallis test. Based on the evaluation of side effects using the questionnaire, stinging/burning was less common (P=0.042, while blurred vision was more common (P=0.003, after switching to brinzolamide 1%/timolol 0.5%. Regarding patient preferences, 13 patients (31% preferred dorzolamide 1%/timolol 0.5%, 12 patients (29% preferred brinzolamide 1%/timolol 0.5%, and 17 patients (40% preferred neither.Conclusion: When switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1

Efficiency, safety, and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog.

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Shimizu, Yoshie; Nakakura, Shunsuke; Nishiyama, Makiko; Tabuchi, Hitoshi; Kiuchi, Yoshiaki

2015-01-01

We investigated the efficiency, safety and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog. We initially enrolled 44 eyes from 44 primary open angle glaucoma patients, and a total of 42 patients completed the study. All patients were under treatment with various prostaglandin F2α analogs and dorzolamide 1%/timolol 0.5%. While maintaining the prostaglandin F2α analog, dorzolamide 1%/timolol 0.5% was switched to brinzolamide 1%/timolol 0.5%. Conjunctival hyperemia, superficial punctate keratopathy, and intraocular pressure (IOP) were evaluated at baseline and at 4, 12, and 24 weeks. Adverse events and patient preferences, measured using a questionnaire at study initiation and at 24 weeks, were also noted. The IOP was 17.7±1.7, 16.8±2.6, 16.7±2.2, and 16.7±2.4 mmHg at baseline and at 4, 12, and 24 weeks, respectively, with no significant differences in IOP values at any time point (P=0.117, one-way analysis of variance). In addition, no significant differences were found in the incidence of conjunctival hyperemia or SPK score at any time point (all P>0.5, by Kruskal-Wallis test). Based on the evaluation of side effects using the questionnaire, stinging/burning was less common (P=0.042), while blurred vision was more common (P=0.003), after switching to brinzolamide 1%/timolol 0.5%. Regarding patient preferences, 13 patients (31%) preferred dorzolamide 1%/timolol 0.5%, 12 patients (29%) preferred brinzolamide 1%/timolol 0.5%, and 17 patients (40%) preferred neither. When switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5%, the IOP values and incidence of superficial punctate keratopathy and conjunctival hyperemia were sustained throughout the 24-week observation period, and the patient preferences were similar for the two regimens. However, differences were observed in the ocular sensations of stinging/burning with dorzolamide 1%/timolol 0

Local toxicity of benzalkonium chloride in ophthalmic solutions following repeated applications.

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Okahara, Akihiko; Kawazu, Kouichi

2013-01-01

We performed repeated toxicity studies of benzalkonium chloride (BAK)-containing vehicles of ophthalmic solutions in monkeys and rabbits to assess the local toxicity of BAK after repeated applications on the ocular surface. Local toxicity of BAK was evaluated by toxicity studies in which a 0.01% BAK-containing vehicle was applied twice/day for 52 weeks, 4 times/day for 39 weeks, or 6 times/day for 13 weeks, or in which a 0.005% BAK-containing vehicle was applied 6 times/day for 52 weeks or twice/day for 4 weeks in monkeys. Local toxicity of BAK was also evaluated where a 0.01% BAK-containing vehicle was applied 6 times/day for 6 weeks, or a 0.005% BAK-containing vehicle was applied twice/day for 39 weeks or 8 times/day for 4 weeks in rabbits. These doses were chosen because BAK is generally used at concentrations up to 0.01% in ophthalmic solutions. The BAK-containing vehicle did not cause ophthalmological changes suggestive of irritation, allergy, or corneal damage. We also did not observe any histopathological changes in the eyeball, eyelid, lacrimal gland, and nasal cavity, with repeated applications of BAK for up to 52 weeks, up to 8 times/day, or at concentrations up to 0.01%, in monkeys and rabbits. Our results suggest that BAK in concentrations up to 0.01% in ophthalmic solution is non-toxic to the eyeball, its accessory organs, and the nasal cavity after long repeated applications.

Comparison of dorzolamide/timolol vs brinzolamide/brimonidine fixed combination therapy in the management of primary open-angle glaucoma.

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Kozobolis, Vassileios; Panos, Georgios D; Konstantinidis, Aristeidis; Labiris, Georgios

2017-03-10

To compare the efficiency of brinzolamide/brimonidine fixed combination vs the dorzolamide/timolol fixed combination. Forty-four eyes of 44 patients were divided in 2 groups treated either with dorzolamide/timolol twice a day (group A) or with brinzolamide/brimonidine twice a day (group B). Complete ophthalmic examination including Goldmann applanation tonometry was performed before treatment administration and 1, 4, 8, and 12 weeks afterwards. The intraocular pressure (IOP) was measured twice a day (morning at 9 AM and afternoon at 4 PM). At the end of the follow-up period (12 weeks), mean morning IOP reduction was 7.0 ± 2.8 mm Hg in group A and 8.4 ± 1.9 mm Hg in group B. A significant difference was found (p = 0.0343). In contrast, mean afternoon IOP reduction was 8.6 ± 2.7 mm Hg in group A and 7.9 ± 1.6 mm Hg in group B and no significant difference was found (p = 0.3413). No significant adverse effects were observed in either group. Brinzolamide/brimonidine seems to be an effective and safe alternative β-blocker free fixed combination, especially for patients with comorbidities, having its own antihypertensive profile.

Antimicrobial activity of a new preservative for multiuse ophthalmic solutions.

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Ghelardi, Emilia; Celandroni, Francesco; Gueye, Sokhna A; Salvetti, Sara; Campa, Mario; Senesi, Sonia

2013-01-01

The aim of this study was to examine the antimicrobial activity and the preservative efficacy of a novel preservative solution containing sodium hydroxymethyl glycinate (SHMG) and edetate disodium (EDTA), which is used for preservation of some commercial ophthalmic formulations. In vitro susceptibility assays were performed against several gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, and Bacillus cereus) and gram-negative (Escherichia coli and Pseudomonas aeruginosa) bacteria representative of the microbial flora of epithelial surfaces or colonizing the conjunctiva, as well as against Candida albicans and Aspergillus niger. Using different concentrations of SHMG alone or in combination with EDTA, the minimal inhibitory and microbicidal concentrations against these organisms were assessed. In addition, 8 brands of multidose eye drops containing 0.002% SHMG and 0.1% EDTA as preservative were tested for antimicrobial activity using the antimicrobial effectiveness test recommended by the international pharmacopoeias. The minimal inhibitory and bactericidal/fungicidal concentration values of SHMG ranged from 0.0025% to 0.0125% for bacteria and from 0.125% to 0.50% for mold and yeast. Susceptibility testing demonstrated that the addition of EDTA substantially increased the SHMG activity against all bacterial and fungal strains. The preservative effectiveness test was applied to commercial eye drops. All the drop solutions met the criteria reported by the U.S. Pharmacopeia for parenteral and ophthalmic preparations. All products also satisfied the major acceptance criteria of the European Pharmacopeia with respect to the antifungal activity. With regard to the antibacterial activity, the less-stringent criteria of the European Pharmacopeia were fulfilled. The present study demonstrates the efficacy of a novel preservative for ophthalmic solutions (SHMG/EDTA) and its activity in protecting selected commercial artificial tears against microbial

76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

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2011-12-29

.... FDA-2011-N-0003] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... solution of ivermectin. DATES: This rule is effective December 29, 2011. FOR FURTHER INFORMATION CONTACT... ANADA 200-318 for [[Page 81807

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes

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Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT)”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. PMID:26028958

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes.

Science.gov (United States)

Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of "Tear Film Oriented Therapy (TFOT)", an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described.

75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

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2010-05-12

.... FDA-2010-N-0002] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... are treated with a topical solution of ivermectin. DATES: This rule is effective May 12, 2010. FOR... ANADA 200-340 for PRIVERMECTIN (ivermectin), a topical solution used on cattle to control infestations...

Facilitation of tear fluid secretion by 3% diquafosol ophthalmic solution in normal human eyes.

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Yokoi, Norihiko; Kato, Hiroaki; Kinoshita, Shigeru

2014-01-01

To evaluate the increase in tear fluid volume induced by 3% diquafosol ophthalmic solution in normal human eyes. Prospective, randomized, double-masked, comparative study. Twenty healthy adults (17 males and 3 females; mean age, 38.8 years) underwent topical instillation of 2 ophthalmic solutions, artificial tears in 1 eye and 3% diquafosol ophthalmic solution in the fellow eye, in a masked manner. The radius of curvature of the central lower tear meniscus was measured at 5, 10, 15, 30, and 60 minutes after instillation by use of reflective meniscometry, and subjects' self-evaluated symptoms of wetness and stinging using a visual analog scale. Changes after instillation in the radius of curvature from baseline (artificial tear group vs diquafosol group; mean ± standard error of the mean) were as follows: at 5 minutes, -0.008 ± 0.012 vs 0.045 ± 0.013; at 10 minutes, 0.001 ± 0.014 vs 0.057 ± 0.016; at 15 minutes, -0.012 ± 0.014 vs 0.037 ± 0.019; at 30 minutes, -0.010 ± 0.016 vs 0.030 ± 0.025; and at 60 minutes, -0.029 ± 0.012 vs -0.020 ± 0.012. The diquafosol group showed significantly greater values from 5 to 30 minutes after instillation. Of the 40 eyes, 13 showed abnormal tear film breakup time (≤5 seconds). The diquafosol group had significantly more wetness at 15 minutes after instillation than did the artificial tear group. Topical instillation of 3% diquafosol ophthalmic solution increases tear fluid on the ocular surface for up to 30 minutes in normal human eyes. Copyright © 2014 Elsevier Inc. All rights reserved.

The efficacy and safety of bimatoprost/timolol maleate, latanoprost/timolol maleate, and travoprost/timolol maleate fixed combinations on 24-h IOP.

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Guven Yilmaz, Suzan; Degirmenci, Cumali; Karakoyun, Yunus Emre; Yusifov, Emil; Ates, Halil

2017-06-14

To evaluate the effect of bimatoprost/timolol maleate fixed combination (BTFC), latanoprost/timolol maleate fixed combination (LTFC), and travoprost/timolol maleate fixed combination (TTFC) on 24-h intraocular pressure (IOP) in patients with open-angle glaucoma. This prospective, observer-masked, randomized study included 50 patients with primary open-angle glaucoma. All patients were using hypotensive lipids and timolol maleate fixed combination treatment for ≥4 weeks and had an IOP ≤ 21 mmHg. Group 1 (n = 18) received BTFC, group 2 (n = 14) received LTFC, and group 3 (n = 18) received TTFC. All patients were hospitalized, and IOP was monitored for 24-h (10:00, 14:00, 18:00, 22:00, 02:00, and 06:00). Mean diurnal IOP variation measurements were taken between 06:00 and 18:00, and mean nocturnal IOP variation measurements were taken between 22:00 and 02:00. Mean IOP and IOP variation in the three groups were compared. Mean 24-h IOP did not differ significantly between the three groups (group 1: 14.6 ± 2.9 mmHg; group 2: 14.1 ± 3.7 mmHg and group 3: 15.8 ± 2.0 mmHg; P > 0.05). Mean diurnal IOP variation was 4.6 ± 2.3 mmHg in group 1, 5.8 ± 2.4 mmHg in group 2, and 4.3 ± 1.7 mmHg in group 3, and mean nocturnal IOP variation was 3.2 ± 2.8 mmHg in group 1, 2.9 ± 1.9 mmHg in group 2, and 3.0 ± 1.6 mmHg group 3. There were not any significant differences in diurnal or nocturnal IOP variation between the three groups (P < 0.05). All three fixed combinations effectively controlled IOP for 24-h and had a similar effect on diurnal and nocturnal IOP variations.

Brimonidine 0.2% given two or three times daily versus timolol maleate 0.5% in primary open-angle glaucoma.

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Konstas, A G; Stewart, W C; Topouzis, F; Tersis, I; Holmes, K T; Stangos, N T

2001-06-01

To evaluate the efficacy and safety of brimonidine 0.2% two or three times daily versus timolol maleate 0.5% solution twice daily. Patients with primary open-angle glaucoma were randomized by Latin square technique to one of the three treatment sequences in this crossover, prospective double-masked trial. Each treatment period consisted of 6 weeks of chronic dosing followed by a diurnal curve for the intraocular pressure measured at 08:00, 10:00, 16:00, 18:00, 20:00, 22:00, and 24:00 hours. Intraocular pressure was measured by applanation tonometry. Thirty patients completed this trial. The average diurnal intraocular pressures in the trial were measured for timolol maleate (17.7 +/- 2.7 mm Hg), brimonidine given three times daily (18.0 +/- 2.2 mm Hg), and brimonidine given twice daily (19.2 +/- 2.4 mm Hg). There was a statistical difference between groups (P <.005). When groups were compared by pairs, three times daily dosing with brimonidine and timolol maleate both reduced the pressure more than twice daily brimonidine at every time point past 10:00 hours and for the diurnal curve (P <.05). In contrast, three times daily brimonidine and timolol maleate were statistically similar for the diurnal pressure, and each time point, except timolol maleate, decreased the pressure more at 16:00 (P =.042). Safety was similar between groups. This study demonstrated that both timolol maleate twice daily and brimonidine three times daily provide a similar intraocular pressure reduction to each other. Timolol maleate twice daily and brimonidine three times daily provide a greater decrease in pressure in the late afternoon and nighttime hours, compared with brimonidine twice daily.

[Randomized parallel group study of 0.0015% tafluprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension (comparison with 0.005% latanoprost ophthalmic solution)].

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Ge, Jian; Li, Xiaoxin; Sun, Xinghuai; He, Xiangge; Zhang, Hong

2015-02-01

To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups. This study was conducted from August 2008 to December 2009, at five clinical trial sites in China. Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group.Intraocular pressure (IOP) measurement by Goldmann applanation tonometer, slit-lamp microscopy, Gonioscopy, Fundascopy, Visual acuity test, Perimetry, Blood pressure and pulse rate, Subjective symptoms were compered between two groups at Week 0, Week 2 and Week 4.For main effectiveness evaluation index adopt the bad effect evaluation, safety evaluation index by Fisher's exact test probability method. The 246 subjects/246 eyes were randomized (Tafluprost group:122 subjects/122 eyes, Latanoprost group:124 subjects/ 124 eyes). Change in the IOP at 17:00 of Week 2 is (8.8 ± 3.8) mmHg and (8.9 ± 4.4) mmHg (1 mmHg = 0.133 kPa) in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 of Week 2 is (33.2 ± 12.8)% and (34.4 ± 14.1)% in Tafluprost group and Latanoprost group. Change in the IOP at 17:00 at the end of treatment is (9.8 ± 4.0) mmHg and (9.2 ± 4.1) mmHg in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 at the end of treatment is 37.2% ± 13.4% group and 35.7% ± 13.0% in Tafluprost and Latanoprost group.In addition, distribution of subjects with percentage decrease of IOP > 30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group. The major adverse reactions were conjunctival hyperemia, eye irritation, eye pain and foreign body sensation. The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group. The inter

Effects of 0.2% brimonidine and 0.2% brimonidine-0.5% timolol on intraocular pressure and pupil size in normal equine eyes.

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Von Zup, M; Lassaline, M; Kass, P H; Miller, P E; Thomasy, S M

2017-11-01

Brimonidine is an α 2 -adrenergic agonist that decreases aqueous humour production and may increase uveoscleral outflow. It has not been evaluated in normal or glaucomatous equine eyes. To evaluate the efficacy and safety of brimonidine in lowering intraocular pressure (IOP), alone and in conjunction with timolol, as a treatment for equine glaucoma by comparing IOP in normal equine eyes treated with brimonidine and brimonidine-timolol, respectively, with IOP in control eyes. A balanced crossover design with 16 horses receiving one of two treatments, brimonidine and brimonidine-timolol, during each of two 10-day study phases, was used. Four horses were randomly assigned to each of four combinations of treated eye (right or left) and drug order within the two 10-day study phases (brimonidine first or brimonidine-timolol first). Pupil size and conjunctival hyperaemia were assessed twice per day and IOP was measured three times per day using rebound tonometry in both eyes of 16 normal horses throughout two 10-day study periods (brimonidine and brimonidine-timolol) separated by an 18-day washout period. One eye of each horse was treated with brimonidine or brimonidine-timolol and the opposite eye was treated with balanced salt solution (BSS). There were no adverse effects and no significant changes in pupil size in normal equine eyes treated with brimonidine or brimonidine-timolol. Average IOP in normal equine eyes treated with brimonidine (25.6 mmHg) was statistically higher than in eyes treated with brimonidine-timolol (24.6 mmHg) or BSS (24.5 mmHg). However, IOP differences were of ≤1 mmHg and thus not clinically important. Horses with normal eyes may not be as sensitive to the IOP-lowering effects of treatment as horses with glaucoma. Brimonidine and brimonidine-timolol are well tolerated in normal horses but do not decrease IOP. © 2017 EVJ Ltd.

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes

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Koh S

2015-05-01

Full Text Available Shizuka Koh Department of Ophthalmology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan Abstract: Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. Keywords: diquafosol, dry eye, mucin secretion, fluid secretion, ocular surface, vision

Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial.

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Matsumoto, Yukihiro; Ohashi, Yuichi; Watanabe, Hitoshi; Tsubota, Kazuo

2012-10-01

To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1%, n = 96; 3%, n = 96) or placebo ophthalmic solution (n = 94). After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1% or 3% diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Fluorescein corneal staining scores significantly improved with both 1% and 3% topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1% and 3% diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Both 1% and 3% diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Bioavailability and biochemical effects of diclofenac sodium 0.1% ophthalmic solution in the domestic chicken (Gallus gallus domesticus).

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Griggs, Angela N; Yaw, Taylor J; Haynes, Joseph S; Ben-Shlomo, Gil; Tofflemire, Kyle L; Allbaugh, Rachel A

2017-03-01

To determine if topical ophthalmic diclofenac sodium 0.1% solution alters renal parameters in the domestic chicken, and to determine if the drug is detectable in plasma after topical ophthalmic administration. Thirty healthy domestic chickens. Over 7 days, six birds were treated unilaterally with one drop of artificial tear solution (group 1), 12 birds were treated unilaterally (group 2) and 12 bilaterally (group 3) with diclofenac sodium 0.1% ophthalmic solution. Treatments were provided every 12 h in all groups. Pre- and post-treatment plasma samples from all birds were evaluated for changes in albumin, total protein, and uric acid. Post-treatment samples of all birds, collected 15 min post-administration, were analyzed by high-performance liquid chromatography with mass spectrometry for diclofenac sodium detection. A randomly selected renal sample from each group was submitted for histopathologic review. Changes in pre- and post-treatment plasma albumin were significant (P Ophthalmic diclofenac sodium 0.1% administered topically every 12 h in one or both eyes for 7 days is detectable in systemic circulation in the domestic chicken, but does not cause overt significant changes in plasma uric acid or total protein. © 2016 American College of Veterinary Ophthalmologists.

Immediate Effects of 3% Diquafosol and 0.1% Hyaluronic Acid Ophthalmic Solution on Tear Break-Up Time in Normal Human Eyes.

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Nam, Ki Tae; Ahn, So Min; Eom, Youngsub; Kim, Hyo Myung; Song, Jong Suk

2015-12-01

The purpose of this study was to evaluate the immediate effect of 3% diquafosol ophthalmic solution on tear break-up time (TBUT) in normal human eyes, and to compare it with that of saline and 0.1% hyaluronate ophthalmic solution. Cross sectional comparative study in the first study, 10 healthy volunteers underwent topical application of 2 different ophthalmic solutions in each eye. Saline was randomly applied to one eye and 3% diquafosol ophthalmic solution was added to the fellow eye. TBUT was measured and video recorded before application and at 5, 10, 15, and 20 min after. The TBUT in each eye was compared at each time point with regard to the 2 different ophthalmic solutions. In the second study, another 10 healthy volunteers were included. The same methods were used to compare the immediate effects of 0.1% hyaluronate and 3% diquafosol ophthalmic solution application on TBUT. In the first study, topical instillation of saline did not increase TBUT. However, 3% diquafosol significantly increased TBUT for up to 15 min after application. At every time point, the TBUT increased more significantly from baseline in the diquafosol group than it did in the saline group. In the second study, 0.1% hyaluronate increased TBUT for up to 5 min after application, while 3% diquafosol increased TBUT for up to 15 min. Although the TBUT changes after 5 min were not significantly different between the 2 groups, the TBUT changes at 10, 15, and 20 min were significantly greater in the 3% diquafosol group than they were in the 0.1% hyaluronic acid group (+1.58 ± 0.82 vs. +0.53 ± 1.36 at 10 min, +0.67 ± 0.91 vs. -0.04 ± 1.29 at 15 min, and -0.06 ± 0.96 vs. -0.59 ± 0.90, diquafosol group vs. hyaluronic acid group). One drop of 3% diquafosol increased TBUT for up to 15 min after application. The immediate effect of 3% diquafosol on TBUT was greater than that of saline and even that of 1% hyaluronate ophthalmic solution.

Formulation and stability of an extemporaneous 0.02% chlorhexidine digluconate ophthalmic solution.

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Lin, Shu-Chiao; Huang, Chih-Fen; Shen, Li-Jiuan; Wang, Hsueh-Ju; Lin, Chia-Yu; Wu, Fe-Lin Lin

2015-12-01

Acanthamoeba keratitis is difficult to treat because Acanthamoeba cysts are resistant to the majority of antimicrobial agents. Despite the efficacy of 0.02% chlorhexidine in treating Acanthamoeba keratitis, a lack of data in the literature regarding the formulation's stability limits its clinical use. The objective of this study was to develop an optimal extemporaneous 0.02% chlorhexidine digluconate ophthalmic formulation for patients in need. With available active pharmaceutical ingredients, 0.02% chlorhexidine digluconate sample solutions were prepared by diluting with BSS Plus Solution or acetate buffer. Influences of the buffer, type of container, and temperature under daily-open condition were assessed based on the changes of pH values and chlorhexidine concentrations of the test samples weekly. To determine the beyond-use date, the optimal samples were stored at 2-8°C or room temperature, and analyzed at time 0 and at Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, Week 12, and Week 24. Despite chlorhexidine exhibiting better stability in acetate buffer than in BSS solution, its shelf-life was stability at 2-25°C for 6 months after being sealed and for 1 month after opening. This finding will enable us to prepare 0.02% chlorhexidine digluconate ophthalmic solutions based on a doctor's prescription. Copyright © 2014. Published by Elsevier B.V.

The ocular distribution of 14C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model

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Baklayan GA

2014-09-01

Full Text Available George A Baklayan, Mauricio Muñoz Bausch + Lomb, Irvine, CA, USA Purpose: To evaluate the ocular distribution of an advanced formulation of bromfenac ophthalmic solution. Two studies were conducted in rabbits: 1 a 12-hour parallel-group study comparing the ocular distribution of 14C-bromfenac ophthalmic solution 0.07%, pH 7.8 with that of 14C-bromfenac ophthalmic solution 0.09%, pH 8.3, and 2 a 24-hour study evaluating the ocular distribution of 14C-bromfenac ophthalmic solution 0.07%, pH 7.8.Methods: In the 12-hour study, rabbits were randomized to receive 50 µL of 14C-bromfenac 0.07%, pH 7.8 or 50 µL 14C-bromfenac 0.09%, pH 8.3 in one eye, whereas, in the 24-hour, study both eyes received 50 µL of 14C-bromfenac 0.07%, pH 7.8. Ocular tissues were collected at 1, 2, 4, 8, 12 (both studies and 24 hours (second study only following drug instillation, and tissue radioactivity was determined using liquid scintillation chromatography. Results: Measureable levels of bromfenac were observed in all ocular tissues, with the exception of vitreous humor, regardless of formulation. In the 12-hour study, high concentrations of 14C-bromfenac were found in the sclera, followed by the iris/ciliary body, aqueous humor, choroid, retina, and lens. There was no significant difference between the bromfenac 0.07%, pH 7.8 and bromfenac 0.09%, pH 8.3 formulations in any 14C-bromfenac tissue levels at any time point, with the exception of in sclera at 2 hours post-instillation (0.451 µg eq/g versus 0.302 µg eq/g, respectively, P<0.001. There was also no significant difference in the total amount of 14C-bromfenac in the tissues evaluated following instillation of the two formulations. In the 24-hour study evaluating bromfenac 0.07%, pH 7.8 only, high concentrations of 14C-bromfenac were found 1 hour post-instillation in the cornea (2.402 µg eq/g and conjunctiva (1.049 µg eq/g, two tissues not evaluated in the 12-hour study. The rank order of 14C

An ophthalmic solution of a peroxisome proliferator-activated receptor gamma agonist prevents corneal inflammation in a rat alkali burn model.

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Uchiyama, Masaaki; Shimizu, Akira; Masuda, Yukinari; Nagasaka, Shinya; Fukuda, Yuh; Takahashi, Hiroshi

2013-01-01

We clarified the effects of an ophthalmic solution of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist on corneal inflammation and wound healing after alkali burn injury in rats. After alkali exposure, either an ophthalmic solution with 0.1% pioglitazone hydrochloride (the PPARγ group) or vehicle (the vehicle group) was topically applied to the cornea until day 14. Histological, immunohistochemical, and real-time reverse transcription polymerase chain reaction analysis were performed. After alkali injury, PPARγ expression increased, with the infiltration of many inflammatory cells. The infiltration of neutrophils and macrophages started from the corneal limbus within 6 h, and developed in the corneal center by day 7, with associated neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of type III collagen were noted on day 14. The histological changes were suppressed significantly by treatment with the ophthalmic solution of the PPARγ agonist. In addition, the number of infiltrating M2 macrophages in the cornea was increased by PPARγ agonist treatment. In real-time reverse transcription polymerase chain reaction analysis, the messenger ribonucleic acid expression levels of interleukin-1β (IL-1β), IL-6, IL-8, monocyte chemoattractant protein-1, tumor necrosis factor-α, transforming growth factor beta 1, and vascular endothelial growth factor-A were decreased in the PPARγ group compared to the vehicle group in the early periods of corneal inflammation. The ophthalmic solution of the PPARγ agonist inhibited inflammation, decreased the fibrotic reaction, and prevented neovascularization in the cornea from the early phase after alkali burn injury. The ophthalmic solution of the PPARγ agonist may provide a new treatment strategy with useful clinical applications for corneal inflammation and wound healing.

Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial.

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Toshida, Hiroshi; Funaki, Toshinari; Ono, Koichi; Tabuchi, Nobuhito; Watanabe, Sota; Seki, Tamotsu; Otake, Hiroshi; Kato, Takuji; Ebihara, Nobuyuki; Murakami, Akira

2017-01-01

The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye. This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks ( P ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.

Ophthalmic regional blocks: management, challenges, and solutions

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Palte HD

2015-08-01

Full Text Available Howard D Palte Department of Anesthesiology, Perioperative Medicine and Pain Management, Miller School of Medicine, University of Miami, Miami, FL, USA Abstract: In the past decade ophthalmic anesthesia has witnessed a major transformation. The sun has set on the landscape of ophthalmic procedures performed under general anesthesia at in-hospital settings. In its place a new dawn has ushered in the panorama of eye surgeries conducted under regional and topical anesthesia at specialty eye care centers. The impact of the burgeoning geriatric population is that an increasing number of elderly patients will present for eye surgery. In order to accommodate increased patient volumes and simultaneously satisfy administrative initiatives directed at economic frugality, administrators will seek assistance from anesthesia providers in adopting measures that enhance operating room efficiency. The performance of eye blocks in a holding suite meets many of these objectives. Unfortunately, most practicing anesthesiologists resist performing ophthalmic regional blocks because they lack formal training. In future, anesthesiologists will need to block eyes and manage common medical conditions because economic pressures will eliminate routine preoperative testing. This review addresses a variety of topical issues in ophthalmic anesthesia with special emphasis on cannula and needle-based blocks and the new-generation antithrombotic agents. In a constantly evolving arena, the sub-Tenon’s block has gained popularity while the deep angulated intraconal (retrobulbar block has been largely superseded by the shallower extraconal (peribulbar approach. Improvements in surgical technique have also impacted anesthetic practice. For example, phacoemulsification techniques facilitate the conduct of cataract surgery under topical anesthesia, and suture-free vitrectomy ports may cause venous air embolism during air/fluid exchange. Hyaluronidase is a useful adjuvant because it

Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence

OpenAIRE

Rajpal, Rajesh K; Ross, Bryan; Rajpal, Sachin D; Hoang, Khoa

2014-01-01

Rajesh K Rajpal, Bryan Ross, Sachin D Rajpal, Khoa HoangSee Clearly Vision Group, McLean, VA, USAAbstract: Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used by clinicians to manage ocular inflammation and pain following cataract surgery. Over the past decade, the US Food and Drug Administration has approved multiple topical NSAIDs for these purposes, including several reformulated products. One of these medications, bromfenac ophthalmic solution, has a long and extens...

Time Course of Prostaglandin Analog-related Conjunctival Hyperemia and the Effect of a Nonsteroidal Anti-inflammatory Ophthalmic Solution.

Science.gov (United States)

Sakata, Rei; Sakisaka, Toshihiro; Matsuo, Hiroshi; Miyata, Kazunori; Aihara, Makoto

2016-03-01

It is reported that nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution affected the therapeutic efficacy of prostaglandin (PG) analog by inhibiting endogenous PG production. However, whether NSAID ophthalmic solution interferes with its conjunctival hyperemia is unknown. We investigated the effect of NSAID ophthalmic solution on its hyperemia. This was a prospective, randomized, double-blind, placebo-controlled 1-month trial. Benzalkonium chloride-free travoprost 0.004% was used as a PG analog and administered once daily (08:00) in both eyes. Bromfenac sodium hydrate was assigned randomly to 1 eye twice daily (08:00 and 20:00) (the NSAID side), whereas flavin adenine dinucleotide sodium was applied to the fellow eye of each patient twice daily (08:00 and 20:00) (the control side). Conjunctival photographs of both eyes were taken 3 times (08:00, 14:00, 20:00) on days 1, 2, 7, and 28, and hyperemia was scored from 0 to 5 (H-score). We compared H-scores on the NSAID and control sides. Twenty-eight Japanese normal subjects completed the study. The H-score on the NSAID side was significantly lower than that on the control side on day 1 at 14:00 (P=0.016, paired t test) and day 2 at 14:00 (P=0.016). But there were no differences at 20:00 on each day and after that time. The use of NSAID ophthalmic solution had almost no impact on PG analog-related conjunctival hyperemia. This partly suggests that the action mechanism of endogenous PG after administrating PG analog might be no correlation with conjunctival hyperemia.

An ophthalmic solution of a peroxisome proliferator-activated receptor gamma agonist prevents corneal inflammation in a rat alkali burn model

Science.gov (United States)

Uchiyama, Masaaki; Masuda, Yukinari; Nagasaka, Shinya; Fukuda, Yuh; Takahashi, Hiroshi

2013-01-01

Purpose We clarified the effects of an ophthalmic solution of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist on corneal inflammation and wound healing after alkali burn injury in rats. Methods After alkali exposure, either an ophthalmic solution with 0.1% pioglitazone hydrochloride (the PPARγ group) or vehicle (the vehicle group) was topically applied to the cornea until day 14. Histological, immunohistochemical, and real-time reverse transcription polymerase chain reaction analysis were performed. Results After alkali injury, PPARγ expression increased, with the infiltration of many inflammatory cells. The infiltration of neutrophils and macrophages started from the corneal limbus within 6 h, and developed in the corneal center by day 7, with associated neovascularization. The accumulation of α-smooth muscle actin-positive myofibroblasts and the deposition of type III collagen were noted on day 14. The histological changes were suppressed significantly by treatment with the ophthalmic solution of the PPARγ agonist. In addition, the number of infiltrating M2 macrophages in the cornea was increased by PPARγ agonist treatment. In real-time reverse transcription polymerase chain reaction analysis, the messenger ribonucleic acid expression levels of interleukin-1β (IL-1β), IL-6, IL-8, monocyte chemoattractant protein-1, tumor necrosis factor-α, transforming growth factor beta 1, and vascular endothelial growth factor-A were decreased in the PPARγ group compared to the vehicle group in the early periods of corneal inflammation. Conclusions The ophthalmic solution of the PPARγ agonist inhibited inflammation, decreased the fibrotic reaction, and prevented neovascularization in the cornea from the early phase after alkali burn injury. The ophthalmic solution of the PPARγ agonist may provide a new treatment strategy with useful clinical applications for corneal inflammation and wound healing. PMID:24194635

Efficacy and Tolerability of Fixed-Combination Brinzolamide/Timolol in Latin American Patients with Open-Angle Glaucoma or Ocular Hypertension Previously on Brimonidine/Timolol Fixed Combination

OpenAIRE

Alezzandrini, Arturo; Hubatsch, Douglas; Alfaro, Rene

2014-01-01

Introduction Fixed-combination glaucoma medications are commonly used to achieve target intraocular pressure (IOP) reduction in patients uncontrolled with monotherapy; however, ocular discomfort associated with eye drops can decrease adherence. This study assessed the efficacy and tolerability of twice-daily fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) in Latin American patients transitioned from fixed-combination brimonidine 0.2%/timolol 0.5% (BRIM/TIM-FC) because of insuffi...

The role of hyaluronan as a drug carrier to enhance the bioavailability of extended release ophthalmic formulations. Hyaluronan-timolol ionic complexes as a model case.

Science.gov (United States)

Battistini, F D; Tártara, L I; Boiero, C; Guzmán, M L; Luciani-Giaccobbe, L C; Palma, S D; Allemandi, D A; Manzo, R H; Olivera, M E

2017-07-15

The aim of this work was to obtain information concerning the properties of ophthalmic formulations based on hyaluronic-drug ionic complexes, to identify the factors that determine the onset, intensity and duration of the pharmacotherapeutic effect. Dispersions of a complex of 0.5% w/v of sodium hyaluronate (HyNa) loaded with 0.5% w/v of timolol maleate (TM) were obtained and presented a counterionic condensation higher than 75%. For comparison a similar complex obtained with hyaluronic acid (HyH) was also prepared. Although the viscosity of HyNa-TM was significantly higher than that of HyH-TM, in vitro release of TM from both complexes showed a similar extended drug release profile (20-31% over 5h) controlled by diffusion and ionic exchange. Ocular pharmacokinetic study performed in normotensive rabbits showed that HyNa-TM complex exhibited attractive bioavailability properties in the aqueous humor (AUC and Cmax significantly higher and later Tmax) compared to commercial TM eye-drops. Moreover, a more prolonged period of lowered intra-ocular pressure (10h) and a more intense hypotensive activity was observed after instillation of a drop of HyNa-TM as compared to the eye-drops. Such behavior was related to the longer pre-corneal residence times (400%) observed with HyNa-TM complex. No significant changes in rabbit transcorneal permeation were detected upon complexation. These results demonstrate that the ability of HyNa to modulate TM release, together with its mucoadhesiveness related to the viscosity, affected both the pharmacokinetic and pharmacodynamic parameters. The HyNa-TM complex is a potentially useful carrier for ocular drug delivery, which could improve the TM efficacy and reduce the frequency of administration to improve patient compliance. Copyright © 2017 Elsevier B.V. All rights reserved.

Meta-analysis of timolol on diurnal and nighttime intraocular pressure and blood pressure.

LENUS (Irish Health Repository)

Lee, Princeton Wen-Yuan

2012-02-01

PURPOSE: To evaluate the nighttime intraocular pressure (IOP) and blood pressure (BP) response to timolol treatment in patients with ocular hypertension or primary open-angle glaucoma. METHODS: This was a meta-analysis of previously published studies that must have been randomized, prospective, crossover or parallel, single or double-masked trials. The treatment period must have been >\\/=2 weeks with >\\/=19 patients per treatment arm for a crossover, and >\\/=50 patients for a parallel designed trial. Studies must have included both baseline and treated 24-hour curves. RESULTS: For the IOP analysis, we included 8 articles with 340 patients. A reduction from baseline was observed for timolol at each time point and for the 24-hour curve (p<\\/=0.009). When 2 studies, in which timolol was used adjunctively, were removed, a similar difference was observed as above at each time point and for the 24-hour curve (p<\\/=0.003). In 2 studies, there were small reductions from baseline for the mean diastolic and systolic BPs at most time points and for the 24-hour curve (3.9 and 4.2 mmHg, respectively) with timolol treatment. The ocular perfusion pressure did not show any difference between baseline and timolol treatment at any time point or for the 24-hour curve (p>0.05). CONCLUSIONS: This meta-analysis suggests that topical timolol therapy provides an ocular hypotensive effect over the 24-hour curve, including the nighttime hours, and while small reductions in the systolic and diastolic pressures occur, the ocular perfusion pressure is not altered over 24 hours.

Topical ophthalmic NSAIDs: a discussion with focus on nepafenac ophthalmic suspension

OpenAIRE

Gaynes, Bruce I; Onyekwuluje, Anne

2008-01-01

Bruce I Gaynes1,2, Anne Onyekwuluje11Departments of Ophthalmology and 2Pharmacology, Rush College of Medicine, Chicago, Illinois, USAAbstract: The removal of diclofenac sodium ophthalmic solution as a viable pharmaceutical entity in September 1999 from the US market spurred considerable interest in the general safety and effectiveness of topical ophthalmic NSAIDs for treatment of anterior segment inflammation. In late 1999 the use of topical ocular NSAIDs declined in the US as a result of inc...

Diquafosol Ophthalmic Solution Increases Pre- and Postlens Tear Film During Contact Lens Wear in Rabbit Eyes.

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Nagahara, Yukiko; Koh, Shizuka; Oshita, Yoshihiro; Nagano, Takashi; Mano, Hidetoshi; Nishida, Kohji; Watanabe, Hitoshi

2017-11-01

To investigate the behavior of prelens tear film (PLTF) and postlens tear film (PoLTF) after the instillation of diquafosol using an experimental rabbit model of eyes with contact lens. Cross-sectional, anterior segment optical coherence tomographic images of the inferior midperipheral cornea were obtained at baseline and at 5, 15, 30, 60, 90, and 120 min after the instillation of 3% diquafosol ophthalmic solution in 10 Japanese white rabbits wearing contact lenses. From the obtained images, the areas of the PLTF and PoLTF were calculated. Both artificial tear solution and 0.1% sodium hyaluronate ophthalmic solution were used for comparison. Significant fluid accumulation in both the PLTF and PoLTF was observed after diquafosol instillation, whereas no fluid accumulation was visible after the instillation of artificial tear or sodium hyaluronate. The increase in PLTF area after diquafosol instillation was significantly higher (Pophthalmic solution increases PLTF and PoLTF in rabbit eyes with contact lenses. Diquafosol has potential as a treatment option for contact lens-related dry eye.

Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial

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Day, Douglas G; Walters, Thomas R; Schwartz, Gail F; Mundorf, Thomas K; Liu, Charlie; Schiffman, Rhett M; Bejanian, Marina

2013-01-01

Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was −0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated. Conclusions Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost. PMID:23743437

Efficiency, safety, and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog

OpenAIRE

Shimizu, Yoshie; Nakakura,Shunsuke; Nishiyama,Makiko; Tabuchi,Hitoshi; Kiuchi,Yoshiaki

2015-01-01

Yoshie Shimizu,1 Shunsuke Nakakura,1 Makiko Nishiyama,1 Hitoshi Tabuchi,1 Yoshiaki Kiuchi2 1Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, 2Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan Background: We investigated the efficiency, safety and patient preference of switching from dorzolamide 1%/timolol 0.5% to brinzolamide 1%/timolol 0.5% while maintaining the prostaglandin F2α analog...

Topical timolol with and without benzalkonium chloride: epithelial permeability and autofluorescence of the cornea in glaucoma.

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de Jong, C; Stolwijk, T; Kuppens, E; de Keizer, R; van Best, J

1994-04-01

Epithelial permeability and autofluorescence of the cornea were determined by fluorophotometry in 21 patients with open-angle glaucoma or ocular hypertension using timolol medication with the preservative benzalkonium chloride (BAC) and 2 weeks after changing to timolol medication without BAC. The investigation was performed to determine whether removal of BAC would reduce toxic effects on the cornea and complaints of sensations of burning or dry eye. Corneal epithelial permeability decreased significantly after changing medication (mean decrease per patient 27%, P = 0.025). Corneal autofluorescence increased significantly after changing medication suggesting an alteration in corneal metabolism (mean increase per patient 6%, P = 0.003). Timolol without BAC was found to be as effective as timolol with BAC in reducing intraocular pressure (P = 0.4). Removal of BAC from timolol resulted in an improvement of corneal epithelial barrier function and in a reduction of complaints. The improvement was found to be proportional to the duration of the preceding BAC-containing therapy.

Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye.

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Nichols, Jason J; Bickle, Katherine M; Zink, Richard C; Schiewe, Michael D; Haque, Reza M; Nichols, Kelly K

2012-03-01

The purpose of this pilot study was to evaluate the safety and efficacy of azithromycin ophthalmic solution 1% in patients with contact lens-related dry eye (CLDE). This was a 4-week, single-center, open-label clinical trial in patients diagnosed with CLDE using the Contact Lens Dry Eye Questionnaire (CLDEQ). Fifty patients were enrolled in this study. The patients were randomized to 1 of 2 treatment groups: azithromycin ophthalmic solution administered bid on days 1 and 2 and on days 3 to 29±1 or Visine for Contacts rewetting drops administered qid on days 1 to 29±1. The patient diaries were used daily to collect data on comfortable and total contact lens wear time and ocular dryness throughout the treatment period. Tear osmolarity, fluorescein corneal staining, and visual acuity were also assessed during clinic visits. Fifty patients were enrolled, and 44 completed the study. One patient discontinued in the azithromycin group, and five patients discontinued in the rewetting drops group because of adverse events. A statistically significant increase in mean comfortable contact lens wear time from baseline was observed for the subjects treated with azithromycin ophthalmic solution as compared with the subjects treated with rewetting drops at week 4 (P=0.004; primary endpoint), in addition to weeks 2 and 3. The improvement in the mean comfortable wear time for the patients in the azithromycin treatment group exceeded 2 hrs throughout the treatment period (weeks 1-4). No significant differences were observed between the groups for total wear time, low contrast visual acuity, or tear osmolarity. Subject-rated ocular dryness (PM time assessments) was significantly improved from baseline in the subjects treated with azithromycin ophthalmic solution as compared with those treated with rewetting drops at weeks 2 and 3 endpoints (P=0.015 for each week). Additionally, a statistical difference was observed in favor of the azithromycin treatment group at week 2 for the

Influence of container structures and content solutions on dispensing time of ophthalmic solutions

Directory of Open Access Journals (Sweden)

Keiji Yoshikawa

2010-05-01

Full Text Available Keiji Yoshikawa1, Hiroshi Yamada21Yoshikawa Eye Clinic, Tokyo, Japan; 2Santen Pharmaceutical Co., Ltd., Osaka, JapanPurpose: To investigate the influence of container structures and content solutions on the time of dispensing from eye dropper bottles.Methods: Eye dropper bottle models, solution models (filtrate water/surfactant solution and a dispensing time measuring apparatus were prepared to measure the dispensing time.Results: With filtrate water and pressure thrust load of 0.3 MPa, the dispensing time significantly increased from 1.1 ± 0.5 seconds to 4.6 ± 1.1 seconds depending on the decrease of inner aperture diameters from 0.4 mm to 0.2 mm (P < 0.0001. When using the bottle models with inner aperture diameters of 0.4 mm or larger, the dispensing time became constant. The dispensing time using surfactant solution showed the same tendency as above. When pressure thrust load was large (0.07 MPa, the solution flew out continuously with inner aperture diameters of 0.4 mm or larger and the dispensing time could not be measured. The inner aperture diameter most strongly explained the variation of the dispensing time in both the content solutions in the multiple linear regression analysis (filtrate water: 46%, R2 = 0.462, surfactant solution: 56%, R2 = 0.563.Conclusions: Among content solutions and container structures, the dispensing time was mostly influenced by the diameter of the inner aperture of bottles.Keywords: dispensing time, model eye dropper bottle, model ophthalmic solution, nozzle internal space volume, nozzle inner aperture diameter

Communication: an ophthalmic practice issue.

Science.gov (United States)

Whitton, S J

1995-12-01

In the 1990's communication becomes an ophthalmic practice issue. The present ophthalmic climate of cost containment, downsizing, budget cuts, and lack of appreciation of contributions, results in a low staff morale. Recognition of the effects of job satisfaction and productivity led one group to seek solutions. A communication task force was formed to identify problems and the appropriate interventions.

Three percent diquafosol ophthalmic solution as an additional therapy to existing artificial tears with steroids for dry-eye patients with Sjögren's syndrome.

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Yokoi, N; Sonomura, Y; Kato, H; Komuro, A; Kinoshita, S

2015-09-01

To investigate the long-term results of 3% diquafosol ophthalmic solution as an alternative therapy to existing ophthalmic solutions, including topical immunosuppression, for the treatment of dry eye in patients with Sjögren's syndrome. This study involved 14 female dry-eye patients (mean age: 62.4 years) with Sjögren's syndrome who insufficiently responded to their current therapy. In all patients, 3% diquafosol ophthalmic solution was administered six times daily for 12 months in substitution for artificial tears and sodium hyaluronate ophthalmic solution. Their use of corticosteroid eye drops remained unchanged from that prior to the treatment with diquafosol sodium. The subjective symptoms assessed, and ocular signs including tear meniscus radius and the tear film breakup time, and ocular-surface epithelial damage score were examined at 1, 2, 3, 4, 5, 6, 9, and 12 months after initiating treatment. Among the subjective symptoms, significant improvement was obtained in dryness at 2 months post treatment, in eye fatigue at 1, 2, 3, 4, and 12 months post treatment, and in pain at 1, 2, 6, and 12 months post treatment. Difficulty in opening the eye, foreign body sensation, and redness were also significantly ameliorated at various time-points. The tear meniscus radius and the tear film breakup time were significantly improved throughout the observation period, and the corneal epithelial staining scores were significantly decreased at 3 months post treatment. In dry-eye patients with Sjögren's syndrome, treatment with 3% diquafosol ophthalmic solution improved both symptoms and signs, and that effectiveness was maintained for 12 months.

A self-controlled study of intralesional injection of diprospan combined with topical timolol cream for treatment of thick superficial infantile hemangiomas.

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Xu, Peng; Yu, Qian; Huang, Huizhen; Zhang, Wenjie; Li, Wei

2018-04-30

Topical application of timolol cream is effective and convenient for treating superficial infantile hemangiomas. Intralesional injection of corticosteroids, such as diprospan, is useful for the treatment of superficia infantile hemangiomas without systemic side effects. We conducted a self-controlled study to investigate whether a combination of intralesional injection of diprospan with topical timolol 0.5% cream would be more efficient than timolol cream alone in thick superficial infantile hemangiomas. Thirty-eight patients with 39 thick superficial infantile hemangiomas were recruited. Each lesion was randomly divided into two equal parts: one part was treated with topical timolol 0.5% cream (timolol cream group), while the other part was treated with injection of diprospan combined with topical timolol 0.5% cream (combined treatment group). Infants were followed every 4 weeks to determine whether injections should be continued, and timolol cream was applied four times daily for 5 months. During 5 months of treatment, three specialist physicians were invited to evaluate the therapeutic effects. The combined treatment group showed better lesion involution than did the timolol cream group regarding lesion thickness and color of lesions. The combination of intralesional injection of diprospan with topical timolol 0.5% cream is a suitable and safe strategy for thick superficial infantile hemangiomas. © 2018 Wiley Periodicals, Inc.

Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas.

Science.gov (United States)

Dalla Costa, Renata; Prindaville, Brea; Wiss, Karen

2018-03-01

Topical timolol maleate has recently gained popularity as a treatment for superficial infantile hemangiomas, but calculating a safe dose of timolol can be time consuming, which may limit the medication's use in fast-paced clinical environments. This report offers a simplified calculation of the maximum daily safe dosage as 1 drop of medication per kilogram of body weight. © 2018 Wiley Periodicals, Inc.

Effects of timolol and atenolol on benign essential tremor: placebo-controlled studies based on quantitative tremor recording.

Science.gov (United States)

Dietrichson, P; Espen, E

1981-08-01

Two different beta-adrenoreceptor antagonists, atenolol and timolol, were separately compared with a placebo in the suppression of essential tremor. In two-week single-blind placebo-controlled studies with cross-over, timolol (5 mg twice daily) and atenolol (100 mg once daily) produced an equal reduction in sitting heart rate and sitting blood pressure. Timolol was effective in reducing tremor while atenolol failed to reduce tremor amplitude. These results indicate that essential tremor can be reduced but not blocked, by the adrenergic blocker timolol with both beta 1 and beta 2 blocking properties; but not by the relatively selective beta 1 blocking drug atenolol. Possibly, the tremor reduction is medicated by a peripheral effect on beta 2 adrenoreceptors.

Determination of permeability coefficients of ophthalmic drugs through different layers of porcine, rabbit and bovine eyes.

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Loch, Christian; Zakelj, Simon; Kristl, Albin; Nagel, Stefan; Guthoff, Rudolf; Weitschies, Werner; Seidlitz, Anne

2012-08-30

To treat ophthalmic diseases like glaucoma or inflammatory disorders topically applied ophthalmic formulations such as eye drops are usually used. In addition, novel ophthalmic implants releasing drug substances locally into different parts of the eye are available today. In the work presented here, the permeability coefficients of selected drugs (ciprofloxacin hydrochloride, lidocaine hydrochloride, timolol maleate) for ophthalmic tissues were determined using side-by-side diffusion chambers (so-called Ussing chambers). Sclera, conjunctiva, cornea, choroidea-retina-complex and a complex of conjunctiva-sclera-choroidea-retina were excised from fresh porcine, rabbit and bovine eyes. In the porcine eye tissues the highest P(app) values were obtained for conjunctiva with the exception of lidocaine. Therefore, it can be estimated that a certain amount of drug diffuses or is transported through conjunctiva after application. The P(app) values for sclera were also higher than those for cornea and even more, the surface area of sclera which is available for drug absorption is much larger than that of cornea when applying an implant. The obtained permeability coefficients for sclera and conjunctiva indicate that the administration of periocular implants can be an alternative to topically applied formulations. The complexes of the tissues were a significantly (p<0.01) stronger barrier to the investigated substances than the separated tissues. Distinct differences in permeability coefficients between the investigated animal tissues were observed. Overall the highest P(app) values for all mounted tissues were obtained with the rabbit, followed by porcine and bovine eyes. Because of these distinct interspecies differences one must be very careful when selecting the proper animal model for the permeability experiments. Copyright © 2012 Elsevier B.V. All rights reserved.

Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study.

Science.gov (United States)

Donnenfeld, Eric D; Karpecki, Paul M; Majmudar, Parag A; Nichols, Kelly K; Raychaudhuri, Aparna; Roy, Monica; Semba, Charles P

2016-06-01

To evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo. SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma. The safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression. Lifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events.

The Efficacy of 1% Chloramphenicol Eye Ointment Versus 2.5% Povidone-Iodine Ophthalmic Solution in Reducing Bacterial Colony in Newborn Conjunctivae.

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Bramantyo, Triwijayanti; Roeslani, Rosalina Dewi; Andriansjah, Andriansjah; Sitorus, Rita S

2015-01-01

This study aimed to evaluate bacterial pattern and reduction of bacterial colonies in neonatal conjunctivae after prophylaxis 1% chloramphenicol eye ointment and 2.5% povidone-iodine ophthalmic solution. A double-blind randomized controlled trial was conducted. Swabs were taken from the inferior fornix conjunctiva of the right eyes of 60 newborns 1 hour after birth. Either the 2.5% povidone-iodine ophthalmic solution or the 1% chloramphenicol eye ointment was randomly applied to the conjunctivae. Conjunctival swabs were taken 2 hours after prophylaxis treatment. Specimens were delivered to the Microbiology Laboratory to determine the number of bacterial colonies and to evaluate bacterial pattern. Sixty eye specimens were included in the study. Bacterial growth was shown in 44 eye specimens, whereas it was not found in the remaining 16 eye specimens. The bacteria found in neonatal conjunctivae was gram-positive coccus (61%), followed by gram-positive bacillus (36%) and gram-negative bacillus (2%). Both agents significantly reduced the bacterial colony-forming unit (P = 0.00); however, the effect was not significantly different as shown by statistics between both groups (P = 0.748), indicating that the 2.5% povidone-iodine ophthalmic solution had a similar effect to the 1% chloramphenicol eye ointment. No adverse effect such as toxic conjunctivitis or corneal haziness was found in both groups. The 2.5% povidone-iodine ophthalmic solution has been proven as effective as the 1% chloramphenicol eye ointment and induces no toxic reaction. Because it is less expensive than the other, it could be recommended as a good alternative for ophthalmia neonatorum prophylaxis. Further studies with a larger sample size should be conducted to confirm its cost-effectiveness.

Effect of diquafosol ophthalmic solution on the optical quality of the eyes in patients with aqueous-deficient dry eye.

Science.gov (United States)

Koh, Shizuka; Maeda, Naoyuki; Ikeda, Chikako; Oie, Yoshinori; Soma, Takeshi; Tsujikawa, Motokazu; Watanabe, Hitoshi; Nishida, Kohji

2014-12-01

To investigate the short- and long-term effects of diquafosol ophthalmic solution on the optical quality of the eyes in patients with aqueous-deficient dry eye. Sixteen eyes in 16 patients with mild or moderate aqueous-deficient dry eye were treated with 3% diquafosol ophthalmic solution. Ocular higher-order aberrations (HOAs) were measured with a wavefront sensor before and at 15 min after diquafosol instillation at the baseline visit and at 4 weeks after treatment initiation. Dry eye symptoms, tear break-up time (BUT), corneal/conjunctival fluorescein staining and Schirmer's test were also evaluated before and after treatment with diquafosol. Treatment with diquafosol ophthalmic solution significantly improved dry eye symptoms, corneal staining and BUT. Compared with mean total HOAs at baseline (0.180 ± 0.06 μm), those at 4 weeks after treatment significantly decreased (0.148 ± 0.039 μm; p = 0.035), whereas those 15 min after diquafosol instillation at the baseline visit did not change significantly (0.170 ± 0.049 μm; p = 0.279). Although no significant change in HOAs was observed as a short-term effect of a single-drop instillation of diquafosol, long-term use of diquafosol to treat aqueous-deficient dry eye reduced HOAs as well as improved corneal epithelial damage and tear film stability. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore.

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Gong, Lan; Sun, Xinghuai; Ma, Zhizhong; Wang, Qinmei; Xu, Xun; Chen, Xiaoming; Shao, Yan; Yao, Ke; Tang, Luosheng; Gu, Yangshun; Yuan, Huiping; Chua, Wei Han; Chuan, Jacob Cheng Yen; Tong, Louis

2015-07-01

To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore. A total of 497 patients with dry eye (Schirmer's test, 5 mm; fluorescein and RB score, 3 points) from China and Singapore were randomised to receive either diquafosol ophthalmic solution (diquafosol) or sodium hyaluronate ophthalmic solution (HA) at 1:1 ratio. The fluorescein staining scores and rose bengal (RB) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4 weeks after start of treatment. In the diquafosol group, changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.1±1.5 and -2.5±2.0, respectively. Compared with the HA group, changes in fluorescein score were non-inferior and changes in RB score were superior (p=0.019). In addition, diquafosol and HA improved tear film breakup time by 1.046±1.797 and 0.832±1.775 s, respectively (no significant intergroup difference). Adverse event onset rates were 16.3% (40 of 246 subjects) and 10.0% (25 of 251 subjects) in the diquafosol group and HA group, respectively, with borderline significant intergroup differences (p=0.046), while adverse drug reaction incidence rates were 12.2% (30 of 246 subjects) and 6.0% (15 of 251 subjects), respectively (p=0.019). Only mild adverse drug reactions (>2%) in the form of eye discharge, itching or irritation were observed. Diquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA. NCT01101984. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Optimising concentrations of antimicrobial agents in pharmaceutical preparations: Case of an oral solution of glycerol and an ophthalmic solution containing cysteamine.

Science.gov (United States)

Chan Hew Wai, A; Becasse, P; Tworski, S; Pradeau, D; Planas, V

2014-11-01

In the context of current distrust of antimicrobial preservatives, the quantities of these substances in two pharmaceutical formulas were studied: an ophthalmic solution of cysteamine preserved benzalkonium chloride at 1mg/5mL and Glycerotone(®) preserved with sorbic acid at 0.1g/100g. The purpose of this work was to verify that a reduction of the quantities of preservative continues to fulfil the requirements for antimicrobial preservation. The Test of efficacy of antimicrobial preservation, section 5.1.3 of the 8th edition of the European Pharmacopoeia, was carried out on each formulation prepared with decreasing quantities of preservative. The results show that formulations whose preservative concentration was reduced by a factor of four remained compliant with standards. It is to be noted that in formulas without preservative, fungal growth was observed in both the solution of Glycerotone(®) and the ophthalmic solution containing cysteamine. Although there is no question that an antimicrobial preservative is necessary, the quantity of preservative can be reduced without deteriorating the quality of the pharmaceutical product but the minimal effective concentration remains to be determined. The formulations of many pharmaceutical products should therefore be examined in order to limit the quantities of preservative while continuing to guarantee patient's safety. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system

OpenAIRE

Ryan, Gerard; Fain, Joel M; Lovelace, Cherie; Gelotte, Karl M

2011-01-01

Abstract Background Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimi...

Ocular pharmacokinetics comparison between 0.2% olopatadine and 0.77% olopatadine hydrochloride ophthalmic solutions administered to male New Zealand white rabbits.

Science.gov (United States)

Iyer, Ganesh R; Cason, Marita M; Womble, Scott W; Li, Guangming; Chastain, James E

2015-05-01

The primary objective of this study was to compare uptake and distribution of the commercially available formulation of 0.2% olopatadine and the newly developed 0.77% olopatadine hydrochloride ophthalmic solution formulation with improved solubility following a single (30 μL), bilateral topical ocular dose in male New Zealand white rabbits. Each animal received a single 30-μL topical ocular dose (0.2% olopatadine or 0.77% olopatadine hydrochloride ophthalmic solution) to the right (OD) eye followed by the left (OS) eye for a total dose of 60 μL. Olopatadine concentrations were measured in ocular tissues (cornea, bulbar, conjunctiva, choroid, iris-ciliary body, whole lens, retina), aqueous humor, and plasma at prespecified time points over 24 h using a qualified liquid chromatography coupled with mass spectrometry (LC-MS/MS) analytical method. Olopatadine was absorbed into the eye and reached maximal levels (Cmax) within 30 min (0.5 h) to 2 h (Tmax) in ocular tissues and plasma for both treatment groups, except for the lens in which the Tmax was 4 h in the 0.2% olopatadine group and 8 h in the 0.77% olopatadine hydrochloride group, respectively. Tissues associated with the site of dosing, that is, the conjunctiva and cornea, had the highest concentrations of olopatadine in both the 0.2% olopatadine (609 and 720 ng/g) and 0.77% olopatadine hydrochloride (3,000 and 2,230 ng/g) dose groups. The greatest differences between 0.2% olopatadine and 0.77% olopatadine hydrochloride were associated with the overall duration and level of ocular exposures. The newly developed 0.77% olopatadine hydrochloride ophthalmic solution formulation resulted in a higher and more prolonged olopatadine concentration in the target tissue, that is, conjunctiva compared to the commercial formulation of 0.2% olopatadine ophthalmic solution.

76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-05-24

... committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed...] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and...

Reduced in vivo ocular surface toxicity with polyquad-preserved travoprost versus benzalkonium-preserved travoprost or latanoprost ophthalmic solutions.

Science.gov (United States)

Liang, Hong; Brignole-Baudouin, Françoise; Riancho, Luisa; Baudouin, Christophe

2012-01-01

The study used a validated acute in vivo model to compare a new formulation of travoprost 0.004% ophthalmic solution(travoprost PQ), preserved with polyquaternium-1 (PQ), with commercially available formulations of benzalkonium-chloride(BAK)-preserved travoprost 0.004% ophthalmic solution(travoprost BAK) and BAK-preserved latanoprost 0.005%ophthalmic solution (latanoprost BAK). Adult male New Zealand albino rabbits (n = 36) were randomly divided into 6 groups. Phosphate-buffered saline (PBS), 0.001% PQ, 0.015% BAK, travoprost PQ, travoprost BAK or latanoprost BAK were applied onto rabbit eyes as 1 drop, for 15 times at 5-min intervals.The ocular surface reactions were investigated at hour 4 and day 1 using slitlamp examination; in vivo confocal microscopy (IVCM) for cornea, limbus and conjunctiva/conjunctiva-associated lymphoid tissue, conjunctival impression cytology and standard immunohistology in cryosections for detecting CD45+ infiltrating cells and MUC-5AC-labeled cells. PBS, PQ and travoprost PQ did not induce obvious irritation by clinical observation, changes in microstructures of the whole ocular surface as measured by IVCM analysis,inflammatory infiltration or cell damage as measured by impression cytology, altered levels of goblet cell counts or numerous CD45+ cells in the cornea. In contrast, all BAK-containing products induced diffuse conjunctival hyperemia and chemosis, abnormal changes in the ocular surface microstructure,significant total ocular surface toxicity scores,damaged epithelial cells, inflammatory cell infiltration and decreased goblet cell density. Travoprost PQ did not elicitocular surface toxicity when administered to rabbit eyes.These results suggest a greater safety advantage for the ocular surface of patients receiving chronic glaucoma treatment with PQ-preserved drugs.

Severe hyperkalemia as a complication of timolol, a topically applied beta-adrenergic antagonist

International Nuclear Information System (INIS)

Swenson, E.R.

1986-01-01

Severe hyperkalemia occurred in a patient with radiation pneumonitis and glaucoma shortly after beginning prednisone therapy. There was no evidence of renal failure, diabetes, acidosis, increased potassium intake, or significant tissue trauma. Medications having adverse effects on potassium metabolism were considered, and the patient's use of timolol maleate eyedrops was discontinued. His serum potassium level normalized despite continuation of the prednisone therapy. He became hyperkalemic on rechallenge with timolol and normokalemic following its withdrawal. This case indicates that the potential for beta-blocker-induced hyperkalemia exists even with topical appreciation

Effect of diquafosol three per cent ophthalmic solution on tear film and corneal aberrations after cataract surgery.

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Lee, Hun; Kim, Sang Myung; Choi, Seonghee; Seo, Kyoung Yul; Kim, Eung Kweon; Kim, Tae-Im

2017-11-01

The aim was to evaluate the effect of diquafosol on tear film parameters and corneal aberrations after cataract surgery. This retrospective, comparative, observational case series included patients who underwent cataract surgery with or without peri-operative use of diquafosol three per cent ophthalmic solution. Patients in group I (31 eyes) were treated with diquafosol three per cent ophthalmic solution six times a day from one week before surgery to three months after surgery. Patients in group II (33 eyes) underwent cataract surgery without being administered diquafosol. Tear film break-up time (BUT), the ocular surface disease index (OSDI), the Oxford Scheme score, Schirmer's test I and corneal aberrations were determined before and at one and three months post-surgery. In group I, the BUT, OSDI and Oxford Scheme score showed significant improvement at one and three months post-surgery (p = 0.002 for BUT at one month and three months, p = 0.023 and p = 0.049 for OSDI at one month and three months and p = 0.001 and p = 0.026 for Oxford Scheme at one month and three months), compared to baseline. In group II, the BUT, OSDI and Oxford Scheme score did not show any significant improvement during the follow-up period. In both groups, Schirmer's test I significantly decreased at three months post-surgery (p = 0.011 for group I and p = 0.034 for group II), compared to baseline. There were significant differences in the BUT and OSDI between the groups at three months post-surgery (p = 0.037 for BUT and p = 0.011 for OSDI). Regarding the corneal aberration, there were no significant differences between the groups at three months post-surgery. Peri-operative application of diquafosol three per cent ophthalmic solution may prevent dry eye-related ocular surface changes accompanied by improvement of ocular symptom. No definite changes in corneal aberrations were noted. © 2017 Optometry Australia.

Rapid and selective removal of preservative from ophthalmic formulations during eyedrops instillation.

Science.gov (United States)

Hsu, Kuan-Hui; Chauhan, Anuj

2015-11-01

About 70% of eyedrops contain benzalkonium chloride (BAK) as a preservative to prevent the growth of microorganisms. While preservatives are mandated to maintain sterility, many patients exhibit irritation and toxicity to such compounds. We propose to mitigate the ocular toxicity in the ocular formulations without compromising sterility by designing a device that can be incorporated into an eyedrops bottle to selectively remove the preservatives during the process of drop instillation. Here, we specifically focus on macroporous poly(2-hydroxyethyl methacrylate) (pHEMA) gel due to its excellent biocompatibility and high partition coefficient for BAK. In addition to specific selectivity for BAK, the device also requires high hydraulic permeability to allow drop dispensing without excessive pressure drop. The pHEMA monolith can remove nearly 100% of contained BAK from a 25 ml, 0.012% BAK solution with negligible uptake of the hydrophilic drugs such as timolol and dorzolamide. The filter, however, had to be pre-equilibrated with hydrophobic drugs to reach a high separation of BAK without reducing the concentration of the active drug. The average hydraulic permeability of the filter was 0.025 Darcy, which is about 5-fold lower than the ideal value. Incorporation of a pHEMA macroporous gel into an eyedrops bottle can virtually eliminate the exposure of the eyes to the preservatives without compromising the sterility. Our novel design can eliminate the preservative induced toxicity from eyedrops thereby impacting hundreds of millions of patients with chronic ophthalmic diseases such as glaucoma and dry eyes. Copyright © 2015 Elsevier B.V. All rights reserved.

Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.

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Kanda, Yoshiko; Kayama, Tomoko; Okamoto, Shinji; Hashimoto, Masako; Ishida, Chiemi; Yanai, Tomoko; Fukumoto, Mitsuru; Kunihiro, Eiichi

2012-12-01

Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000. This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice. Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.

A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients.

Science.gov (United States)

Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi

2012-10-01

To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. TRIAL DESIGN AND METHODS: In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

A Comparative Summary on Antioxidant-like Actions of Timolol with Other Antioxidants in Diabetic Cardiomyopathy.

Science.gov (United States)

Turan, Belma

2016-01-01

Cellular signaling associated with cardiac β-adrenergic receptors (β-AR) is composed of coupled mechanism among β 1-/β2-AR and Gs proteins with contribution of constitutive β3-AR coupling to Gi proteins. However, down-regulation of β-ARs in the heart under pathological conditions is mediated with a signaling G proteins-included mechanism. Additionally, there are serious conflicting data on this field in literature yet. Although some of these conflictions are generally related with either experimental protocols for different approaches or different animal models. To treat cardiovascular disorders, generally, various types of β-blockers are used while their action mechanisms are not fully known yet. Furthermore, although β-blockers are generally used to block the activated β-ARs, they can be used to scavenge free radicals under oxidative stress. Studies, in whole-system, organ or cellular levels, showed that some β-blockers, including timolol, have protective-actions against increased oxidative stress in diseased heart via ROSscavenging. Additionally, it has been mentioned that some β-blockers nicely prevented the development of heart failure in both experimental and clinical studies by restoring sarcoplasmic reticulum (SR) Ca(2+) release channels, RyR2. Since diabetic cardiomyopathy is recognized due to its diminished responsiveness to β1-AR agonist stimulation in the heart with an up-regulation of β 3-AR, inducing a strong negative inotropic effect on left ventricular function, it has been shown that treatment of streptozotocin-diabetic rats with timolol provided a marked cardio-protection. Importantly, it has been also documented that timolol treatment-dependent cardio-protection in diabetic rats includes basically prevention of RyR2- hyperphosphorylation, which, in turn, block Ca(2+)-leakage from SR via scavenging oxidative agents to control redox-state of cardiomyocytes. This action of timolol in diabetic heart is very similar to other known

Comparative in vitro toxicology study of travoprost polyquad-preserved, travoprost BAK-preserved, and latanoprost BAK-preserved ophthalmic solutions on human conjunctival epithelial cells.

Science.gov (United States)

Brignole-Baudouin, Françoise; Riancho, Luisa; Liang, Hong; Baudouin, Christophe

2011-11-01

To compare the toxicological profile of a new formulation of travoprost 0.004% ophthalmic solution (travoprost PQ), containing the preservative polyquaternium-1(PQ, polyquad), with the commercially available formulation of benzalkonium chloride (BAK)-preserved travoprost 0.004% ophthalmic solution (travoprost BAK) and BAK-preserved latanoprost 0.005% ophthalmic solution (latanoprost BAK). Human conjunctival epithelial cells were incubated with phosphate-buffered saline (PBS), BAK 0.015%, BAK 0.020%, PQ 0.001%, travoprost PQ preserved with PQ 0.001%, travoprost preserved with BAK 0.015%, or latanoprost preserved with BAK 0.020%. Six toxicological assays were used to assess: cell viability (neutral red, Alamar blue), apoptosis (YO-PRO-1, Hoechst 33342), and oxidative stress (H(2)DCF-DA, hydroethidine). Apoptosis and oxidative stress were each reported according to cell viability as observed with neutral red and Alamar blue for a total of 10 analyses per treatment depending on the cell viability test used to interpret apoptosis and oxidative stress responses. There were no significant differences in toxicity between cells exposed to PBS and cells exposed to travoprost PQ (10/10 analyses) or PQ 0.001% (9/10 analyses). Ten out of 10 analyses revealed that travoprost PQ produced significantly less cytotoxicity than latanoprost BAK (p solution in 9 of 10 analyses (p < 0.0001). A panel of in vitro toxicity analyses supports the safety of travoprost PQ. Travoprost PQ may be better for ocular surface health than BAK-preserved formulations of latanoprost or travoprost but clinical studies are required to validate these comparisons.

Degree of corneal anaesthesia after topical application of 0.4% oxybuprocaine hydrochloride and 0.5% proparacaine hydrochloride ophthalmic solution in clinically normal cattle.

Science.gov (United States)

Little, W B; Jean, G St; Sithole, F; Little, E; Jean, K Yvorchuk-St

2016-06-01

The use of corneal anaesthesia is necessary for a range of clinical purposes. Therefore, we assessed and compared the efficacy of corneal anaesthesia after application of 0.4% oxybuprocaine hydrochloride and 0.5% proparacaine hydrochloride ophthalmic solution in clinically normal cattle. The 24 clinically normal cows were allocated into two groups. Cows in group 1 (n = 12) received 0.2 mL of 0.4% oxybuprocaine hydrochloride with fluorescein ophthalmic solution in one eye and 0.2 mL of sterile saline (0.9% NaCl) with fluorescein in the contralateral eye (control). Group 2 (n = 12) received 0.2 mL of 0.4% oxybuprocaine hydrochloride with fluorescein ophthalmic solution in one eye and 0.2 mL of 0.5% proparacaine hydrochloride with fluorescein in the contralateral eye (control). In each group, corneal touch threshold was determined by Cochet-Bonnet aesthesiometer for both eyes immediately prior to topical administration of solutions, at 1 min and 5 min after administration of topical solutions and every 5 min thereafter for a total of 75 min. Significant corneal anaesthesia was noted immediately following topical application of both oxybuprocaine and proparacaine as compared with controls, with maximal corneal anaesthesia noted 1 min after administration. Both oxybuprocaine and proparacaine produced significant corneal anaesthesia for the duration of the 75-min study. Neither oxybuprocaine hydrochloride nor proparacaine hydrochloride treatment resulted in visible adverse effects. There are limited data available demonstrating the efficacy and duration of corneal anaesthetic agents in cattle. Both oxybuprocaine hydrochloride and proparacaine hydrochloride should be considered practical options for providing corneal anaesthesia in cattle in a clinical setting. © 2016 Australian Veterinary Association.

Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives.

Science.gov (United States)

Rojanarata, Theerasak; Tankul, Junlathip; Woranaipinich, Chayanee; Potawanich, Paweena; Plianwong, Samarwadee; Sakulma, Sirinart; Saehuan, Choedchai

2010-10-01

The aim of this study was to investigate the stability of fortified cefazolin sodium ophthalmic solutions (50 mg mL⁻¹) extemporaneously prepared in commercial artificial tears containing 2 different types of preservatives, namely the surfactants and oxidants. Fortified cefazolin sodium solutions were prepared by reconstituting cefazolin for injection with sterile water and further diluted with Tears Naturale II or Natear, 2 commercial artificial tears containing polyquaternium-1 and sodium perborate, respectively, as preservatives. The solutions were then kept at room temperature (28°C) or in the refrigerator (4°C). During the 28-day period, the formulations were periodically examined for the physical appearance, pH, and the remaining drug concentrations. The antibacterial potency was evaluated as the minimal inhibitory concentration against Staphylococcus aureus strain ATCC 29923 by broth dilution technique. The activity of the preservatives was demonstrated by antimicrobial effectiveness tests. On day 28, the microbial contamination in the preparations was tested. The stability profiles of cefazolin solutions prepared in Tears Naturale II, Natear, and water were not different, but they were significantly influenced by the storage temperature. The refrigerated formulations showed no loss of drug and antibacterial potency as well as alteration of physical appearance and pH throughout the 28 days. In contrast, those kept at room temperature showed gradual change in color and odor. The degradation of drug exceeded 10% from day 3 and the decrease of antibacterial potency could be observed at week 3. All cefazolin solutions prepared in artificial tears retained the antimicrobial activity of preservatives and were free from bacterial and fungal contamination throughout the 28-day period of study. Cefazolin sodium ophthalmic solutions can be extemporaneously prepared in Tears Naturale II or Natear without the influence from different types of preservatives used in

Overview of the [corrected] travoprost /timolol BAK-free fixed combination.

Science.gov (United States)

Konstas, Anastasios G P; Quaranta, Luciano; Realini, Tony

2012-04-01

Glaucoma is the second leading cause of blindness globally, representing a significant public health concern. More than 60 million people are affected by glaucoma worldwide; as this population ages, the number is expected to increase. Glaucoma is a collection of heterogeneous diseases sharing common clinical characteristics. The goal of treatment is to prevent significant visual dysfunction through reduction of intraocular pressure (IOP). This is a review of the current literature about combination therapeutic regimens for the reduction of IOP, focusing on the risk : benefit profile of a fixed-combination therapy using travoprost and timolol. Since the debut of prostaglandin analogues in the 1990s, only modest innovation has occurred in glaucoma pharmacology. A growing body of research has established that the preservative benzalkonium chloride (BAK) might not be the benign contributor expected of excipient ingredients. Thus, BAK-free treatments were developed, with the goal of IOP reduction without furthering ocular surface disease symptoms. The BAK-free travoprost/timolol combination represents an important addition to glaucoma medication options and may fill an unmet need in this therapeutic arena.

Preservative-free tafluprost/timolol fixed combination: a new opportunity in the treatment of glaucoma.

Science.gov (United States)

Konstas, Anastasios G P; Holló, Gabor

2016-06-01

Medical therapy of glaucoma aims to maintain the patient's visual function and quality of life. This generally commences with monotherapy, but it is often difficult to reach the predetermined target pressure with this approach. Fixed combinations (FCs) are therefore selected as the next step of the medical therapy algorithm. By employing a prostaglandin/timolol fixed combination (PTFC) the desired target 24-hour intraocular pressure can be reached in many glaucoma patients with the convenience of once-a-day administration and the associated high rate of adherence. The current role and value of FCs in the medical therapy of glaucoma is critically appraised. Special attention is paid to the PTFCs and the emerging role of preservative-free PTFCs. This review summarizes existing information on the efficacy and tolerability of the new preservative-free tafluprost/timolol FC (Taptiqom®). The preservative-free tafluprost/timolol FC represents a promising stepwise treatment option for those patients whose intraocular pressure is insufficiently controlled with available monotherapy options. This novel FC has the potential to substantially improve glaucoma management and through evolution of the current glaucoma treatment paradigm, to become a core therapeutic option in the future. Nonetheless, future research is needed to better delineate the therapeutic role of current and future preservative-free FCs in glaucoma therapy.

Gatifloxacin Ophthalmic Solution for Treatment of Bacterial Conjunctivitis: Safety, Efficacy and Patient Perspective

OpenAIRE

Clyde Schultz

2012-01-01

Gatifloxacin is a fourth generation fluroquinolone antibiotic that has been prescribed for systemic use. However, the drug which was developed by Kyorin (Japan) was linked to toxic reactions and death and was banned in the United States and Canada for use as an oral dosage form. It continues to be used as a topical application for ophthalmic conditions as the systemic toxicity seen when taking the drug orally has not been observed with ophthalmic use. The available data indicate that ocular u...

Observation on the availability and tolerance of 0.1% bromfenac sodium hydrate ophthalmic solution in the partial substitution of glucocorticoid after LASEK

Directory of Open Access Journals (Sweden)

Zhi-Hui Deng

2015-12-01

Full Text Available AIM:To observe the availability and tolerance of 0.1% bromfenac sodium hydrate ophthalmic solution in the partial substitution of glucocorticoid after laser subepithelial keratomileusis(LASEK. METHODS:Totally 180 patients(180 eyesreceived LASEK were selected and divided into study group and control group according to different medications. The study group adopted 0.1% bromfenac sodium hydrate ophthalmic solution combined with glucocorticoid; the control group adopted glucocorticoid. The changes of visual acuity and intraocular pressure(IOPof two groups were recorded before and after surgery and the occurrence of diffuse larnellar kerafitis(DLKafter surgery were observed. RESULTS:After 1mo of surgery, visual acuity of study group was 1.25±0.22 while that of control group was 0.97±0.23(PP>0.05. After 1 and 3mo of surgery, IOP of study group was 12.29±2.71 and 12.67±2.33mmHg while that of control group was 14.26±2.65 and 14.56±2.61mmHg, the difference was statistically significant(PP>0.05. In terms of tolerance, the control group had 4 cases(4 eyestaking the IOP-lowering medication. The study group had no uncomfortable cases. The DLK level of the study group at 0, 1, 2 was 93.33%, 6.67%, 0%, respectively and those in control group was 75.56%, 17.78% and 6.67%, respectively, and the differences were significant(PCONCLUSION:0.1% bromfenac sodium hydrate ophthalmic solution can efficiently stabilize the patient's IOP after LASEK. The patient has a better visual acuity, visual function and fewer complications. The tolerance is also favorable. It is worthy of promotion.

Comparison of evening and morning dosing of travoprost 0.004%/timolol 0.5% fixed combination in 6 month period.

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Suić, Smiljka Popović; Laus, Katia Novak; Dosen, Vukosava Maricic; Ekert, Miroslav; Mandić, Zdravko; Bojić, Lovro

2010-09-01

An open label, multi-center, 6 months observational study of new fixed combination (travoprost 0.004%/timolol 0.5%), in order to evaluate both efficacy (intraocular pressure lowering) and tolerability (patient and investigator satisfaction) of two dosing regimens--evening (PM) and morning (AM). After screening for enrollment, to 40 patients (79 eyes with primary open angle glaucoma or ocular hypertension), new fixed combination travoprost 0.004%/timolol 0.5% was prescribed once a day in the evening (PM). Patients were enrolled according to each investigator decision on indication for travoprost 0.004%/timolol 0.5% fixed combination once a day, without washout period after previous medication. Intraocular pressure was measured at 9 AM at all time control points: at baseline, after 1 month, after 3 months and after 6 month. After 1 month, screening for nonresponders (criteria: 20% intraocular pressure lowering) and subjects with major side effects was performed. At second control visit, after 3 months PM dosing, intraocular pressure was measured and patients were instructed to continue once a day the same medication, but in the morning (AM) for consequent 3 months. After 1 month, reduction in mean intraocular pressure value was 21.66%. At the visit after 3 month, the mean intraocular pressure was 15.67 +/- 2.17 mm Hg (reduction 21.14%). 3 month after dosing regimen changed to AM (6 month after beginning of travoprost 0.004%/timolol 0.5% combination therapy), reduction in intraocular pressure value was 19.86%. The differences (mean +/- standard deviation) in intraocular pressure values after 1, 3 and 6 month were all highly statistically significant compared to baseline values. The tolerability was evaluated in five steps (Likert scale) ranging from unsatisfactory to excellent by both patient and investigator--taken at 3 and 6 month control visit. 95% of patients and 100% of investigators were satisfied with the possibility of choosing dosing regimen for travoprost 0

[Safety and efficacy of a new preservative-free levocabastine ophthalmic solution (Levofree®) using the conjunctival provocation test].

Science.gov (United States)

Allaire, C; Siou-Mermet, R; Bassols, A

2012-09-01

To evaluate the safety and efficacy of preservative-free levocabastine 0.05 % ophthalmic solution compared to placebo (vehicle) and to preserved levocabastine 0.05 % ophthalmic suspension in the prevention of allergic conjunctivitis induced by a conjunctival provocation test. Ninety-two subjects (18-50 years) with a previous history of allergic conjunctivitis to pollen were randomised to receive either preservative-free levocabastine solution in one eye and preserved levocabastine suspension in the fellow eye (n=69), or preservative-free levocabastine in one eye and placebo in the fellow eye (n=23). One drop of each product was administered 10 minutes (visit 3) and 4 hours (visit 4) prior to the provocation test. The primary efficacy criterion was the sum of the itching and conjunctival hyperemia scores assessed at 3, 5 and 10 minutes after the provocation test. The safety evaluation included adverse events, visual acuity, intra-ocular pressure and study drug drop sensation. The efficacy of the preservative-free solution was significantly higher than that of placebo at all time points (P≤0.01) with one exception at visit 4 (3 minutes after the provocation test). It was significantly higher than that of the preserved suspension at visit 3, and equivalent at visit 4. The incidence of adverse events was lower with the preservative-free solution than with the preserved suspension. 94.2 % and 95.7 % subjects rated preservative-free levocabastine drop sensation as "good" or "very good" at visits 3 and 4 respectively, whereas these rates were 68.1 % and 63.8 % with preserved levocabastine. This difference between the two formulations was highly statistically significant (Ppreservative-free levocabastine was superior to that of the placebo and of the preserved suspension at visit 3, at least as effective as the preserved suspension at visit 4, and better tolerated at each visit. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

In vivo confocal microscopy of conjunctiva in preservative-free timolol 0.1% gel formulation therapy for glaucoma.

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Frezzotti, Paolo; Fogagnolo, Paolo; Haka, Gentiana; Motolese, Ilaria; Iester, Michele; Bagaglia, Simone A; Mittica, Pietro; Menicacci, Cristina; Rossetti, Luca; Motolese, Eduardo

2014-03-01

To evaluate the effects at 1 year of preservative-free timolol gel and preserved timolol eye drops on conjunctiva and tear parameters. Forty patients with primary open-angle glaucoma or ocular hypertension were randomized to the two treatment groups and compared with 20 healthy age-matched controls. Clinical tests (IOP, Schirmer I test, and lacrimal film break-up time BUT) and in vivo conjunctival confocal microscopy (IVCM) were performed in all patients at baseline and after 12 months. IVCM (HRT II Rostock Cornea Module; Heidelberg Engineering GmbH, Heidelberg, Germany) was performed after topical anaesthesia in the four cardinal locations and at the corresponding limbus to analyse conjunctiva cells. The main IVCM outcomes were goblet cell density and epithelial regularity. IVCM and clinical parameters were similar in the three groups at baseline. After 12 months, intra-epithelial goblet cell density was significantly lower in the preserved (48.25 ± 7.70) than in the preservative-free beta-blocker group (86.83 ± 22.17, p preserved beta-blocker medication group than in the preservative-free beta-blocker group (p preserved timolol (respectively, 11.3 ± 2.97 and 8.12 ± 0.99) compared with preservative-free timolol (16.8 ± 1.83 and 11.27 ± 1.27, p preservative-free beta-blocker gel induces less changes at ocular surface than preserved beta-blockers, a fact that should be considered to obtain less adverse effects and maximal adherence to treatment in a chronic condition such as glaucoma. © 2013 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution

OpenAIRE

Cho, Hyung; Wolf, Kenneth J; Wolf, Eric J

2009-01-01

Hyung Cho1, Kenneth J Wolf1, Eric J Wolf21Department of Ophthalmology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA; 2Department of Ophthalmology, Edward S. Harkness Eye Institute of Columbia University College of Physicians and Surgeons, New York, NY, USAAbstract: Recently, several new ophthalmic NSAID products have been introduced for commercial use in the United States. The purpose of this review is to briefly overview the ophthalmic NSAIDs currently...

Gatifloxacin Ophthalmic Solution for Treatment of Bacterial Conjunctivitis: Safety, Efficacy and Patient Perspective

Directory of Open Access Journals (Sweden)

Clyde Schultz

2012-01-01

Full Text Available Gatifloxacin is a fourth generation fluroquinolone antibiotic that has been prescribed for systemic use. However, the drug which was developed by Kyorin (Japan was linked to toxic reactions and death and was banned in the United States and Canada for use as an oral dosage form. It continues to be used as a topical application for ophthalmic conditions as the systemic toxicity seen when taking the drug orally has not been observed with ophthalmic use. The available data indicate that ocular use of gatifloxacin is safe, and effective against a broad spectrum of bacteria, including intracellular bacteria and anaerobes.

Latanoprost ophthalmic solution in the treatment of open angle glaucoma or raised intraocular pressure: a review

Directory of Open Access Journals (Sweden)

Andrea Russo

2009-01-01

Full Text Available Andrea Russo, Ivano Riva, Teodoro Pizzolante, Federico Noto, Luciano QuarantaCattedra di Malattie dell’Apparato Visivo, Università degli studi di Brescia, USVD “Centro per lo studio del Glaucoma” Spedali Civili di BresciaAbstract: Latanoprost is a prostaglandin F2-alpha isopropyl ester prodrug which is rapidly hydrolyzed by esterases in the cornea to the biologically active latanoprost acid. When latanoprost is topically administered into the eye, the cornea seems to act like as a slow-release depot to the anterior segment. One hour after administration maximum concentration is found in the iris, followed by the anterior chamber and the ciliary body. Despite extensive research, controversy remains about the real mechanism of action of this drug. Immunohistochemical data have shown that the intraocular pressure (IOP reduction with topical prostaglandin F2-alpha is associated with a reduction of collagens within the uveoscleral outflow pathway. Evidence from several experimental and clinical studies suggests that latanoprost is a valuable addition first-line treatment alternatives for glaucoma, ocular hypertension and even angle-closure glaucoma. Strong points are its efficacy, which is demonstrated to be higher than that of brimonidine, dorzolamide and timolol with fewer systemic adverse effects; a convenient administration schedule; and the IOP-controlling pattern, which is relatively flat compared with timolol and dorzolamide, and enables better control in glaucoma progression, since large fluctuations may be associated with the risk of developing glaucoma in untreated ocular hypertensive subjects.Keywords: latanoprost, intraocular pressure, glaucoma, ocular hypertension

Effects of Diquafosol Ophthalmic Solution on Quality of Life in Dry Eye Assessed Using the Dry Eye-Related Quality-of-Life Score Questionnaire: Effectiveness in Patients While Reading and Using Visual Display Terminals.

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Utsunomiya, Tsugiaki; Kawahara, Atsushi; Hanada, Kazuomi; Yoshida, Akitoshi

2017-08-01

Diquafosol ophthalmic solution improves objective findings in the ocular surface and subjective symptoms in patients with dry eye. The Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire was developed to assess dry eye symptoms and their effects on quality of life. However, because little research using the DEQS has been reported, we evaluated the effects of diquafosol ophthalmic solution on ocular surface findings and quality of life using the DEQS in patients with dry eye. Sixty-three patients with dry eye were assigned to the control group (artificial tears) or diquafosol group. Both groups instilled 1 drop of the solution in both eyes 6 times daily and were evaluated after 2 weeks; the diquafosol group also was instructed to be examined at 1 and 3 months. We evaluated the subjective symptoms using the DEQS, fluorescein staining score, tear film breakup time (BUT), Schirmer testing, and lower tear meniscus height with anterior-segment optical coherence tomography. In the diquafosol group, the fluorescein staining score, BUT, tear meniscus height, and DEQS scores improved significantly compared with before treatment in contrast to the control group. Furthermore, in the diquafosol group, the staining score and BUT improved significantly compared with the control group. Analysis of each DEQS item indicated that diquafosol ophthalmic solution relieved foreign body sensation and problems when reading and using visual display terminals compared with the control group. Diquafosol ophthalmic solution was effective in patients with dry eye, especially those with foreign body sensation and problems when reading and using visual display terminals.

Effects of benzalkonium chloride- or polyquad-preserved fixed combination glaucoma medications on human trabecular meshwork cells.

Science.gov (United States)

Ammar, David A; Kahook, Malik Y

2011-01-01

We investigated the potential short and long-term effects in cultured human trabecular meshwork (TM) cells of various topical glaucoma formulations containing different preservatives. We tested the fixed combination medications 0.004% travoprost plus 0.5% timolol preserved with either 0.015% benzalkonium chloride (BAK; DuoTrav®), or with 0.001% polyquad (PQ; DuoTrav(®) BAK-free); and 0.005% latanoprost plus 0.5% timolol preserved with 0.020% BAK (Xalacom(®)). Also tested was a range of BAK concentrations (0.001%-0.020%) in balanced salt solution (BSS). Cells were treated for 25 min at 37 °C with solutions diluted 1:10 and 1:100 to mimic the reduced penetration of topical preparations to the anterior chamber. The percentage of live cells was determined immediately after treatment through the uptake of the fluorescent vital dye calcein-AM. To determine any long-term effects, we assayed release of matrix metalloproteinase 9 (MMP-9) and apoptosis 24 h after treatments. BAK demonstrated a dose-dependent reduction in TM cell viability, ranging from 71±5% live cells at 0.001% BAK (diluted 1:10) to 33±3% live cells at 0.020% BAK (diluted 1:10). Travoprost (0.004%) plus 0.5% timolol preserved with 0.015% BAK had statistically fewer live TM cells (79±7%) than the same preparation preserved with 0.001% polyquad® (PQ; 93±1%; p<0.001). Latanoprost plus timolol preserved with 0.020% BAK (29±9% live cells) was similar to the 0.020% BAK (33±3%) treatment. However, travoprost plus timolol preserved in 0.015% BAK had significantly more live cells (83±12%) than the 1:10 dilution of 0.015% BAK (49±10%). We also found 0.020% BAK (diluted 1:100) resulted in elevated levels of extracellular MMP-9 at 24 h. These results demonstrate that the substitution of the preservative BAK from topical ophthalmic drugs results in greater in vitro viability of TM cells. Travoprost with timolol, but not latanoprost with timolol, countered some of the toxic BAK effects. BAK treatment

Efficacy and safety of latanoprost versus timolol for primary open angle glaucoma and ocular hypertension: a Meta-analysis

Directory of Open Access Journals (Sweden)

Yang-Yang Wu

2014-03-01

Full Text Available AIM: To evaluate the efficacy and safety of latanoprost versus timolol for primary open angle glaucoma(POAGand ocular hypertension(OHT.METHODS: This was an evidence-based medicine science study. Pertinent studies of randomized controlled trial(RCTwere identified through searches of PubMed, Medline, CNKI and China Biology Medicine disc. The intensive searching by hand and internet was also designed. According to inclusion and exclusion criteria, the study object was limited. Quality of literatures were evaluated by experienced researchers according to the Jadad Score. RevMan 5.0 offered by Cochrane was used for Meta-analysis aimed at the ratio of low intraocular tension and adverse drug reaction.RESULTS: A total of 9 RCT sadded up to 555 patients were involved. The results of meta-analysis showed that, athe difference at 2, 6, 12wk both had statistical significance, latanoprost showed greater intraocular pressure(IOPlowering efficacy compared with timolol. The weighted mean difference(WMDat 2, 6, 12wk was respectively \\〖-0.76, 95% CI(-1.32 to -0.20\\〗, \\〖-1.15, 95% CI(-1.68 to 0.63\\〗 and \\〖-1.01, 95% CI(-1.42 to -0.61\\〗. bThe difference in conjunctival congestion(OR=2.25, 95% CI 0.99 to 5.08and foreign body sensation(OR=2.48, 95% CI 1.02 to 6.03 between latanoprost and timolol group was not statistically significant. CONCLUSION: Latanoprost showed greater IOP lowering efficacy at 12wk compared with timolol for OAG and OH patients. The conjunctival hyperemia, foreign body sensation, iris pigmentation deepened, vision damage of latanoprost group at 12wk compared with timolol, the difference was not significant. This conclusion is not powerful enough in proof due to the medium methodology quality of the included studies, so a large number of high-quality RCTs with large sample are needed for objectively, precisely and entirely evaluating the efficacy.

Development and Evaluation of Diclofenac Sodium Loaded-N-Trimethyl Chitosan Nanoparticles for Ophthalmic Use.

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Asasutjarit, Rathapon; Theerachayanan, Thitaree; Kewsuwan, Prartana; Veeranodha, Sukitaya; Fuongfuchat, Asira; Ritthidej, Garnpimol C

2015-10-01

The ophthalmic preparation of diclofenac sodium (DC) for relieving ocular inflammation is presently available in the market only as an eye drop solution. Due to its low occular bioavailability, it requires frequent application leading to low patients' compliance and quality of life. This study was conducted to develop formulations of DC loaded-N-trimethyl chitosan nanoparticles (DC-TMCNs) for ophthalmic use to improve ocular biavailabiltiy of DC. DC-TMCNs varied in formulation compositions were prepared using ionic gelation technique and evaluated for their physicochemical properties, drug release, eye irritation potential, and ophthalmic absorption of diclofenac sodium. N-Trimethyl chitosan (TMC) with a 49.8% degree of quaternization was synthesized and used for DC-TMCNs production. The obtained DC-TMCNs had particle size in a range of 130-190 nm with zeta potential values of +4 to +9 mV and drug entrapment efficiencies of more than 70% depending on the content of TMC and sodium tripolyphosphate (TPP). The optimized DC-TMCNs formulation contained TMC, DC, and TPP at a weight ratio of TMC/DC/TPP = 3:1:1. Their lyophilized product reconstituted with phosphate buffer solution pH 5.5 possessed a drug release pattern that fitted within the zero-order model. The eye irritation tests showed that DC-TMCNs were safe for ophthalmic use. The in vivo ophthalmic drug absorption study performed on rabbits indicated that DC-TMCNs could improve ophthalmic bioavailability of DC. Results of this study suggested that DC-TMCNs had potential for use as an alternative to conventional DC eye drops for ophthalmic inflammation treatment.

Review of moxifloxacin hydrochloride ophthalmic solution in the treatment of bacterial eye infections

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Darlene Miller

2008-03-01

Full Text Available Darlene MillerAbrams Ocular Microbiology Laboratory, Bascom Palmer Eye Institute, Anne Bates Leach Eye Hospital, Miller School of Medicine-University of Miami, FL, USAAbstract: Moxifloxacin hydrochloride ophthalmic solution 0.5% (Vigamox® is the ocular formulation/adaptation of moxifloxacin. Moxifloxacin is a broad spectrum 8-methoxyfluoroquinolone which terminates bacterial growth by binding to DNA gyrase (topoisomerase II and topoisomerase IV, essential bacterial enzymes involved in the replication, translation, repair and recombination of deoxyribonucleic acid. Affinity for both enzymes improves potency and reduces the probability of selecting resistant bacterial subpopulations. Vigamox is a bactericidal, concentration dependent, anti-infective. It is preservative free, and well tolerated with minimal ocular side effects. It provides increased penetration into ocular tissues and fluids with improved activity against Streptococci and Staphylococci species and moderate to excellent activity against clinically relevant, gram- negative ocular pathogens.Keywords: moxifloxacin, vigamox, pharmacodynamic indices, minimal inhibitory concentrations

SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE SODIUM PHOSPHATE IN BULK AND IN OPHTHALMIC SOLUTION BY RP- HPLC

OpenAIRE

DHUMAL, D. M; SHIRKHEDKAR, A. A; NERKAR, P. P; SURANA, S. J

2012-01-01

A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for simultaneous estimation of Moxifloxacin Hydrochloride (MOX) and Dexamethasone Sodium Phosphate (DSP) in Ophthalmic Solution. The method was carried out on a Qualisil RP C-8 (250 mm x 4.6 mm, 5 µm) column with a mobile phase consisting of Methanol: Water (75:25 v/v) pH adjusted to 3.0 with ortho-phosphoric acid of aqueous phase and flow rate of 1.0 mL min¹. Detection was carried out at 240 nm. The...

Short-term effect of latanoprost and timolol eye drops on tear fluid and the ocular surface in patients with primary open-angle glaucoma and ocular hypertension

DEFF Research Database (Denmark)

Thygesen, John; Aaen, Kim; Theodorsen, F.

2000-01-01

ophthalmology, open-angle glaucoma, ocular hypertension, glaucoma therapy, latanoprost, timolol, Rose-Bengal test, break-up time, Schirmer-1-test, conjunctival impression cytology......ophthalmology, open-angle glaucoma, ocular hypertension, glaucoma therapy, latanoprost, timolol, Rose-Bengal test, break-up time, Schirmer-1-test, conjunctival impression cytology...

Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial

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Toshida H

2017-06-01

Full Text Available Hiroshi Toshida,1 Toshinari Funaki,2 Koichi Ono,3 Nobuhito Tabuchi,4 Sota Watanabe,4 Tamotsu Seki,5 Hiroshi Otake,6 Takuji Kato,7 Nobuyuki Ebihara,8 Akira Murakami2 1Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka, 2Department of Ophthalmology, Juntendo University Graduate School of Medicine, 3Department of Ophthalmology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, 4Pharmaceutical Research Laboratories, Lion Corporation, Kanagawa, 5Tamagawa Eye Clinic, Tokyo, 6Otake Eye Clinic, Kanagawa, 7Kato Eye Clinic, Tokyo, 8Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan Purpose: The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal ophthalmic solution (500 IU/mL for the treatment of patients with dry eye. Patients and methods: This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1 into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. Results: In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (P<0.05 and P<0.01, respectively. Furthermore, the fluorescein clearance rate (fluorescein staining score was significantly higher in the VApal group at 4 weeks (P<0.05. The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks (P<0.01 and P<0.05, respectively, and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week (P<0.05. In before- and after-intervention comparisons, the

Clinical use of gatifloxacin ophthalmic solution for treatment of bacterial conjunctivitis

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Cervantes LJ

2011-04-01

Full Text Available Lorenzo J Cervantes, Francis S MahDepartment of Ophthalmology, Cornea and External Disease, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USAAbstract: Bacterial conjunctivitis is a common infectious disease of the eye, characterized by conjunctival hyperemia, eyelid edema, and purulent discharge. Although the prevalence and incidence are not well reported, bacterial conjunctivitis represents one of the most frequent causes of patient visits to both primary care physicians and ophthalmologists. Most cases of nongonococcal and nonchlamydial bacterial conjunctivitis are self-limiting and may resolve without intervention. There is a place for treatment, however, which allows for a shorter time to clinical and microbiological resolution which may decrease the mild morbidity, decrease health care costs of visits and potential complications, return patients back to school or the work force, and limit the potential spread of this communicable infection. Gatifloxacin ophthalmic solution is a broad spectrum 8-methoxyfluroroquinolone bactericidal antibiotic, with good activity against Staphylococcus aureus, Streptococcus species, and Gram-negative pathogens. It also has a relatively good resistance profile, making it a more than adequate choice in the treatment of bacterial conjunctivitis when therapy is warranted.Keywords: gatifloxacin, Zymar®, Zymaxid®, bacterial conjunctivitis

Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy.

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Kitazawa, Y; Smith, P; Sasaki, N; Kotake, S; Bae, K; Iwamoto, Y

2011-09-01

The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. In this prospective randomized controlled trial, subjects with IOP of at least 22  mm Hg in one or both eyes at 0900  h, and IOP of at least 21  mm Hg in one or both eyes at 1100  h and 1600  h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900  h) for 6 weeks. IOP was assessed at 0900  h, 1100  h, and 1600  h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Mean IOP reduction across all visits and time points was 8.0  mm Hg in the TRA/TIM BAK-free group and 8.4  mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7  mm Hg across visits and time points, with a mean pooled difference of 0.4  mm Hg (95% CI: -0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.

21 CFR 886.4790 - Ophthalmic sponge.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic sponge. 886.4790 Section 886.4790 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4790 Ophthalmic sponge. (a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton...

In vitro testing of thiolated poly(aspartic acid) from ophthalmic formulation aspects.

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Budai-Szű Cs, Mária; Horvát, Gabriella; Gyarmati, Benjámin; Szilágyi, Barnabás Áron; Szilágyi, András; Csihi, Tímea; Berkó, Szilvia; Szabó-Révész, Piroska; Mori, Michela; Sandri, Giuseppina; Bonferoni, Maria Cristina; Caramella, Carla; Csányi, Erzsébet

2016-08-01

Ocular drug delivery formulations must meet anatomical, biopharmaceutical, patient-driven and regulatory requirements. Mucoadhesive polymers can serve as a better alternative to currently available ophthalmic formulations by providing improved bioavailability. If all requirements are addressed, a polymeric formulation resembling the tear film of the eye might be the best solution. The optimum formulation must not have high osmotic activity, should provide appropriate surface tension, pH and refractive index, must be non-toxic and should be transparent and mucoadhesive. We would like to highlight the importance of in vitro polymer testing from a pharmaceutical aspect. We, therefore, carried out physical-chemical investigations to verify the suitability of certain systems for ophthalmic formulations. In this work, in situ gelling, mucoadhesive thiolated poly(aspartic acid)s were tested from ophthalmic formulation aspects. The results of preformulation measurements indicate that these polymers can be used as potential carriers in ophthalmic drug delivery.

21 CFR 886.4390 - Ophthalmic laser.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic laser. 886.4390 Section 886.4390 Food... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4390 Ophthalmic laser. (a) Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin...

Preserved and unpreserved 12 anti-allergic ophthalmic solutions and ocular surface toxicity: in vitro assessment in four cultured corneal and conjunctival epithelial cell lines.

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Ayaki, Masahiko; Iwasawa, Atsuo; Yaguchi, Shigeo; Koide, Ryohei

2010-12-01

In the present study, we evaluated the cytotoxicity of anti-allergic ophthalmic solutions in cultured corneal and conjunctival cells, namely SIRC (rabbit corneal epithelium), BCE C/D-1b (bovine corneal epithelial cells), RC-1 (rabbit corneal epithelium), and Chang (human conjunctival cells). The viability of cell cultures was determined following the exposure of cells to 12 commercially available anti-allergic ophthalmic solutions for varying exposure times and at various dilutions using the MTT and neutral red assays. The cell viability score (CVS) was used to compare the toxicity of different drugs. Based on CVS data, the order of cell viability after exposure to the drugs was Zepelin ≥ Tramelas PF ≥ Cumorol PF ≥ Ketotifen PF ≥ Eyevinal = Fumarton ≥ Cumorol > Intal ≥ Rizaben ≥ Tramelas ≥ Patanol Livostin. In conclusion, cell viability was mostly affected by the concentration of benzalkonium chloride rather than the active component and/or the anti-allergic action of the drug. The CVS was useful in comparing the toxicity of different drugs.

Topical application of timolol decreases the severity and frequency of epistaxis in patients who have previously undergone nasal dermoplasty for hereditary hemorrhagic telangiectasia.

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Ichimura, Keiichi; Kikuchi, Hisashi; Imayoshi, Shoichiro; Dias, Mari Shimada

2016-08-01

Hereditary hemorrhagic telangiectasia (HHT) is widely known to cause bleeding that is difficult to control because of the associated vascular wall fragility. Although nasal dermoplasty results in decreased severity and frequency of nasal bleeding in patients with HHT, it does not eradicate epistaxis because this procedure cannot cover the entire nasal cavity. Residual bleeding warrants additional effective therapy. Preliminary reports on the use of β-adrenergic blockers for treating epistaxis in patients with HHT encouraged us to examine their effects in HHT patients who had previously undergone nasal dermoplasty but still complained of epistaxis. We performed a prospective topical timolol, a nonselective beta blocker, application study involving 12 HHT patients who had undergone nasal dermoplasty. The observation period lasted for 3 months. There was one improperly enrolled case in which timolol administration was discontinued. The mean score of bleeding intensity and that of bleeding frequency were markedly reduced after treatment. Two patients who had required transfusions before treatment did not need them afterward, and patients were generally satisfied with the treatment. Topical timolol application was effective in decreasing epistaxis. Although no adverse effects were observed in the properly selected patients, there are contraindications to timolol application that should be kept in mind when applying this treatment. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Ocular toxicity of beta-blockers and benzalkonium chloride in pigmented rabbits: electrophysiological and morphological studies.

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Chou, A; Hori, S; Takase, M

1985-01-01

Subconjunctival injection of 0.2 ml of the following solutions was carried out once a day for two weeks in the albino and pigmented rabbit: commercial 0.5% timolol or 1% befunolol ophthalmic solutions, both containing benzalkonium chloride, and also these drug solutions containing no preservative, ophthalmic base solutions containing benzalkonium chloride, physiological saline solution or phosphate buffer solution. One week after daily injections of the commercial drug solutions or base solutions with benzalkonium chloride, the electroretinogram (ERG) showed a marked reduction in the a- and b-wave amplitudes in the pigmented rabbit, but the ERG changes were slight in the albino rabbit. After two weeks of injections, histological studies of the pigmented rabbit eyes revealed retinal detachment, visual cell loss and atrophy of the retinal pigment epithelium and choroid; the changes in the albino rabbit eyes were minimal. Injections of the beta-blockers containing no benzalkonium resulted in no significant changes in the ERG or in the tissue structures of all rabbits. Injections of only physiological saline or phosphate buffer had no deleterious effects. Therefore, the ocular toxicity of the beta-blockers was thought to be minor and the toxic effects seen in this study were thought to be due to benzalkonium chloride, which possibly accumulates in the ocular pigments.

Evaluating the efficacy of epinastine ophthalmic solution using a conjunctivitis allergen challenge model in patients with birch pollen allergic conjunctivitis.

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Tagawa, Yoshiaki; Namba, Kenichi; Nakazono, Yumi; Iwata, Daiju; Ishida, Susumu

2017-04-01

The efficacy of epinastine 0.05% ophthalmic solution for pollen allergic conjunctivitis has already been shown in a conjunctival allergen challenge (CAC) test using cedar pollen as a challenge. The present study investigated the efficacy of this solution against birch pollen conjunctivitis in a CAC test. Ten adult subjects (eight males and two females) with asymptomatic birch pollen conjunctivitis were enrolled in this study. The average age of the subjects was 41.1 years. This study was conducted during a period without birch pollen dispersion. In each subject, the epinastine 0.05% ophthalmic solution was instilled in one eye, and an artificial tear fluid was instilled in the fellow eye in a double-blind manner. Five minutes or 4 h after the drug instillation, both eyes were challenged with an optimal concentration of birch pollen, and ocular itching and conjunctival hyperemia were then graded. Tears were collected before the drug instillation and 20 min after the pollen challenge, and the histamine level was measured. The ocular itching scores and palpebral conjunctival hyperemia scores of the epinastine-treated eyes were significantly lower than those of the contralateral control eyes when the eyes were pretreated with the drug 4 h before the CAC. There was a significant correlation between the tear histamine level and mean ocular itching score of three time points (3, 5 and 10 min) following the CAC in the control eyes but not the epinastine-treated eyes. Epinastine is effective in suppressing ocular itching and conjunctival hyperemia in birch pollen conjunctivitis. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

Chick chorioallantoic membrane model for in ovo evaluation of timolol maleate-brimonidine tartrate ocular inserts.

Science.gov (United States)

Ravindran, Vinod Kombath; Repala, Swathi; Subadhra, Sandhya; Appapurapu, Ashok Kumar

2014-06-01

The main aspire of this study was to develop ocular drug delivery system for dual drug glaucoma therapy by timolol maleate-brimonidine tartrate and endeavor the possibility of biocompatibility studies by in ova studies. Matrix type, both hydrophilic and lipophilic polymers, and reservoir-type ocular inserts of timolol maleate were prepared using hydrophilic polymers like polyvinyl alcohol, hydroxyl propyl methyl cellulose K4M and lipophilic polymers like ethylcellulose and eudragit S100 and were optimized. Based on the optimized formulation, triple-layered ocular inserts (reservoir type) of dual drug were prepared by solvent casting technique with an objective of reducing the frequency of administration, obtaining controlled release and greater therapeutic efficacy, preservative free dosage form for the treatment of glaucoma. FTIR spectral studies revealed no pharmaceutical incompatibility and no drug polymer interactions. Maximum drug release (99.18 ± 1.7) was achieved when PVP and HPMC K4M in 1:1 ratio with PEG 400 (0.3 ml) drug reservoir layer was sandwiched between ethyl cellulose as rate control membrane up to 32 h in a controlled fashion. Drug release was by non-Fickian diffusion mechanism for single drug formulation. But in dual drug insert, timolol maleate best fit into zero order and for brimonidine tartrate to Higuchi model and diffusion of drugs from this by non-Fickian diffusion mechanism. In ovo studies suggested that the optimized formulation was found to be sterile, biocompatible and physicochemically stable and support us to claim that the developed formulation was biocompatible.

21 CFR 886.1420 - Ophthalmic lens gauge.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic lens gauge. 886.1420 Section 886.1420...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1420 Ophthalmic lens gauge. (a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a...

Bromfenac ophthalmic solution 0.09 %: human aqueous humor concentration detected by high-performance liquid chromatography.

Science.gov (United States)

Macrì, Angelo; Vagge, Aldo; Salis, Annalisa; Fucile, Carmen; Marini, Valeria; Martelli, Antonietta; Giuffrida, Sebastiano; Iester, Michele; Damonte, Gianluca; Mattioli, Francesca

2017-04-01

The purpose of this study was to evaluate the aqueous humor concentrations of bromfenac ophthalmic solution 0.09 % in patients undergoing phacoemulsification. Patients requiring cataract extraction received one drop (50 µL) of bromfenac 0.09 % solution in the eye to be operated, before bedtime the day before surgery or the morning of the surgery. The last administration was recorded. At the time of paracentesis, an aqueous humor sample was collected with a 30-gauge needle attached to a TB syringe and was later analyzed by high-performance liquid chromatography for drug concentration. 188 treated volunteers and 48 control, untreated, subjects were included in the study. The mean aqueous concentration of bromfenac in the treated group was 37.60 ± 68.86 and 0 nM (nmol/L) in the control group (p < 0.0001). Correlation coefficient in bromfenac group between time elapsed from instillation and drug concentration was -0.16 (p not significant). Bromfenac showed properties of good penetration and stable concentration in aqueous humor up to about 12 h after instillation.

Design of Novel Ophthalmic Formulation Containing Drug Nanoparticles and Its Usefulness as Anti-glaucoma Drugs.

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Nagai, Noriaki

2016-01-01

The ophthalmic application of drugs is the primary route of administration for the therapy of glaucoma; however, in traditional formulations, only small amounts of the administered drug penetrate the cornea to reach the desired intraocular tissue due to corneal barriers. Recently, nanoparticulate drug delivery is expected as a technology to overcome the difficulties in delivering drugs across biological barriers (improvement of bioavailability). In this study, we attempted to establish a new method for preparing solid drug nanoparticles by using a bead mill and various additives, and succeeded in preparing a high quality dispersion containing drug nanoparticles. For a more concrete example, a mean particle size of disulfiram (DSF) treated with bead mill is 183 nm. The corneal penetration and corneal residence time of DSF from the ophthalmic dispersion containing DSF nanoparticles were significantly higher than those from a 2-hydroxypropyl-β-cyclodextrin solution containing DSF (DSF solution). It is known that the administration of DSF has intraocular pressure (IOP)-reducing effects. The IOP-reducing effects of the ophthalmic dispersion containing DSF nanoparticles were significantly greater than those of the DSF solution in rabbits (the IOP was enhanced by placing the rabbits in a dark room for 5 h). In addition, the ophthalmic dispersion containing DSF nanoparticles is better tolerated by corneal epithelial cells than DSF solution. It is possible that dispersions containing DSF nanoparticles provide new possibilities for effectively treating glaucoma, and that ocular drug delivery systems using drug nanoparticles may expand their usage for therapy in the ophthalmologic field.

21 CFR 886.4230 - Ophthalmic knife test drum.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic knife test drum. 886.4230 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4230 Ophthalmic knife test drum. (a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical...

21 CFR 886.5800 - Ophthalmic bar reader.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar reader. 886.5800 Section 886.5800...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5800 Ophthalmic bar reader. (a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a...

21 CFR 886.1650 - Ophthalmic bar prism.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic bar prism. 886.1650 Section 886.1650...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1650 Ophthalmic bar prism. (a) Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing...

21 CFR 886.4750 - Ophthalmic eye shield.

Science.gov (United States)

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4750 Ophthalmic eye shield. (a) Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic eye shield. 886.4750 Section 886.4750...

Ophthalmic Disorders in Adults with Down Syndrome

Directory of Open Access Journals (Sweden)

Sharon J. Krinsky-McHale

2012-01-01

Full Text Available A myriad of ophthalmic disorders is associated with the phenotype of Down syndrome including strabismus, cataracts, and refractive errors potentially resulting in significant visual impairment. Ophthalmic sequelae have been extensively studied in children and adolescents with Down syndrome but less often in older adults. In-depth review of medical records of older adults with Down syndrome indicated that ophthalmic disorders were common. Cataracts were the most frequent ophthalmic disorder reported, followed by refractive errors, strabismus, and presbyopia. Severity of intellectual disability was unrelated to the presence of ophthalmic disorders. Also, ophthalmic disorders were associated with lower vision-dependent functional and cognitive abilities, although not to the extent that was expected. The high prevalence of ophthalmic disorders highlights the need for periodic evaluations and individualized treatment plans for adults with Down syndrome, in general, but especially when concerns are identified.

Enhancement and inhibition effects on the corneal permeability of timolol maleate: Polymers, cyclodextrins and chelating agents.

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Rodríguez, Isabel; Vázquez, José Antonio; Pastrana, Lorenzo; Khutoryanskiy, Vitaliy V

2017-08-30

This study investigates how both bioadhesive polymers (chitosan, hyaluronic acid and alginate) and permeability enhancers (ethylene glycol- bis(2-aminoethylether)- N, N, N', N'- tetraacetic acid (EGTA) and hydroxypropyl-ß-cyclodextrin) influence the permeability of the anti-glaucoma drug timolol maleate through ex vivo bovine corneas. Our results showed that only the permeability enhancers alone were able to increase drug permeability, whereas the polymers significantly reduced drug permeation, and however, they increased the pre-corneal residence of timolol. Ternary systems (polymer-enhancer-drug) showed a reduced drug permeability compared to the polymers alone. Fluorescence microscopy analysis of the epithelium surface confirmed there was no evidence of epithelial disruption caused by these formulations, suggesting that polymer-enhancer interactions reduce drug solubilization and counteract the disruptive effect of the permeability enhancers on the surface of the cornea. Further mucoadhesive tests, revealed a stable interaction of chitosan and hyaluronic acid with the epithelium, while alginate showed poor mucoadhesive properties. The differences in mucoadhesion correlated with the permeability of timolol maleate observed, i.e. formulations containing mucoadhesive polymers showed lower drug permeabilities. The results of the present study indicate polymers acting as an additional barrier towards drug permeability which is even more evident in the presence of permeability enhancers like EGTA and hydroxypropyl-ß-cyclodextrin. Then, this study highlights the need to adequately select additives intended for ocular applications since interactions between them can have opposite results to what expected in terms of drug permeability. Copyright © 2017 Elsevier B.V. All rights reserved.

A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components.

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Pfeiffer, Norbert; Traverso, Carlo E; Lorenz, Katrin; Saarela, Ville; Liinamaa, Johanna; Uusitalo, Hannu; Astakhov, Yury; Boiko, Ernest; Ropo, Auli

2014-12-01

The efficacy, safety and tolerability of the preservative-free (PF) fixed combination (FC) of tafluprost 0.0015% and timolol 0.5% (once daily) were compared to those of the individual components (PF tafluprost 0.0015% once daily and PF timolol 0.5% twice daily) in patients with open-angle glaucoma or ocular hypertension inadequately controlled on prior timolol or prostaglandin monotherapy for 6 months. A stratified, double-masked, randomized, multicenter phase III study was conducted. A total of 189 prior timolol users were randomized within the timolol stratum (TS) to receive either FC (n = 95) or timolol 0.5% (TIM; n = 94). Furthermore, a total of 375 prior prostaglandin analog (PGA) users were randomized within the prostaglandin stratum (PS) to receive either FC (n = 188) or tafluprost 0.0015% (TAF; n = 187). To be eligible for participation in the study, the patients were required to have an intraocular pressure (IOP) of ≥22 mmHg when on timolol (TIM) or of ≥20 mmHg when on PGA in either treated eye at the screening and end-of-run-in visits. In addition to these, the study included visits at baseline, 2 and 6 weeks, 3 and 6 months and at a post-study visit. IOP was measured at 8 a.m., 10 a.m., 4 p.m., and 8 p.m. In the TS, a significant reduction from baseline IOP was seen with FC and TIM throughout the study. Average diurnal IOP change from baseline at month 3 was -8.55 mmHg (32%) for FC and -7.35 mmHg (28%) for TIM. The model-based treatment difference (FC-TIM) was -0.885 mmHg [95% confidence interval (CI) -1.745 to -0.024; p = 0.044] demonstrating the superiority of FC over TIM. In the PS, a significant reduction in IOP was seen with both FC and TAF throughout the study. The average diurnal IOP change from baseline at month 3 was -8.61 mmHg (33%) for FC and -7.23 mmHg (28%) for TAF. The model-based treatment difference (FC-TAF) was -1.516 mmHg (95% CI -2.044 to -0.988; p preservative-free fixed combination of tafluprost and

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

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Schwenn Oliver

2010-09-01

Full Text Available Abstract Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP, visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population, the primary reasons for switching were inadequate IOP reduction (78.2% and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible. In all, 1317 (56.3% subjects completed the study, and 1028 (44.0% were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up.

Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review

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Dubald, Marion; Bourgeois, Sandrine; Andrieu, Véronique; Fessi, Hatem

2018-01-01

The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites. PMID:29342879

Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review

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Marion Dubald

2018-01-01

Full Text Available The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites.

21 CFR 886.1410 - Ophthalmic trial lens clip.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or...

Effects of Topical Bimatoprost 0.01% and Timolol 0.5% on Circadian IOP, Blood Pressure and Perfusion Pressure in Patients with Glaucoma or Ocular Hypertension: A Randomized, Double Masked, Placebo-Controlled Clinical Trial.

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Francesco Oddone

Full Text Available To compare the 24-hour (24h effects on intraocular pressure (IOP and cardiovascular parameters of timolol 0.5% and bimatoprost 0.01% in open angle glaucoma and ocular hypertensive subjects.In this prospective, randomized, double masked, crossover, clinical trial, after washout from previous medications enrolled subjects underwent 24h IOP, blood pressure (BP and heart rate (HR measurements and were randomized to either topical bimatoprost 0.01% at night plus placebo in the morning or to timolol 0.5% bid. After 8 weeks of treatment a second 24h assessment of IOP, BP and HR was performed and then subjects switched to the opposite treatment for additional 8 weeks when a third 24h assessment was performed. The primary endpoint was the comparison of the mean 24h IOP after each treatment. Secondary endpoints included the comparisons of IOP at each timepoint of the 24h curve and the comparison of BP, HR, ocular perfusion pressure and tolerability.Mean untreated 24h IOP was 20.3 mmHg (95%CI 19.0 to 21.6. Mean 24h IOP was significantly lower after 8 weeks of treatment with bimatoprost 0.01% than after 8 weeks of treatment with timolol 0.5% bid (15.7 vs 16.8 mmHg, p = 0.0003. Mean IOP during the day hours was significantly reduced from baseline by both drugs while mean IOP during the night hours was reduced by -2.3 mmHg (p = 0.0002 by bimatoprost 0.01% plus placebo and by -1.1 mmHg by timolol 0.5% bid (p = 0.06. Timolol 0.5% significantly reduced the mean 24h systolic BP from baseline, the diastolic BP during the day hours, the HR during the night hours, and the mean 24h systolic ocular perfusion pressure.Both Bimatoprost 0.01% and Timolol 0.5% are effective in reducing the mean 24h IOP from an untreated baseline but Bimatoprost 0.01% is more effective than timolol 0.5% throughout the 24h. Timolol 0.5% effect on IOP is reduced during the night hours and is associated with reduced BP, HR and ocular perfusion pressure.EU Clinical Trial Register and Eudra

Intraocular pressure decrease with preservative-free fixed and unfixed combination of tafluprost and timolol in pseudoexfoliative glaucoma.

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Holló, Gábor; Ropo, Auli

2015-01-01

We investigated the intraocular pressure (IOP) lowering efficacy of preservative-free fixed and non-fixed combination of tafluprost 0.0015% and timolol 0.5% in pseudoexfoliative glaucoma (XFG). A per protocol worse eye analysis was made on all XFG patients who participated in a recent 6 month, prospective, randomized, double-masked, parallel group, multicenter phase III study. The mean time-wise IOP decreased by 8.62 to 10.25 mmHg (31.8 to 36.7%) in the fixed dose combination arm (15 patients) and by 5.38 to 11.35 mmHg (21.3 to 41.2%) in the non-fixed combination arm (13 patients), respectively (p preservative-free fixed dose combination of tafluprost and timolol provides a clinically significant IOP reduction in XFG, and may offer an advantage for the XFG patients with dry eye, due to its preservative-free nature.

21 CFR 886.1405 - Ophthalmic trial lens set.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers...

Evaluation of endothelial mucin layer thickness after phacoemulsification with next generation ophthalmic irrigating solution.

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Ghate, Deepta A; Holley, Glenn; Dollinger, Harli; Bullock, Joseph P; Markwardt, Kerry; Edelhauser, Henry F

2008-10-01

To evaluate human corneal endothelial mucin layer thickness and ultrastructure after phacoemulsification and irrigation-aspiration with either next generation ophthalmic irrigating solution (NGOIS) or BSS PLUS. Paired human corneas were mounted in an artificial anterior chamber, exposed to 3 minutes of continuous ultrasound (US) at 80% power using the Alcon SERIES 20000 LEGACY surgical system (n = 9) or to 2 minutes of pulsed US at 50% power, 50% of the time at 20 pps using the Alcon INFINITI Vision System (n = 5), and irrigated with 250 mL of either NGOIS or BSS PLUS. A control group of paired corneas did not undergo phacoemulsification or irrigation-aspiration (n = 5). Corneas were divided and fixed for mucin staining or transmission electron microscopy. Mucin layer thickness was measured on the transmission electron microscopy prints. The mucin layer thickness in the continuous phaco group was 0.77 +/- 0.02 microm (mean +/- SE) with NGOIS and 0.51 +/- 0.01 microm with BSS PLUS (t test, P INFINITI Vision System (pulsed US) and the LEGACY surgical system (continuous US).

Preformulation study of methazolamide for topical ophthalmic delivery: physicochemical properties and degradation kinetics in aqueous solutions.

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Jiang, Sunmin; Wang, Fengzhen; Zhu, Shuning; Zhang, Xiumei; Guo, Zhigang; Li, Rui; Xu, Qunwei

2013-05-20

Methazolamide (MTZ) is an anti-glaucoma drug. The present paper aims to characterize the physicochemical properties and degradation kinetics of MTZ to provide a basis for topical ophthalmic delivery. With the increase in pH (pH 5.5-8.0) of aqueous solution, the solubility of the compound increased while the partition coefficient (Ko/w) which was estimated in the system n-octanol/aqueous solution decreased. The degradation of MTZ in aqueous solution followed pseudo-first-order kinetic. The degradation rate kpH is the rate in the absence of buffer catalysis. Plotting the natural logarithm of kpH versus the corresponding pH value gave a V-shaped pH-rate profile with a maximum stability at pH 5.0. The degradation rate constants as a function of the temperature obeyed the Arrhenius equation (R(2)=0.9995 at pH 7.0 and R(2)=0.9955 at pH 9.0, respectively). A decrease in ionic strength and buffer concentration displayed a stabilizing effect on MTZ. Buffer species also influenced the MTZ hydrolysis. Phosphate buffer system was more catalytic than tris and borate buffer systems. In brief, it is important to consider the physicochemical properties and the stability of MTZ during formulation. Copyright © 2013 Elsevier B.V. All rights reserved.

21 CFR 886.3100 - Ophthalmic tantalum clip.

Science.gov (United States)

2010-04-01

... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study.

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Sheppard, John D; Torkildsen, Gail L; Lonsdale, John D; D'Ambrosio, Francis A; McLaurin, Eugene B; Eiferman, Richard A; Kennedy, Kathryn S; Semba, Charles P

2014-02-01

To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry eye disease. Prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial. A total of 588 adult subjects with dry eye disease. Eligible subjects were randomized 1:1 to receive topically administered lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo run-in period. After enrollment (day 0), subjects were evaluated at days 14, 42, and 84. Key objective (fluorescein and lissamine staining scores [Ora scales]) and subjective (Ocular Surface Disease Index [OSDI], 7-item visual analog scale, and ocular discomfort score [Ora scale]) measures were assessed at all visits. The primary objective efficacy measure (sign) was mean change from baseline inferior corneal staining score (ICSS) at day 84. The co-primary subjective efficacy measure (symptom) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores (superior, central, total region) and conjunctival lissamine scores (nasal, temporal, total region) and symptom scores at day 84. The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo (P = 0.0007). Lifitegrast significantly reduced corneal fluorescein staining (superior, P = 0.0392; total cornea, P = 0.0148) and conjunctival lissamine staining (nasal, P = 0.0039; total conjunctiva, P = 0.0086) at day 84 versus placebo. Significant (P ophthalmic solution 5.0% significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Does Uniformity of Topical Corticosteroid Ophthalmic Medications: Flourometholone Acetate 0.1 Suspension and Loteprednol Etabonate 0.5 gel

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2017-01-03

following ocular surgery.1 They are available in different forms including emulsions , ointments, solutions, gels, and suspensions. The choice of...study done by Stringer and Bryant compared dose uniformity of difluprednate ophthalmic emulsion (Durezol®) with prednisolone acetate (brand name...topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979;87(2): 210- 214. 5 Flarex® [ package insert]. Fort Worth, TX: Alcon Laboratories Inc

Avaliação eletrocardiográfica de cães clinicamente hígidos sob tratamento com solução oftálmica de maleato de timolol 0,5%: estudo preliminar

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Riane Moreira Santos

2015-06-01

Full Text Available O maleato de timolol 0,5% é um fármaco recomendado para tratamento de glaucoma em cães. Após instilação, e absorvido para a circulação sistêmica e por ser um antagonista beta-adrenérgico pode promover efeitos colaterais sistêmicos importantes sobre a condução elétrica cardíaca. No presente estudo, foi avaliada a alteração causada pelo timolol 0,5% oftálmico no eletrocardiograma. Foram selecionados seis cães hígidos para participar de dois tratamentos oftálmicos diferentes: no primeiro foi instilado placebo (hipromelose 0,5% e no segundo utilizou-se timolol 0,5%. O colírio foi instilado a cada 12 horas por 14 dias. Os parâmetros eletrocardiográficos foram mensurados nos tempos: zero, 10, 60, 120, 240, 360 e 720 minutos após instilação da solução ocular nos dias primeiro, sétimo e décimo quarto de cada tratamento. As alterações eletrocardiográficas foram mais evidentes entre 120 e 240 minutos pós-instilação de timolol 0,5% quando comparado com o tratamento placebo. O ritmo foi irregular, com momentos de arritmia sinusal e bradicardia sinusal. Os intervalos RR e PR prolongaram significativamente (p 0,05. Apesar das alterações encontradas, não foram observadas manifestações clínicas relacionadas ao timolol nos animais estudados. Deve-se considerar, porém, que os animais em questão eram hígidos e, portanto, as alterações decorrentes do uso do timolol em animais com cardiopatias preexistentes poderiam promover sinais clínicos, sendo recomendada a avaliação cardíaca de pacientes previamente à prescrição do timolol oftálmico.

Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension

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Lorenz K

2011-12-01

Full Text Available Katrin Lorenz1, Klaus Rosbach2, Andreas Matt3, Norbert Pfeiffer11University Medical Center, Johannes Gutenberg-Universität Mainz, Mainz, Germany; 2Private practice, Mainz, Germany; 3Private practice, Köln-Hohenhaus, GermanyBackground: This study was conducted to evaluate the safety and efficacy of adding a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin analog (PGA monotherapy in patients with primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension who require additional intraocular pressure (IOP reduction.Methods: This was a prospective, multicenter (n = 5, open-label, single-arm, Phase IV clinical trial in which patients currently being treated with a PGA but requiring additional IOP reduction were administered brinzolamide 1%/timolol 0.5% twice daily as adjunctive therapy to their current PGA monotherapy regimen. The primary objective was to examine the IOP-lowering efficacy of brinzolamide-timolol when used as adjunctive therapy.Results: Forty-seven patients enrolled in and completed the study. After 12 weeks of adjunctive brinzolamide-timolol therapy, the mean IOP of the total patient population decreased from 22.1 mmHg at baseline to 16.7 mmHg. The mean IOP reduction of 5.4 mmHg (24.4% was both clinically and statistically significant (P < 0.001. This significant decrease in mean IOP at week 12 was maintained across all PGA groups (P < 0.05. No significant differences were observed in symptom frequency between baseline and week 12 for any of the six solicited symptoms. A total of 17 adverse events from six patients was reported, of which ten were drug-related. Most (n = 7 of the drug-related adverse events were mild or moderate in intensity. None of the adverse events required any treatment or resulted in treatment interruption or discontinuation. Of the 90 eligible eyes, 85.6% had a decrease in IOP of at least 3 mmHg from baseline and 98% of patients had a decrease in IOP of ≥1 mm

Azithromycin 1.5% ophthalmic solution: efficacy and treatment modalities in chronic blepharitis

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Ali Fadlallah

2012-06-01

Full Text Available PURPOSE: To assess the efficacy of topical 1.5% azithromycin in the treatment of moderate to severe chronic blepharitis and to compare the efficacy of two different treatment modalities. METHODS: A randomized clinical trial included 67 patients with chronic anterior and/or posterior blepharitis, followed-up for 3 months. Signs and symptoms were graded according to severity. Patients were randomized into two groups: 33 patients in group I and 34 patients in group II. Group I patients were treated with topical 1.5% azithromycin twice a day for three days, and Group II patients were treated with topical 1.5% azithromycin twice a day for three days then at bedtime for the rest of the month. All patients were instructed to apply warm compresses and an eye-friendly soap twice daily. RESULTS: Patients in both groups tolerated the treatment with minimal irritation. A significant improvement in signs and symptoms was noted at the one week follow-up visit. Group II showed a more pronounced and longer-lasting improvement that persisted after three months of follow-up. CONCLUSION: Topical 1.5% azithromycin ophthalmic solution is an effective treatment option for chronic blepharitis. In moderate to severe blepharitis, a one month treatment is safe and shows better improvement than the three-day protocol with no significant relapse until three months of follow-up.

Shortcomings of the industrial quality assurance of 106Ru ophthalmic plaques

International Nuclear Information System (INIS)

Kaulich, T.W.; Nuesslin, F.; Fluehs, D.; Haug, T.; Bamberg, M.

2001-01-01

Background: Beta emitting 106 Ru applicators manufactured by Bebig GmbH (Berlin, Germany) are widely used to treat intraocular tumors. The applicators are fixed to the bulbus and removed after several days. The following therapy relevant defects have been detected by an internal clinical acceptance test: risk of leakage and inconsistent dose-rate specifications by the manufacturer. In the meantime, components of the internal clinical acceptance test have been adopted successfully by the manufacturer of the 106 Ru ophthalmic plaques. Material and Method: 106 Ru ophthalmic plaques were tested with the following internal clinical acceptance tests: visual inspection, surface contamination, leakage, and dose-rate verification. The surface contamination test consists of a wet wipe test at moderate pressure. For the leakage test of the 106 Ru ophthalmic plaques a clinically relevant scenario was developed in which the contact of the applicator with human tissue is simulated. In the course of it the applicator is inserted into Ringer's solution for several days. The certified energy dose-rate statements of the manufacturer are examined with a 1 mm 3 plastic scintillator for consistency. (orig.) [de

Safety comparison of additives in antiglaucoma prostaglandin (PG analog ophthalmic formulations

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Fukuda M

2013-03-01

Full Text Available Masamichi Fukuda, Shinsuke Shibata, Naoko Shibata, Kenta Hagihara, Hiromoto Yaguchi, Hiromi Osada, Nobuo Takahashi, Eri Kubo, Hiroshi SasakiDepartment of Ophthalmology, Kanazawa Medical University, Uchinada, JapanPurpose: To investigate the safety of five types of antiglaucoma prostaglandin analog ophthalmic formulations, and to clarify their differences in accordance with contained additives (preservatives and surface-active agents.Methods: The following five types of ophthalmic solutions and three types of additives were investigated: latanoprost (Xalatan®; latanoprost, tafluprost (Tapros®; tafluprost, bimatoprost (Lumigan®; bimatoprost, travoprost (Travatan®; travoprost, travoprost (Travatan Z®; travoprost-Z, benzalkonium chloride (BAK, polyoxyethylene hardening castor oil 40 (HCO-40, and polysorbate 80 (P-80. These experimental solutions were exposed to the cultured cells of a rabbit-derived corneal cell line for a certain time, and the exposure time causing 50% cell damage (CD50, indicated by the ratio of viable cells to total cells was calculated (in vitro. In addition, corneal resistance (CR was measured and CR ratio (post-treatment CR/pretreatment CR × 100 was calculated (in vivo.Results: CD50 of each ophthalmic solution was the longest with tafluprost, followed by travoprost-Z, bimatoprost, travoprost, and latanoprost. CD50 of 0.005%, 0.01%, and 0.02% BAK was 14.5 minutes, 8.1 minutes, and 4.0 minutes, respectively. The number of viable cells decreased to 60%, 8 minutes after exposure with HCO-40, and 30 minutes after being exposed to P-80. The CR ratio was 81.0% with travoprost and 82.0% with latanoprost, indicating a significant posttreatment reduction of CR (P < 0.05. The CR ratio did not decrease after treatment with tafluprost, travoprost-Z, or bimatoprost. The CR ratio of 0.005%, 0.01%, and 0.02% BAK was 105.0%, 90.5%, and 68.7%, respectively, and that of HCO-40 and P-80 was 108.7% and 114.2%, respectively.Conclusion: BAK

Efficacy and tolerability of preservative-free eye drops containing a fixed combination of dorzolamide and timolol in glaucoma patients.

Science.gov (United States)

Renieri, Giulia; Führer, Katrin; Scheithe, Karl; Lorenz, Katrin; Pfeiffer, Norbert; Thieme, Hagen

2010-12-01

To evaluate the efficacy and tolerability of preservative-free eye drops (dorzolamide/timolol) in routine management of preservative-sensitive glaucoma patients. Data from 2,298 glaucoma patients requiring intraocular pressure (IOP) reduction and suffering from intolerance to benzalkonium chloride or active agents of previously used eye drops were valid for baseline and safety analysis in this prospective, open, noncomparative, multicenter, noninterventional study. Patients were treated with preservative-free dorzolamide/timolol eye drops for 12 weeks. Main efficacy endpoint was IOP reduction after 12 weeks of treatment. Two thousand forty-nine patients were considered for efficacy analysis. Tolerability was assessed by evaluating adverse drug reactions. Mean baseline IOP was 20.8 mmHg. Baseline IOP was reduced to 16.7 mmHg after 12 weeks of treatment corresponding to a mean absolute (percent) change of -4.1 mmHg (-17.3%). The proportion of patients with IOP ≤21 mmHg increased from 59.9% at baseline to 94.6% after 12 weeks. The most frequently reported ocular adverse drug reactions were burning eyes (2.4%) and hyperemia (0.9%). Local tolerability improved in 79.3% of patients compared to their previous glaucoma therapy. This observational study confirms the IOP lowering effect of preservative-free eye drops containing the fixed combination of dorzolamide/timolol in a large patient's population. The drug was well tolerated and improved the local tolerability in the vast majority of patients.

Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.

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Suzuki, Katsuyoshi; Otsuka, Naomi; Hizaki, Hiroko; Hashimoto, Masayo; Kuwayama, Yasuaki

2018-06-05

This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM). This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire. In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group. TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores. UMIN Clinical Trials Registry Identifier

Assessment of ocular hypotensive effect and safety 12 months after changing from an unfixed combination to a latanoprost 0.005% + timolol maleate 0.5% fixed combination.

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Inoue, Kenji; Okayama, Ryoko; Higa, Risako; Wakakura, Masato; Tomita, Goji

2012-01-01

Latanoprost 0.005% + timolol maleate 0.5% combined eyedrops were recently made available in Japan. We prospectively investigated the intraocular pressure (IOP)-lowering effect, visual preservation effect, and adverse reactions of a one-year administration of this fixed combination. The subjects included 162 eyes from 162 patients diagnosed with either primary open-angle glaucoma or ocular hypertension and using an unfixed combination of latanoprost 0.005% and timolol maleate 0.5%. The unfixed combination was discontinued and replaced with the latanoprost 0.005% + timolol maleate 0.5% fixed combination with no washout period. IOP was measured before (baseline) and 3, 6, 9, and 12 months after the change. The mean deviation value of Humphrey field analysis was compared. Adverse reactions were examined at every follow-up. No significant differences were found between mean IOP values obtained at baseline (mean ± standard deviation, 15.2 ± 3.3 mmHg) 3 months (15.1 ± 3.2 mmHg), 6 months (15.3 ± 3.1 mmHg), 9 months (15.3 ± 3.1 mmHg), and 12 months (15.1 ± 3.2 mmHg) after the change from the unfixed to the fixed combination of eyedrops (P = 0.212). In addition, no significant differences were observed between mean deviation values obtained at baseline (-9.11 ± 6.94 dB) and 12 months (-10.08 ± 7.24 dB) after the change (P = 0.114). Thirty-one patients discontinued the fixed combination within 12 months of replacement, due to an insufficient IOP decrease (20 patients, 12.3%) and adverse reactions (11 patients, 6.8%). Following replacement of two eyedrop medications (latanoprost 0.005% and timolol maleate 0.5%) by one fixed combination (latanoprost 0.005% + timolol maleate 0.5%), IOP and visual field were preserved. However, 20% of the patients discontinued the new treatment because of an insufficient IOP decrease and complaints of adverse reactions.

Immediate Effect of 3% Diquafosol Ophthalmic Solution on Tear MUC5AC Concentration and Corneal Wetting Ability in Normal and Experimental Keratoconjunctivitis Sicca Rat Models.

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Choi, Kwang-Eon; Song, Jong-Suk; Kang, Boram; Eom, Youngsub; Kim, Hyo-Myung

2017-05-01

To evaluate the immediate effect of 3% diquafosol ophthalmic solution on tear MUC5AC concentration, periodic acid-Schiff (PAS)-positive goblet cells, and tear film stability in normal and keratoconjunctivitis sicca (KCS) rat models. Rats were divided into normal and KCS groups. 3% of diquafosol solution was instilled into the right eye and normal saline into the left eye in both groups. To determine the peak time of tear MUC5AC concentration, tears were collected after 3% diquafosol instillation every 5 min up to 20 min. The tear film stability and the numbers of PAS-positive goblet cells were compared in both models. After diquafosol instillation, tear MUC5AC concentration increased steadily for 15 min, at which point the MUC5AC concentration reached its peak. In both normal and KCS groups, the MUC5AC concentration at 15 min was higher after instillation of 3% diquafosol solution (17.77 ± 2.09 ng/ml in the normal group, 9.65 ± 3.51 ng/ml in the KCS group) than that after saline instillation (13.74 ± 2.87 ng/ml in the normal group, 8.19 ± 3.99 ng/ml in the KCS group) (p = 0.018 for both). The corneal wetting ability was significantly longer after instillation of 3% diquafosol solution compared with that after instillation of normal saline in the normal group (p = 0.018). The percentage of PAS-positive goblet cells after the instillation of 3% diquafosol solution was significantly lower than that after instillation of normal saline in both models (p = 0.018 for both). Diquafosol ophthalmic solution was effective in stimulating mucin secretion in both normal and KCS rat models, and the peak time of tear MUC5AC concentration was 15 min after diquafosol instillation. The increased tear MUC5AC concentration was accompanied by improved tear film stability and a decreased percentage of PAS-positive goblet cells.

21 CFR 886.1415 - Ophthalmic trial lens frame.

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2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision...

[Clinical pilot study to evaluate the efficacy of a preservative-free hypertonic ophthalmic solution for patients with symptomatic corneal edema].

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Rouland, J-F

2015-11-01

This exploratory clinical trial aims to assess the effect on visual acuity and central corneal thickness of an unpreserved hypertonic ophthalmic solution containing sodium chloride (5%) and sodium hyaluronate, in patients with chronic corneal edema caused by endothelial disease reducing their visual acuity. Twenty patients were enrolled and treated with the hypertonic solution (1 to 2 drops per eye, 4 times a day over 28 days). Progression of visual acuity (ETDRS score) and corneal thickness (ultrasonic pachymetry) was measured from baseline (without treatment) through the treatment period (Day 7 and Day 28). The analyses were performed on 18 patients (Full Analysis Set [FAS] population). The causes of corneal edema were Fuchs endothelial dystrophy in 10 cases and post-cataract surgery endothelial decompensation in 8 patients. The mean visual acuity values for the FAS population compared between baseline (Day-7) and one week of treatment (Day+7) show a significant 5-point VA improvement (Psolution containing sodium chloride and sodium hyaluronate significantly improved ETDRS visual acuity after one week of use. In this clinical trial, the solution also showed excellent tolerability results. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Efficacy of contact lens disinfecting solutions against Staphylococcus aureus and Pseudomonas aeruginosa.

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Manuj, Kapur; Gunderson, Charlise; Troupe, John; Huber, Mary E

2006-07-01

To evaluate the disinfection properties of multipurpose contact lens disinfection solutions, based on the International Organization for Standardization (ISO) 14729 guidelines. ReNu with MoistureLoc Multi-Purpose Solution, OPTI-FREE Express with Aldox Multi-Purpose Solution, Betadine 5% sterile ophthalmic preparation solution (povidone iodine), and 0.9% normal saline solution were inoculated with strains of Staphylococcus aureus and Pseudomonas aeruginosa. Surviving bacteria were quantified at specified times. ReNu with MoistureLoc, OPTI-FREE Express, and 5% ophthalmic povidone iodine were effective in achieving a 5-log reduction in bacterial count. Additionally, all three products maintained their effectivity at 72 hours. However, ReNu with MoistureLoc and povidone iodine resulted in the greatest reduction in bacterial colonization. ReNu with MoistureLoc, OPTI-FREE Express, and 5% ophthalmic povidone iodine meet the ISO 14729 guidelines for standalone contact lens solutions. However, ReNu with MoistureLoc and 5% ophthalmic povidone iodine are most efficient in reducing and maintaining low bacterial count for a period of 72 hours.

Sildenafil dilates ophthalmic artery in type 2 diabetic patients

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Akeel AMH Zwain

2013-08-01

Full Text Available Background: Conflicting reports exist on the effect of sildenafil on ophthalmic artery blood flow; many visual disturbances due to vascular insult were reported with the use of sildenafil in diabetic patients like nonarteritic ischemic optic neuropathy. Objectives: The present work aimed to investigate whether sildenafil modulates ophthalmic artery vasoreactivity in patients with type 2 diabetes mellitus. Literature reports on this aspect are lacking. Methods: A total of 35 male subjects were enrolled in this study, 18 with type 2 diabetes mellitus matched with 17 normal individuals. Ophthalmic artery was insonated through a transorbital window using colored Doppler equipment with transcranial Doppler facility. Ophthalmic artery reactivity was assessed using breath holding/hyperventilation test, before and after giving 50 mg oral sildenafil. Results: It was found that in both normal subjects and diabetic patients, sildenafil increased baseline control of mean flow velocity of ophthalmic artery significantly (p 0.05 after sildenafil, in normal and diabetic groups. There was a significant increase of resistive index of ophthalmic artery flow in diabetic patients compared with that of normal subject (p < 0.05. Sildenafil decreased resistive index of ophthalmic artery flow significantly only in diabetic patients (p < 0.05. Conclusion: Sildenafil increased MFVopa, but had no significant effect on vasoreactivity of ophthalmic artery; sildenafil decreased resistive index only in type 2 diabetic patients.

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5% compared with branded and generic prednisolone acetate ophthalmic suspension (1%

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Marlowe ZT

2013-12-01

Full Text Available Zora T Marlowe, Stephen R DavioPharmaceutical Product Development, Global Pharmaceutical Research and Development, Bausch and Lomb, Inc, Rochester, NY, USAIntroduction: Loteprednol etabonate (LE ophthalmic gel 0.5% (Lotemax® is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte® and a generic prednisolone acetate suspension 1% were used as comparators.Methods: Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing – consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC method and reported as a percentage of the declared (labeled concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity.Results: Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD] percent declared concentration of 102% (1.92% over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively, with mean concentrations for both falling significantly

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%).

Science.gov (United States)

Marlowe, Zora T; Davio, Stephen R

2014-01-01

Loteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators. Drug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing - consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC) method and reported as a percentage of the declared (labeled) concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity. Mean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD]) percent declared concentration of 102% (1.92%) over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively), with mean concentrations for both falling significantly below the declared concentration for drops expressed at the beginning of the 2-week dosing regimen and significantly above the declared concentration for drops expressed near the end of the dosing

Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America.

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Susanna, Remo; Sussana, Remo; Sheu, Wang-Pui

2004-05-01

The newer ocular hypotensive agents available to treat glaucoma and ocular hypertension (OHT) include latanoprost, a prostaglandin F(2alpha) analogue, and the fixed combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker. The aim of this study was to compare the efficacy and tolerability of latanoprost with that of the fixed combination of dorzolamide and timolol over 8 weeks. This interventional, 8-week, randomized, open-label, parallel-group study was conducted at 18 centers in 6 Latin American countries. Patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT were randomized to receive latanoprost, 1 drop in the affected eye QD (evening), or fixed-combination dorzolamide/timolol, 1 drop in the affected eye BID (morning and evening). Medications were self-administered, 1 drop per affected eye. At baseline and week 8, intraocular pressure (IOP) was measured 3 times each at 8:30 am, 10:00 am, 2:00 pm, and 5:00 pm and after the water-drinking test, which estimates the IOP peak of diurnal tension curve, performed following the 5:00 pm IOP assessment. The primary efficacy outcome was change in diurnal IOP (the mean of IOP measurements) from baseline to week 8. Adverse effect (AE) data were recorded at each visit. A total of 229 patients were randomized (latanoprost, n = 112; dorzolamide/timolol, n = 117). Mean baseline diurnal IOP values were similar between the 2 groups. Mean (SD) diurnal IOP reductions at week 8 before the water-drinking test were 6.9 (3.0) mm Hg for the latanoprost group and 6.4 (3.2) mm Hg for the dorzolamide/timolol group. Mean IOP values were similar at all time points except at 5:00 pm, when levels were significantly lower in latanoprost-treated patients (P = 0.025). After the water-drinking test, the increase in IOP values was similar between groups at baseline but lower in latanoprost-treated patients at week 8 (adjusted difference, 1.08 mm Hg

Effects of 3% diquafosol sodium ophthalmic solution on higher-order aberrations in patients diagnosed with dry eye after cataract surgery

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Inoue Y

2016-12-01

Full Text Available Yasushi Inoue, Shintarou Ochi Inoue Eye Clinic, Tamano, Okayama, Japan Purpose: To evaluate the effects of diquafosol sodium ophthalmic solution 3% (DQS and artificial tears (AT on higher-order aberrations (HOAs in patients with dry eye after cataract surgery. Design: This was a post hoc analysis of a previously conducted randomized clinical study. Methods: Fifty-nine eyes from 42 patients (17 males and 25 females, aged 72.6±8.0 years with verified or suspected dry eye at 4 weeks after cataract surgery were evaluated. The dry eye patients were randomly assigned to receive DQS or AT for 4 weeks. Tear breakup time (BUT, corneal and conjunctival fluorescein staining scores, and HOAs were analyzed before and after instillation. HOAs were measured consecutively for 10 seconds with a wavefront analyzer. Average HOAs, HOA fluctuations (fluctuation index [FI] and changes in HOAs (stability index [SI] were compared within and between the two groups. Results: After 4 weeks of instillation, BUT significantly increased (P=0.001 compared with preinstillation values in the DQS group, but not in the AT group. This increase in BUT in the DQS group was significantly greater than in the AT group (P=0.014. Corneal and conjunctival fluorescein staining scores after instillation significantly improved compared with preinstillation values in the DQS group (P=0.018. In HOAs, the cornea aberration changed from an upward curve (a sawtooth pattern to an almost constant value (a stable pattern in the DQS group, but not in the AT group. In FI and SI, there were no significant changes in either group; however, FI and SI were significantly lower in the DQS group than in the AT group (both, P=0.004. Conclusion: The dry eye patients after cataract surgery had a visual dysfunction in HOAs. DQS is effective to treat dry eye disease after cataract surgery with improvement of visual function. Keywords: cataract surgery, dry eye, tear film breakup time, higher-order aberrations

Alternative methods of ophthalmic treatment in Russia.

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Vader, L

1994-04-01

Russian ophthalmic nurses and physicians are using alternative methods of treatment to supplement traditional eye care. As acupuncture and iridology become more popular in the United States, ophthalmic nurses need to be more knowledgeable about these treatments and the implications for patients.

Mucoadhesive Cyclodextrin-Modified Thiolated Poly(aspartic acid as a Potential Ophthalmic Drug Delivery System

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Mária Budai-Szűcs

2018-02-01

Full Text Available Thiolated poly(aspartic acid is known as a good mucoadhesive polymer in aqueous ophthalmic formulations. In this paper, cyclodextrin-modified thiolated poly(aspartic acid was synthesized for the incorporation of prednisolone, a lipophilic ophthalmic drug, in an aqueous in situ gellable mucoadhesive solution. This polymer combines the advantages of cyclodextrins and thiolated polymers. The formation of the cyclodextrin-drug complex in the gels was analyzed by X-ray powder diffraction. The ocular applicability of the polymer was characterized by means of physicochemical, rheological and drug diffusion tests. It was established that the chemical bonding of the cyclodextrin molecule did not affect the complexation of prednisolone, while the polymer solution preserved its in situ gellable and good mucoadhesive characteristics. The chemical immobilization of cyclodextrin modified the diffusion profile of prednisolone and prolonged drug release was observed. The combination of free and immobilized cyclodextrins provided the best release profile because the free complex can diffuse rapidly, while the bonded complex ensures a prolonged action.

Diquafosol sodium ophthalmic solution for the treatment of dry eye: clinical evaluation and biochemical analysis of tear composition.

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Shigeyasu, Chika; Yamada, Masakazu; Akune, Yoko; Tsubota, Kazuo

2015-11-01

To evaluate the clinical efficacy of 3% diquafosol sodium ophthalmic solution for dry eye, and to analyze the concentration of tear proteins and mucin-like substances after the treatment. Fifty eyes of 25 patients with dry eye syndrome were prospectively enrolled. The patients were treated with diquafosol solution at a dose of 1 drop in each eye 6 times daily for 4 weeks. The parameters of clinical efficacy were tear osmolarity, tear breakup time (BUT), fluorescein staining scores for the cornea and conjunctiva, Schirmer test values, and subjective symptoms evaluated using the ocular surface disease index (OSDI). Tears collected with Schirmer test strips were analyzed by high-performance liquid chromatography, and the concentrations of the total protein and the 4 major tear proteins, namely, secretory IgA, lactoferrin, lipocalin-1, lysozyme, and N-acetyl-neuraminic acid (Neu5Ac), were measured. Neu5Ac is a major sialic acid, a marker of secretory mucins. The BUT, keratoconjunctival staining scores, and Schirmer test values were improved with statistical significance after the treatment with diquafosol solution, while changes in the other parameters, including tear osmolarity, corneal staining scores, and OSDI scores were not significant. The Neu5Ac concentration was significantly increased, which was not accompanied by changes in tear proteins. Topical application of diquafosol significantly improved the clinical parameters of the BUT, keratoconjunctival staining scores, and Schirmer test values and was accompanied by increased sialic acid content in the tears of patients with dry eye.

Preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma and ocular hypertension: results of an open-label observational study

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Pillunat LE

2017-06-01

Full Text Available Lutz E Pillunat,1 Carl Erb,2 Auli Ropo,3 Friedemann Kimmich,4 Norbert Pfeiffer5 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Augenklinik am Wittenbergplatz, Berlin, Germany; 3Santen Europe, Helsinki, Finland; 4eyecons, Pfinztal, 5Department of Ophthalmology, Mainz University Medical Center, Mainz, Germany Background: Efficacy, tolerability and safety of the novel preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% (Taptiqom® were investigated in an observational study in Germany.Objective: To assess efficacy, tolerability and safety of the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% in a real-life setting.Methods: Intraocular pressure (IOP was recorded for each eye at baseline (any previous therapy or untreated and 4–16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded.Results: Among 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naïve patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naïve patients: −8.9 mmHg, alpha-2-agonists: −6.4 mmHg, beta-blockers: −5.7 mmHg, carbonic

Stability-Indicating HPLC Method for Simultaneous Determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in Ophthalmic Solution.

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AlAani, Hashem; Alnukkary, Yasmin

2016-03-01

A simple stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in ophthalmic solution in the presence of 2-amino-1-(4-nitrophenyl)propane-1,3-diol, a degradation product of Chloramphenicol, and Dexamethasone, a degradation product of Dexamethasone Sodium Phosphate. Effective chromatographic separation was achieved using C18 column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile - phosphate buffer (pH 4.0; 0.05 M) (30:70, v/v) at a flow rate of 1 mL/minute. The column temperature was maintained at 40°C and the detection wavelength was 230 nm. The proposed HPLC procedure was statistically validated according to the ICH guideline, and was proved to be stability-indicating by resolution of the APIs from their forced degradation products. The developed method is suitable for the routine analysis as well as stability studies.

Effects of timolol maleate, levobunolol and apraclonidine on intraocular pressure, pupil size, blood pressure and heart rate in beagles

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I.R.M. Padua

2016-06-01

Full Text Available ABSTRACT The aim of this study was to evaluate changes in intraocular pressure (IOP, pupil size (PS, blood pressure (BP, heart rate (HR, and ECG variables (Pms wave PmV, PR interval, QRS complex, RMV wave and QT intervals over time during the instillation of 0.5% timolol, 0.5% levobunolol and 0.5% apraclonidine in clinically normal dogs. Ten adult beagles were used. Baseline values were measured at 8a.m., 2p.m. and 8p.m., for three consecutive days. A waiting period of 10 days between the administrations of each drug was established. For 15 consecutive days, the drug being tested was instilled in one eye of each dog twice a day (7a.m. and 7p.m.. The parameters were evaluated at the aforementioned times on days 3, 6, 9, 12 and 15. Data were statistically compared using the Bonferroni test and one-way repeated measures analysis of variance (P<0.05. The Pearson test was used to evaluate any correlation between QT interval, HR and BP. The tested drugs did not find a decrease in IOP. A significant decreased in PS was observed in almost all dogs following levobunolol administration, relative to the control eye. A significant decrease in HR was observed on day 3 following levobunolol treatment, while apraclonidine induced an increase on day 15. Blood pressure was reduced in all measurement time points following apraclonidine treatment. A negative correlation between QT interval and HR was only observed in dogs treated with timolol. In conclusion, levobunolol was the only drug that induced significant alterations in PS. Apraclonidine was the only drug that induced systemic hypotension. Timolol was the only drug to that induced a negative correlation between QT and HR.

A new kind of monitor for ophthalmic operation

International Nuclear Information System (INIS)

Li, G; Wang, L L; Wang, Y; Lin, L; Jiang, W; Lu, Stephen C-Y; Besio, Walter G

2005-01-01

The integrity of the vision channel is often checked using VEP in order to avoiding damaging important tissue during an ophthalmic operation. But the measurement of before operations has strong side effects, it may damage the eyeball. We will introduce a new kind for monitoring ophthalmic operations in this paper. It uses visual electrical evoked potential to check the integrity of the vision access and it can monitor ophthalmic operations and avoid damaging any tissue, so it ensures the safety of the operation

A new kind of monitor for ophthalmic operation

Energy Technology Data Exchange (ETDEWEB)

Li, G [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Wang, L L [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Wang, Y [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Lin, L [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Jiang, W [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Lu, Stephen C-Y [College of Precision Instrument and Opto-Electronics Engineering, Tianjin University, Tianjin, 300072 (China); Besio, Walter G [Biomedical Engineering Program, and Center for Biomedical Engineering and Rehabilitation Science Louisiana Tech. University, LA (United States)

2005-01-01

The integrity of the vision channel is often checked using VEP in order to avoiding damaging important tissue during an ophthalmic operation. But the measurement of before operations has strong side effects, it may damage the eyeball. We will introduce a new kind for monitoring ophthalmic operations in this paper. It uses visual electrical evoked potential to check the integrity of the vision access and it can monitor ophthalmic operations and avoid damaging any tissue, so it ensures the safety of the operation.

Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%

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Jack V Greiner

2011-01-01

Full Text Available Jack V Greiner1,2, Kimberly Edwards-Swanson3, Avner Ingerman41Schepens Eye Research Institute, Boston, MA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA; 3Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ; 4Ora Inc, Andover, MA, USAPurpose: To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions in treating the signs and symptoms of allergic conjunctivitis when compared with olopatadine hydrochloride 0.1% and placebo using the conjunctival allergen challenge (CAC model.Methods: One hundred and seventy subjects were randomized and 164 subjects completed all visits. CAC was performed to determine and confirm subjects’ eligibility at visits 1 and 2, respectively. The CAC was repeated at visit 3 (day 0 ± 3, 16 hours after study medication instillation, and at visit 4 (day 14 ± 3, 15 minutes after instillation. Ocular itching and conjunctival redness were evaluated after an allergen challenge, along with several secondary endpoints.Results: Alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared with placebo for ocular itching and conjunctival redness at visits 3 and 4. Most adverse events were self-limiting and mild in severity. No serious treatment-related adverse events occurred.Conclusion: Treatment with alcaftadine 0.25% ophthalmic solution resulted in mean differences of >1 unit (ocular itching and approximately >1 unit (conjunctival redness, which was significant (P < 0.001 compared with placebo treatment. All doses of alcaftadine were safe and well tolerated in the population studied.Keywords: alcaftadine, allergic conjunctivitis, conjunctival allergen challenge

Electrically atomised formulations of timolol maleate for direct and on-demand ocular lens coatings.

Science.gov (United States)

Mehta, Prina; Al-Kinani, Ali A; Haj-Ahmad, Rita; Arshad, Muhammad Sohail; Chang, Ming-Wei; Alany, Raid G; Ahmad, Zeeshan

2017-10-01

Advances in nanotechnology have enabled solutions for challenging drug delivery targets. While the eye presents numerous emerging opportunities for delivery, analysis and sensing; issues persist for conventional applications. This includes liquid phase formulation localisation on the ocular surface once administered as formulated eye-drops; with the vast majority of dosage (>90%) escaping from the administered site due to tear production and various drainage mechanisms. The work presented here demonstrates a single needle electrohydrodynamic (EHD) engineering process to nano-coat (as an on demand and controllable fiber depositing method) the surface of multiple contact lenses rendering formulations to be stationary on the lens and at the bio-interface. The coating process was operational based on ejected droplet charge and glaucoma drug timolol maleate (TM) was used to demonstrate surface coating optimisation, bio-surface permeation properties (flux, using a bovine model) and various kinetic models thereafter. Polymers PVP, PNIPAM and PVP:PNIPAM (50:50%w/w) were used to encapsulate the active. Nano-fibrous and particulate samples were characterised using SEM, FTIR, DSC and TGA to confirm structural and thermal stability of surface coated formulations. More than 52% of nano-structured coatings (for all formulations) were drainage. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

determinants of general anaesthesia for ophthalmic surgery

African Journals Online (AJOL)

DR. CHARLES IMARENGIAYE

1999-08-01

Objectives: To study the pattern of anaesthesia for ophthalmic procedures in order to improve the scheduling of cases in the ophthalmic operating room. Methods: The surgical register of the operating room from. August 01, 1999 to July 31, 2004 was examined, to document the types of procedure, timing of surgery (elective ...

Ophthalmic gels: Past, present and future.

Science.gov (United States)

Al-Kinani, Ali A; Zidan, Ghada; Elsaid, Naba; Seyfoddin, Ali; Alani, Adam W G; Alany, Raid G

2018-02-15

Aqueous gels formulated using hydrophilic polymers (hydrogels) along with those based on stimuli responsive polymers (in situ gelling or gel forming systems) continue to attract increasing interest for various eye health-related applications. They allow the incorporation of a variety of ophthalmic pharmaceuticals to achieve therapeutic levels of drugs and bioactives at target ocular sites. The integration of sophisticated drug delivery technologies such as nanotechnology-based ones with intelligent and environment responsive systems can extend current treatment duration to provide more clinically relevant time courses (weeks and months instead of hours and days) which will inevitably reduce dose frequency, increase patient compliance and improve clinical outcomes. Novel applications and design of contact lenses and intracanalicular delivery devices along with the move towards integrating gels into various drug delivery devices like intraocular pumps, injections and implants has the potential to reduce comorbidities caused by glaucoma, corneal keratopathy, cataract, diabetic retinopathies and age-related macular degeneration. This review describes ophthalmic gelling systems with emphasis on mechanism of gel formation and application in ophthalmology. It provides a critical appraisal of the techniques and methods used in the characterization of ophthalmic preformed gels and in situ gelling systems along with a thorough insight into the safety and biocompatibility of these systems. Newly developed ophthalmic gels, hydrogels, preformed gels and in situ gelling systems including the latest in the area of stimuli responsive gels, molecularly imprinted gels, nanogels, 3D printed hydrogels; 3D printed devices comprising ophthalmic gels are covered. Finally, new applications of gels in the production of artificial corneas, corneal wound healing and hydrogel contact lenses are described. Copyright © 2017 Elsevier B.V. All rights reserved.

Ultraviolet A: Visible spectral absorbance of the human cornea after transepithelial soaking with dextran-enriched and dextran-free riboflavin 0.1% ophthalmic solutions.

Science.gov (United States)

Lombardo, Marco; Micali, Norberto; Villari, Valentina; Serrao, Sebastiano; Pucci, Giuseppe; Barberi, Riccardo; Lombardo, Giuseppe

2015-10-01

To evaluate the stromal concentration of 2 commercially available transepithelial riboflavin 0.1% solutions in human donor corneas with the use of spectrophotometry. University of Calabria, Rende, Italy. Experimental study. The absorbance spectra of 12 corneal tissues were measured in the 330 to 700 nm wavelength range using a purpose-designed spectrophotometry setup before and after transepithelial corneal soaking with a 15% dextran-enriched riboflavin 0.1% solution (n = 6) or a hypotonic dextran-free riboflavin 0.1% solution (n = 6). Both ophthalmic solutions contained ethylenediaminetetraacetic acid and trometamol as enhancers. In addition, 4 deepithelialized corneal tissues underwent stromal soaking with a 20% dextran-enriched riboflavin 0.1% solution and were used as controls. All the riboflavin solutions were applied topically for 30 minutes. The stromal concentration of riboflavin was quantified by analysis of absorbance spectra of the cornea collected before and after application of each solution. The mean stromal riboflavin concentration was 0.012% ± 0.003% (SD), 0.0005% ± 0.0003% (P dextran-enriched, 15% dextran-enriched, and hypotonic dextran-free solutions, respectively. The difference of stromal riboflavin concentration between the 2 transepithelial solutions was statistically significant (P Dextran-enriched solutions required complete corneal deepithelialization to permit effective stromal soaking with riboflavin. Nevertheless, riboflavin in hypotonic dextran-free solution with enhancers permeates across stroma through an intact epithelium. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Mydriatics release from solid and semi-solid ophthalmic formulations using different in vitro methods.

Science.gov (United States)

Pescina, Silvia; Macaluso, Claudio; Gioia, Gloria Antonia; Padula, Cristina; Santi, Patrizia; Nicoli, Sara

2017-09-01

The aim of the present paper was the development of semi-solid (hydrogels) and solid (film) ophthalmic formulations for the controlled release of two mydriatics: phenylephrine and tropicamide. The formulations - based on polyvinylalcohol and hyaluronic acid - were characterized, and release studies were performed with three different in vitro set-ups, i.e. Franz-type diffusion cell, vial method and inclined plane; for comparison, a solution and a commercial insert, both clinically used to induce mydriasis, were evaluated. Both gels and film allowed for a controlled release of drugs, appearing a useful alternative for mydriatics administration. However, the release kinetic was significantly influenced by the method used, highlighting the need for optimization and standardization of in vitro models for the evaluation of drug release from ophthalmic dosage forms.

76 FR 28045 - Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% Was Not Withdrawn From Sale for...

Science.gov (United States)

2011-05-13

... marketing for reasons other than safety or effectiveness. ANDAs that refer to XIBROM (bromfenac ophthalmic... Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve...

Long term safety and tolerability of Tafluprost 0.0015% vs Timolol 0.1% preservative-free in ocular hypertensive and in primary open-angle glaucoma patients: a cross sectional study.

Science.gov (United States)

Rolle, Teresa; Spinetta, Roberta; Nuzzi, Raffaele

2017-08-03

The effects of preservatives of antiglaucoma medications on corneal surface and tear function have been widely shown in literature; it's not the same as regards the active compounds themselves. The purpose of our study was to compare Ocular Surface Disease (OSD) signs and symptoms of Tafluprost 0.0015% versus preservative free (PF) Timolol 0.1% eyedrops in ocular hypertensive (OH) and in primary open-angle glaucoma (POAG) patients. A cross-sectional study included patients in monotherapy for at least 36 months with Tafluprost 0.0015% (27) or PF Timolol 0.1% (24) and 20 healthy age and sex-matched volunteers. All subjects underwent clinical tests (Schirmer I and break-up time), in vivo confocal microscopy (IVCM) and were surveyed using Ocular Surface Disease Index (OSDI) and Glaucoma Symptoms Scale (GSS) questionnaires. The groups were compared with ANOVA, Kruskal-Wallis test, t-test, Mann-Whitney test and Bonferroni's adjustment of p-values. No significant differences were found in questionnaires scores, clinical tests, IVCM variables between therapy groups. Tafluprost 0.0015% group showed significantly higher OSDI score, basal epithelial cells density, stromal reflectivity, sub-basal nerves tortuosity (p = 0.0000, 0.037, 0.006, 0.0000) and less GSS score, number of sub-basal nerves (p = 0.0000, 0.037) than controls but similar clinical tests results (p > 0.05). PF Timolol group had significantly higher OSDI score, basal epithelial cells density, stromal reflectivity and sub-basal nerve tortuosity (p = 0.000, 0.014, 0.008, 0.002), less GSS score, BUT and number of sub-basal nerves (p = 0.0000, 0.026, 0.003) than controls. Compared to PF Timolol 0.1%, Tafluprost 0.0015% showed similar safety with regards to tear function and corneal status and a similar tolerability profile. Both therapy groups show some alterations in corneal microstructure but no side effects on tear function except for an increased tear instability in PF Timolol 0.1% group

Ophthalmic masquerades of the atherosclerotic carotids

Directory of Open Access Journals (Sweden)

Anupriya Arthur

2014-01-01

Full Text Available Patients with carotid atherosclerosis can present with ophthalmic symptoms. These symptoms and signs can be due to retinal emboli, hypoperfusion of the retina and choroid, opening up of collateral channels, or chronic hypoperfusion of the globe (ocular ischemic syndrome. These pathological mechanisms can produce many interesting signs and a careful history can bring out important past symptoms pointing toward the carotid as the source of the patient′s presenting symptom. Such patients are at high risk for an ischemic stroke, especially in the subsequent few days following their first acute symptom. It is important for clinicians to be familiar with these ophthalmic symptoms and signs caused by carotid atherosclerosis for making an early diagnosis and to take appropriate measures to prevent a stroke. This review elaborates the clinical features, importance, and implications of various ophthalmic symptoms and signs resulting from atherosclerotic carotid artery disease.

21 CFR 886.4350 - Manual ophthalmic surgical instrument.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual ophthalmic surgical instrument. 886.4350 Section 886.4350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor...

Efficacy and tolerability of fixed-combination brinzolamide/timolol in Latin American patients with open-angle glaucoma or ocular hypertension previously on brimonidine/timolol fixed combination.

Science.gov (United States)

Alezzandrini, Arturo; Hubatsch, Douglas; Alfaro, Rene

2014-09-01

Fixed-combination glaucoma medications are commonly used to achieve target intraocular pressure (IOP) reduction in patients uncontrolled with monotherapy; however, ocular discomfort associated with eye drops can decrease adherence. This study assessed the efficacy and tolerability of twice-daily fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) in Latin American patients transitioned from fixed-combination brimonidine 0.2%/timolol 0.5% (BRIM/TIM-FC) because of insufficient IOP control or treatment intolerance. This 8-week, open-label, prospective study was conducted at six sites in Argentina, Chile, and Mexico. Enrolled patients were aged ≥18 years with open-angle glaucoma (including primary, exfoliative, or pigment-dispersion glaucoma) or ocular hypertension with IOP of 19-35 mmHg in ≥1 eye at baseline (on BRIM/TIM-FC). Patients self-administered BRINZ/TIM-FC to both eyes at 8 a.m. and 8 p.m. daily for 8 weeks. The primary and secondary efficacy endpoints were mean IOP change from baseline at week 8 and percentage of patients achieving target IOP (≤18 mmHg) at week 8, respectively. Exploratory endpoints included patient and investigator preference for treatment at week 8. Adverse events (AEs) were assessed as the safety endpoint. Fifty patients (mean ± SD age, 66.7 ± 11.5 years) received BRINZ/TIM-FC, and 49 were included in the intent-to-treat population. Mean ± SD IOP was significantly reduced from baseline after 8 weeks of treatment with BRINZ/TIM-FC (-3.6 ± 3.0 mmHg; P Wilcoxon signed-rank test; 17.1% reduction). Overall, 55.3% of patients achieved IOP ≤18 mmHg at week 8. Significantly more patients (89.4%) and investigators (95.7%) preferred BRINZ/TIM-FC to BRIM/TIM-FC (both P test). Of the 13 AEs observed, 8 were related to BRINZ/TIM-FC; the most common treatment-related AEs were eye irritation (n = 4) and abnormal sensation in the eye (n = 2). BRINZ/TIM-FC provides an effective and well-tolerated treatment

To study the existing system of surgical safety for cataract surgery at tertiary care ophthalmic centre to implement WHO surgical safety checklist

OpenAIRE

Ruchi Garg; Neeraj Garg; Shakti Kumar Gupta; J. S. Titiyal; R. Mahesh

2016-01-01

Background: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, named after the first President of India, was established on the 10th of March, 1967 as a National centre for ophthalmic science, to provide state of the art patient care, expand human resources for medical education and undertake research to find solutions to eye health problems of national importance. Average numbers of cataract surgeries performed per month are 700 to 1000. Methods: Anticipating implementation in 50% cases...

Treatment of neuro-ophthalmic sarcoidosis.

Science.gov (United States)

Frohman, Larry P

2015-03-01

Because of the rarity of neuro-ophthalmic sarcoidosis, there are no therapeutic guidelines based on evidence-based medicine for this disorder. Review of literature combined with personal experience. Corticosteroids are the preferred initial therapy for neuro-ophthalmic sarcoidosis. If patients cannot tolerate the requisite dose of corticosteroid needed to control their disease, or if corticosteroids fail to adequately control the disease process, the choices of a second agent are based on the consideration of rapidity of clinical response and the safety profile. Although methotrexate and mycophenolate mofetil are the medications that are often selected after corticosteroid failure, more rapidly acting agents that have been used are infliximab and intravenous cyclophosphamide.

Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

Directory of Open Access Journals (Sweden)

Shusaku Ishikawa

2008-09-01

Full Text Available Shusaku Ishikawa1, Yoshimi Nakamura1, Yuko Nakamura1, Hiroshi Sakai1, Shoichi Sawaguchi1, Kazuo Terashima2, Makoto Kanno2, Hidetoshi Yamashita21Department of Ophthalmology, University of the Ryukyus Faculty of Medicine, Okinawa, Japan; 2Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine, Yamagata, JapanPurpose: To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG or ocular hypertension (OH after a change from timolol in combination therapy with latanoprost.Methods: A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SDy] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol. Intraocular pressure (IOP was measured at baseline, 4, 8, and 12 weeks. Blood pressure (BP, pulse rate (PR, and adverse events were also recorded.Results: IOPs at baseline, 4, 8, and 12 weeks were 18.6 ± 2.1 mmHg, 17.8 ± 2.6 mmHg, 17.4 ± 2.5 mmHg, and 17.3 ± 3.5 mmHg, respectively. IOP reduction at 4 and 8 weeks was statistically significant (p < 0.05. The PR was significantly increased at 12 weeks (p < 0.01, but BP was not significantly affected. Four ocular adverse events were noted, but all were mild and transient.Conclusions: Substituting brinzolamide 1% for timolol 0.5% in combination therapy with latanoprost 0.005% demonstrated significant IOP reduction with improvement in PR with POAG or OH. Combination therapy using latanoprost and brinzolamide may be recommended for better IOP control with fewer systemic adverse events.Keywords: open-angle glaucoma, brinzolamide/latanprost combination therapy, timolol/latanoprost combination therapy, intraocular pressure

Audit of Referrals to an Ophthalmic Outpatient Clinic of a Tertiary ...

African Journals Online (AJOL)

Objectives: To determine the referral pattern and assess the quality and accuracy of referral letters to the ophthalmic outpatient clinic of University of Nigeria Teaching Hospital, Enugu. Methods: This study is a prospective cross-sectional survey of all new ophthalmic referrals to the ophthalmic outpatient clinic at University of ...

Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes

Directory of Open Access Journals (Sweden)

Morris TW

2011-09-01

Full Text Available Timothy W Morris1, Lynne S Gearinger1, Dale W Usner2, Michael R Paterno2, Heleen H DeCory3, Timothy L Comstock3, Wolfgang Haas11Microbiology and Sterilization Sciences, 2Clinical Affairs, 3Global Pharmaceutical Medical Affairs, Bausch & Lomb, Rochester, NY, USAPurpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5% were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE to investigate the cause of eradication failures and the potential for drug resistance development.Results: Visit 2 (day 4 or 5 and visit 3 (day 8 overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to

Dendritiform Keratopathy Associated with Exposure to Polyquarternium-1, a Common Ophthalmic Preservative.

Science.gov (United States)

Matoba, Alice Y; Peterson, Jeff R; Wilhelmus, Kirk R

2016-03-01

To describe dendritiform keratopathy associated with exposure to polyquaternium-1, a common preservative found in contact lens solutions and tear replacement products. Case series. Sixteen patients who demonstrated dendritiform keratopathy during topical ophthalmic exposure to polyquaternium-1. Records were reviewed of all patients diagnosed with dendritiform keratopathy between 1999 and 2014 who had documented exposure to contact lens care disinfecting solutions or artificial tear solutions containing polyquaternium-1. Patients were excluded who had coexisting potential causes for dendritiform keratopathy, such as prior herpes simplex keratitis, varicella-zoster viral keratitis, the linear form of Thygeson's superficial keratitis, epithelial regeneration line, Acanthamoeba keratitis, mucus plaque keratopathy, medication-related keratopathy, or limbal stem cell deficiency characterized by conjunctivalization of the corneal epithelium. Effect of discontinuation of exposure to polyquaternium-1 on the dendritiform keratopathy. Sixteen patients demonstrated dendritiform keratopathy after exposure to the preservative polyquaternium-1. Thirteen patients had a history of recent exposure to contact lens disinfecting solutions (Opti-Free, Equate) containing polyquaternium-1. Three patients used a tear replacement product (Systane) containing a polyquaternium-1 preservative. Four patients were treated with antiviral medications for presumed herpes simplex keratitis; 4 patients underwent diagnostic testing for Acanthamoeba keratitis. Two additional patients were diagnosed sequentially with herpes simplex keratitis, then Acanthamoeba keratitis before referral. All dendritiform lesions resolved within 2 to 6 weeks after elimination of exposure to polyquaternium-1. Ophthalmic products containing polyquaternium-1 may cause dendritiform keratopathy that may be confused with infections of the superficial cornea, such as herpes simplex virus keratitis or Acanthamoeba keratitis

Retinal protective effects of topically administered agmatine on ischemic ocular injury caused by transient occlusion of the ophthalmic artery

Science.gov (United States)

Hong, S.; Hara, H.; Shimazawa, M.; Hyakkoku, K.; Kim, C.Y.; Seong, G.J.

2012-01-01

Agmatine, an endogenous polyamine and putative neuromodulator, is known to have neuroprotective effects on various neurons in the central nervous system. We determined whether or not topically administered agmatine could reduce ischemic retinal injury. Transient ocular ischemia was achieved by intraluminal occlusion of the middle cerebral artery of ddY mice (30-35 g) for 2 h, which is known to also induce occlusion of the ophthalmic artery. In the agmatine group (N = 6), a 1.0 mM agmatine-containing ophthalmic solution was administered four times daily for 2 weeks before occlusion. In the control group (N = 6), a 0.1% hyaluronic acid ophthalmic solution was instilled at the same times. At 22 h after reperfusion, the eyeballs were enucleated and the retinal sections were stained by terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL). Transient ocular ischemia induced apoptosis of retinal cells in the entire retinal layer, and topically administered agmatine can significantly reduce this ischemic retinal injury. The proportion of apoptotic cells was definitely decreased (P agmatine application effectively decreases retinal damage in an in vivo ocular ischemic injury model. This implies that agmatine is a good candidate as a direct neuroprotective agent for eyes with ocular ischemic diseases. PMID:22331138

Aqueous Humor Penetration and Biological Activity of Moxifloxacin 0.5% Ophthalmic Solution Alone or with Dexamethasone 0.1.

Science.gov (United States)

Gomes, Rachel L R; Viana, Rodrigo Galvão; Melo, Luiz Alberto S; Cruz, Alessandro Carvalho; Suenaga, Eunice Mayumi; Kenyon, Kenneth R; Campos, Mauro

2017-03-01

To compare aqueous humor concentrations of topically applied moxifloxacin 0.5% ophthalmic solution alone or in combination with dexamethasone 0.1% and to correlate these concentrations with the minimum inhibitory concentrations (MICs) for common endophthalmitis-causing organisms. Sixty-eight patients undergoing routine phacoemulsification with intraocular lens implantation received either moxifloxacin 0.5% alone or moxifloxacin 0.5% combined with dexamethasone. For both groups, 1 drop of the test solution was instilled 4 times daily 1 day preoperatively and 1 drop 1 h preoperatively. An aqueous humor sample obtained immediately before paracentesis was submitted to high-performance liquid chromatography-tandem mass spectrometry to determine the moxifloxacin concentration. The mean concentrations of moxifloxacin were 986.6 ng/mL in the moxifloxacin with dexamethasone group and 741.3 ng/mL in the moxifloxacin group (P = 0.13). Moxifloxacin concentrations of all samples exceeded the MICs for Staphylococcus epidermidis, S. aureus, and Streptococcus pneumoniae. All samples in the moxifloxacin with dexamethasone group and 94% in the moxifloxacin group achieved the MIC for Enterococcus species. For quinolone-resistant S. aureus, the MIC was achieved in 29% in the moxifloxacin with dexamethasone group and 9% in the moxifloxacin group (P = 0.06). Aqueous humor moxifloxacin concentrations were higher when topically administrated in combination with dexamethasone compared to the moxifloxacin alone. However, this difference was not statistically significant. Nevertheless, the MICs of the most common pathogens associated with endophthalmitis were exceeded in both study groups.

Allergic Contact Dermatitis to Ophthalmic Medications: Relevant Allergens and Alternative Testing Methods.

Science.gov (United States)

Grey, Katherine R; Warshaw, Erin M

Allergic contact dermatitis is an important cause of periorbital dermatitis. Topical ophthalmic agents are relevant sensitizers. Contact dermatitis to ophthalmic medications can be challenging to diagnose and manage given the numerous possible offending agents, including both active and inactive ingredients. Furthermore, a substantial body of literature reports false-negative patch test results to ophthalmic agents. Subsequently, numerous alternative testing methods have been described. This review outlines the periorbital manifestations, causative agents, and alternative testing methods of allergic contact dermatitis to ophthalmic medications.

Readability assessment of online ophthalmic patient information.

Science.gov (United States)

Edmunds, Matthew R; Barry, Robert J; Denniston, Alastair K

2013-12-01

Patients increasingly use the Internet to access information related to their disease, but poor health literacy is known to impact negatively on medical outcomes. Multiple agencies have recommended that patient-oriented literature be written at a fourth- to sixth-grade (9-12 years of age) reading level to assist understanding. The readability of online patient-oriented materials related to ophthalmic diagnoses is not yet known. To assess the readability of online literature specifically for a range of ophthalmic conditions. Body text of the top 10 patient-oriented websites for 16 different ophthalmic diagnoses, covering the full range of ophthalmic subspecialties, was analyzed for readability, source (United Kingdom vs non-United Kingdom, not for profit vs commercial), and appropriateness for sight-impaired readers. Four validated readability formulas were used: Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), and Gunning Fog Index (GFOG). Data were compared with the Mann-Whitney test (for 2 groups) and Kruskal-Wallis test (for more than 2 groups) and correlation was assessed by the Spearman r. None of the 160 webpages had readability scores within published guidelines, with 83% assessed as being of "difficult" readability. Not-for-profit webpages were of significantly greater length than commercial webpages (P = .02) and UK-based webpages had slightly superior readability scores compared with those of non-UK webpages (P = .004 to P readability formula used). Of all webpages evaluated, only 34% included facility to adjust text size to assist visually impaired readers. To our knowledge, this is the first study to assess readability of patient-focused webpages specifically for a range of ophthalmic diagnoses. In keeping with previous studies in other medical conditions, we determined that readability scores were inferior to those recommended, irrespective of the measure used. Although readability is only one

Bilateral IgG4-related ophthalmic disease: a strong indication for systemic imaging.

Science.gov (United States)

Wu, Albert; Andrew, Nicholas H; McNab, Alan A; Selva, Dinesh

2016-10-01

To investigate whether bilateral or unilateral IgG4-related ophthalmic disease (IgG4-ROD) is associated with extra-ophthalmic IgG4-related disease (IgG4-RD). Twin-centre retrospective observational case series of biopsy-confirmed IgG4-ROD. Clinical and radiology data were reviewed for laterality of IgG4-ROD and presence of extra-ophthalmic disease. The literature was reviewed for case series of IgG4-ROD. 40 IgG4-ROD cases were identified, with median follow-up of 36 months. At diagnosis of IgG4-ROD, all cases were screened for extra-ophthalmic disease with physical examination and blood testing. Systemic imaging was performed in 20 (50%) cases due to clinical suspicion of extra-ophthalmic disease. Of the 21 unilateral IgG4-ROD cases, 3 (14%) had extra-ophthalmic involvement. Of the 19 bilateral cases, 15 (79%) had extra-ophthalmic involvement. Extra-ophthalmic involvement was strongly associated with bilateral IgG4-ROD (pIgG4-ROD is strongly associated with extra-ophthalmic IgG4-RD. We recommend that imaging of the neck, chest, abdomen and pelvis be performed for all bilateral cases. Systemic imaging should also be considered in unilateral cases as a significant proportion of these patients will also have extra-ophthalmic disease. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

21 CFR 524.1193 - Ivermectin topical solution.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Ivermectin topical solution. 524.1193 Section 524...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1193 Ivermectin topical solution. (a) Specifications. Each milliliter (mL) of solution contains 5 milligrams of...

ANALYSIS OF BETAMETHASONE DISODIUM PHOSPHATE INJECTION AND OPHTHALMIC SOLUTION BY HPLC, KINETIC INTERPRETATION AND DETERMINATION OF SHELF LIFE

Directory of Open Access Journals (Sweden)

A. Ghanbarpour

1994-07-01

Full Text Available Corticosteroids are widely used in therapeutics in different formulations. Betamethasone disodium phosphate is one of the most soluble of the adrenocorticosteroidal agents. It is therefore very suitable for intravenous use and particularly for ophthalmic formulations."nAcceleration method is used to determine expiration date of aqueous formulations manufactured in Iran.

In vivo evaluation and in-depth pharmaceutical characterization of a rapidly dissolving solid ocular matrix for the topical delivery of timolol maleate in the rabbit eye model.

Science.gov (United States)

Moosa, Raeesa M; Choonara, Yahya E; du Toit, Lisa C; Tomar, Lomas K; Tyagi, Charu; Kumar, Pradeep; Carmichael, Trevor R; Pillay, Viness

2014-05-15

The purpose of this study was to investigate the in-depth pharmaceutical properties and in vivo behavior of a novel lyophilized rapidly dissolving solid ocular matrix (RD-SOM) as a 'solid eye drop' formulation comprising timolol maleate as the model drug. Thermal and molecular transition analysis displayed similar findings with no incompatibility between formulation components. Porositometric studies confirmed the presence of interconnecting pores across the matrix surface. The HETCAM test indicated an irritation score of 0 with the inference of good tolerability for the RD-SOM in the New Zealand White albino rabbit eye model. Ex vivo permeation across excised rabbit cornea showed an improved steady state drug flux (0.00052 mg cm(-2)min(-1)) and permeability co-efficient (1.7 × 10(-4)cmmin(-1)) for the RD-SOM compared to pure drug and a marketed eye drop preparation. UPLC analysis quantitatively separated timolol maleate and the internal standard (diclofenac sodium) and gamma irradiation was used as a terminal sterilization procedure. In vivo results revealed a peak concentration of timolol was reached at 104.9 min. In the case of a typical eye drop formulation a lower Cmax was obtained (1.97 ug/mL). Level A point-to-point IVIVC plots via the Wagner-Nelson method revealed a satisfactory R(2) value of 0.84. In addition, the biodegradability and ocular compatibility of the RD-SOM was confirmed by histopathological toxicity studies. Copyright © 2014 Elsevier B.V. All rights reserved.

Medical physics aspects of ophthalmic brachytherapy

International Nuclear Information System (INIS)

Sharma, S.D.; Shanta, A.; Palani Selvam, T.; Tripathi, U.B.; Bhatt, B.C.

2004-11-01

Intraocular melanoma is the most common primary malignancy of the eye. Radiation therapy using ophthalmic plaque has proved successful in the management of various ocular lesions. Although a few centres were using 90 Sr/ 90 Y plaques for shallow turtlours some years ago, eye plaque therapy was not a common practice in India. A revived interest in the use of eye plaque therapy and very high cost of imported sources has led to the development and production of 125 I seed sources by the Radiopharmaceuticals Division, BARC. This report presents a brief description on the clinical, dosimetry and radiation safety aspects of 90 Sr/ 90 Y and 106 Ru/ 106 Rh beta ray and 125 I gamma ray eye plaque applicators. This report has been divided in five Sections. Section I presents general introduction of ophthalmic brachytherapy including the structure of a human eye, types of ophthalmic plaques and characteristics of radioisotopes commonly used in such applications. A brief review of sources, applicators and dosimetry of 90 Sr/ 90 Y and 106 Ru/ 106 Rh beta and 125 I gamma ophthalmic plaques are given in Section II and Section III, respectively. Section IV contains the single seed dosimetry data of BARC OcuProsta 125 I seed as well as dosimetry data of typical eye plaques loaded with BARC OcuProsta 125 I seed. Quality assurance and radiation safety aspects of these eye applicators are described in Section V. A proforma of the application required to be filled in by the user institution for obtaining regulatory consent to start eye plaque therapy has also been appended to this report. (author)

21 CFR 524.1446 - Milbemycin oxime solution.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Milbemycin oxime solution. 524.1446 Section 524...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 524.1446 Milbemycin oxime solution. (a) Specifications. Each tube contains 0.25 milliliter of a 0.1 percent solution...

Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

OpenAIRE

Baranowski, Przemysław; Karolewicz, Bożena; Gajda, Maciej; Pluta, Janusz

2014-01-01

This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to...

Cerebral Angiographic Findings of Cosmetic Facial Filler-related Ophthalmic and Retinal Artery Occlusion.

Science.gov (United States)

Kim, Yong-Kyu; Jung, Cheolkyu; Woo, Se Joon; Park, Kyu Hyung

2015-12-01

Cosmetic facial filler-related ophthalmic artery occlusion is rare but is a devastating complication, while the exact pathophysiology is still elusive. Cerebral angiography provides more detailed information on blood flow of ophthalmic artery as well as surrounding orbital area which cannot be covered by fundus fluorescein angiography. This study aimed to evaluate cerebral angiographic features of cosmetic facial filler-related ophthalmic artery occlusion patients. We retrospectively reviewed cerebral angiography of 7 patients (4 hyaluronic acid [HA] and 3 autologous fat-injected cases) showing ophthalmic artery and its branches occlusion after cosmetic facial filler injections, and underwent intra-arterial thrombolysis. On selective ophthalmic artery angiograms, all fat-injected patients showed a large filling defect on the proximal ophthalmic artery, whereas the HA-injected patients showed occlusion of the distal branches of the ophthalmic artery. Three HA-injected patients revealed diminished distal runoff of the internal maxillary and facial arteries, which clinically corresponded with skin necrosis. However, all fat-injected patients and one HA-injected patient who were immediately treated with subcutaneous hyaluronidase injection showed preserved distal runoff of the internal maxillary and facial arteries and mild skin problems. The size difference between injected materials seems to be associated with different angiographic findings. Autologous fat is more prone to obstruct proximal part of ophthalmic artery, whereas HA obstructs distal branches. In addition, hydrophilic and volume-expansion property of HA might exacerbate blood flow on injected area, which is also related to skin necrosis. Intra-arterial thrombolysis has a limited role in reconstituting blood flow or regaining vision in cosmetic facial filler-associated ophthalmic artery occlusions.

Retinal protective effects of topically administered agmatine on ischemic ocular injury caused by transient occlusion of the ophthalmic artery

Directory of Open Access Journals (Sweden)

S. Hong

2012-03-01

Full Text Available Agmatine, an endogenous polyamine and putative neuromodulator, is known to have neuroprotective effects on various neurons in the central nervous system. We determined whether or not topically administered agmatine could reduce ischemic retinal injury. Transient ocular ischemia was achieved by intraluminal occlusion of the middle cerebral artery of ddY mice (30-35 g for 2 h, which is known to also induce occlusion of the ophthalmic artery. In the agmatine group (N = 6, a 1.0 mM agmatine-containing ophthalmic solution was administered four times daily for 2 weeks before occlusion. In the control group (N = 6, a 0.1% hyaluronic acid ophthalmic solution was instilled at the same times. At 22 h after reperfusion, the eyeballs were enucleated and the retinal sections were stained by terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL. Transient ocular ischemia induced apoptosis of retinal cells in the entire retinal layer, and topically administered agmatine can significantly reduce this ischemic retinal injury. The proportion of apoptotic cells was definitely decreased (P < 0.001; Kruskal-Wallis test. Overall, we determined that topical agmatine application effectively decreases retinal damage in an in vivo ocular ischemic injury model. This implies that agmatine is a good candidate as a direct neuroprotective agent for eyes with ocular ischemic diseases.

Stability study of azithromycin in ophthalmic preparations

Directory of Open Access Journals (Sweden)

Andréia de Haro Moreno

2009-06-01

Full Text Available A stability study of azithromycin in ophthalmic preparations was developed by submission to different types of light, temperature and pH, using the biodiffusion assay (cylinder 3 x 3 for the quantifications. Bacillus subtilis, ATCC 9372, was used as test organism. The used concentration range was of 50 to 200 µg/mL. The study demonstrated that the drug suffered degradation when submitted to the ultraviolet light, germicide light, solar luminosity, acid solution, basic solution and hydrogen peroxide solution. The results were analyzed by the analysis of variance (ANOVA.O estudo de estabilidade de azitromicina em preparações oftálmicas foi realizado após exposição a diferentes tipos de luz, temperatura e pH, utilizando o método de difusão em ágar (cilindros 3 x 3 para as quantificações. A faixa de concentração foi de 50 a 200 µg/mL. O estudo demonstrou que o fármaco sofreu degradação quando submetido às luzes ultravioleta, germicida e solar, e a soluções ácida, alcalina e de peróxido de hidrogênio. Os resultados foram analisados através da análise da variância (ANOVA.

ANAESTHESIA FOR OPHTHALMIC SURGICAL PROCEDURES

African Journals Online (AJOL)

Objective: To review factors influencing the choice of anaesthesia for ophthalmic surgical procedures. ... as risk associated with general anaesthesia (8) they are more .... Wilson ME, Pandey SK, Thakur J. Paediatric cataract blindness in the ...

Ophthalmic artery color Doppler ultrasonography in mild-to-moderate preeclampsia

International Nuclear Information System (INIS)

Ayaz, Tunahan; Akansel, Gur.; Hayirlioglu, Alper; Arslan, Arzu; Suer, Necdet; Kuru, Ihsan

2003-01-01

Objective: To evaluate the hemodynamic changes in mild-moderate preeclampsia using ophthalmic artery Doppler ultrasonography technique. Methods: Ophthalmic artery pulsatility and resistivity indices were calculated in 30 mild-moderate preeclamptic women and 30 normotensive gravid women of matched gestational age. Student's t-test was performed to test the significance of difference. Results: Both indices of peripheral resistance were found to be significantly lower in the ophthalmic arteries of mild-moderately preeclamptic women than those measured in normotensive gravid women at similar stage of pregnancy. In a small number patients whose disease progressed to severe preeclampsia, both indices increased. Conclusion: In patients with mild-moderate preeclampsia, ophthalmic artery color Doppler ultrasonography detects hemodynamic changes that are not present in normotensive gravid women. Reversal of Doppler patterns in a small number of patients with progressive disease supports the hypotheses suggesting the presence of early vasodilation and late vasospasm in the etiology of preeclampsia

Polymyxin B and Trimethoprim Ophthalmic

Science.gov (United States)

Polymyxin B and trimethoprim ophthalmic combination is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection ... inside and outer parts of the eyelid). Polymyxin B and trimethoprim are in a class of medications ...

Neuro-ophthalmic and clinical characteristics of brain tumours in a ...

African Journals Online (AJOL)

Background: Anecdotally, increasing number of patients are seen at Korle Bu Teaching Hospital (KBTH) with brain tumour. Neuro-ophthalmic symptoms and signs may help in timely diagnosis and intervention. Objective: To evaluate the neuro-ophthalmic and clinical characteristics of brain tumour in patients presenting at a ...

Safety of prophylactic intracameral moxifloxacin ophthalmic solution after cataract surgery in patients with penetrating keratoplasty

Directory of Open Access Journals (Sweden)

Osman Sevki Arslan

2014-10-01

Full Text Available AIM:To determine the safety of prophylactic intracameral moxifloxacin after cataract surgery in patients with penetrating keratoplasty (PKP.METHODS:In this retrospective study of consecutive patients who had phacoemulsification cataract surgery after PKP, were treated with intracameral moxifloxacin 0.5% ophthalmic solution (0.5 mg/0.1 mL. The main outcome measures were anterior chamber reaction, best corrected visual acuity (BCVA, corneal endothelial cell count (ECC, and central corneal thickness (CCT.RESULTS:Fifty-five patients were recruited (26 males, 29 females. The mean age was 54.36±4.97y (range 45-64y. All eyes had improved postoperative BCVA. The mean BCVA was 0.25 preoperatively and 0.57 postoperatively, which was statistically significant (P<0.001. One eye had 3+, 7 eyes had 2+, 12 eyes had 1+ and 8 eyes had trace amount of aqueous cells on the first day after surgery. All eyes had no anterior chamber cells at subsequent follow up examinations. Effective phacoemulsification time was 4.33±1.01s. The mean ECC was 2340.20 cells/mm2 preoperatively and 1948.75 cells/mm2 1mo postoperatively (P<0.001. The increase of 21.09 µm in postoperative pachymetry 1mo after surgery was statistically significant (P<0.001.CONCLUSION: No untoward effects were observed after intracameral injection of moxifloxacin (0.5 mg/0.1 mL in terms of anterior chamber reaction, CCT, ECC, and visual rehabilitation at the conclusion of cataract surgery in patients with PKP.

Ophthalmic artery color Doppler ultrasonography in mild-to-moderate preeclampsia

Energy Technology Data Exchange (ETDEWEB)

Ayaz, Tunahan; Akansel, Gur. E-mail: gakansel@superonline.com; Hayirlioglu, Alper; Arslan, Arzu; Suer, Necdet; Kuru, Ihsan

2003-06-01

Objective: To evaluate the hemodynamic changes in mild-moderate preeclampsia using ophthalmic artery Doppler ultrasonography technique. Methods: Ophthalmic artery pulsatility and resistivity indices were calculated in 30 mild-moderate preeclamptic women and 30 normotensive gravid women of matched gestational age. Student's t-test was performed to test the significance of difference. Results: Both indices of peripheral resistance were found to be significantly lower in the ophthalmic arteries of mild-moderately preeclamptic women than those measured in normotensive gravid women at similar stage of pregnancy. In a small number patients whose disease progressed to severe preeclampsia, both indices increased. Conclusion: In patients with mild-moderate preeclampsia, ophthalmic artery color Doppler ultrasonography detects hemodynamic changes that are not present in normotensive gravid women. Reversal of Doppler patterns in a small number of patients with progressive disease supports the hypotheses suggesting the presence of early vasodilation and late vasospasm in the etiology of preeclampsia.

Comparison between 0.5% timolol maleate and 0.2% brimonidine tartrate in controlling increase in intraocular pressure after neodymium: yttrium-aluminium-garnet laser capsulotomy

International Nuclear Information System (INIS)

Tayyab, H.; Azhar, M.N.; Haider, M.A.; Jahangir, T.

2013-01-01

Objective: To compare the effectiveness of prophylactically given 0.5% Timolol maleate and 0.2% Brimonidine tartrate in controlling increase in intraocular pressure after neodymium (Nd) : yttrium aluminum garnet (YAG) laser capsulotomy. Study Design: Randomized controlled trial. Place and Duration of Study: This study was conducted at Ophthalmology Department, Jinnah Hospital, Lahore from 15-05-2009 to 14-05-2010 for a duration of 12 months. Material and Methods: In this study, 90 consecutive patients were referred from outpatient department for Nd: YAG laser capsulotomy. Hospital ethical committee's approval for this research proposal and the informed consent was taken. These patients were equally divided into two groups A and B, comprising of 45 patients in each group. Group A was control group which received 0.5% Timolol maleate. Group B was experimental group which received 0.2% Brimonidine tartrate. Intraocular pressure was measured using Goldmann tonometer before instilling these topical medications. These medications were administered topically 1 hour before the laser procedure. Intraocular pressure (IOP) was recorded 1 and 3 hours after laser capsulotomy. Results: In patients belonging to group A, 42 (93.3%) patients had effective control of IOP (raise of less than or equal to 5 mmHg from the baseline) after 3 hours of Nd:YAG laser capsulotomy whereas 28 (62.2%) patients had effective control of IOP after the same period of time in group-B with significant difference (p<0.001). Conclusion: Use of prophylactic topical antiglaucoma medications before doing Nd: YAG laser capsulotomy is a effective way to reduce post laser spike of intraocular pressure. Present study showed that the use of 0.5% timolol maleate was safe and more effective than 0.2% brimonidine tartrate when given 1 hour before laser capsulotomy. (author)

Limitations when use chloramphenicol-bcyclodextrins complexes in ophtalmic solutions buffered with boric acid/borax system

Directory of Open Access Journals (Sweden)

Todoran Nicoleta

2014-12-01

Full Text Available Chloramphenicol eye drops are commonly prescribed in concentrations of 0.5-1% in the treatment of infectious conjunctivitis. In terms of ophthalmic solution preparation, the major disadvantage of chloramphenicol consists in its low solubility in water. The solubility is increased by substances that form chloramphenicol-complexes, for example: boric acid/borax or cyclodextrins. Objective: Experimental studies aimed to evaluate the potential advantages of enhancing the solubility and stability of chloramphenicol (API by molecular encapsulation in b-cyclodextrin (CD, in formulation of ophthalmic solutions buffered with boric acid/borax system. Methods and Results: We prepared four APIb- CD complexes, using two methods (kneading and co-precipitation and two molar ratio of API/b-cyclodextrin (1:1 and 1:2. The formation of complexes was proved by differential scanning calorimetry (DSC and the in vitro dissolution tests. Using these compounds, we prepared eight ophthalmic solutions, formulated in two variants of chloramphenicol concentrations (0.4% and 0.5%. Each solution was analyzed, by the official methods, at preparation and periodically during three months of storing in different temperature conditions (4°C, 20°C and 30°C. Conclusions: Inclusion of chloramphenicol in b-cyclodextrin only partially solves the difficulties due to the low solubility of chloramphenicol. The protection of chloramphenicol molecules is not completely ensured when the ophthalmic solutions are buffered with the boric acid/borax system.

The assessment of visually impaired persons working capacities using electrophysiological and ophthalmic ergonomics methods

Directory of Open Access Journals (Sweden)

M. I. Razumovsky

2014-07-01

Full Text Available Aim was to analyze working capacities of visually impaired persons by means of complex electrophysiological and ophthalmic ergonomics eye examination.Materials and methods. Standard clinical ophthalmologic examination (visual acuity measurement, refractometry, biomicroscopy, ophthalmoscopy as well as electrophysiological (electrooculography, electrical sensitivity of the eye, critical flicker fusion frequency and ophthalmic ergonomics tests (accommodation measurement, professional testing using automated system «Proftest-1» were performed.Results. Complex electrophysiological and ophthalmic ergonomics tests were performed in 20 visually impaired persons. Their results revealed direct correlation between electrophysiological and ophthalmic ergonomics indices.Conclusion. Working capacities of visually impaired persons can be assessed reliably using complex electrophysiological and ophthalmic ergonomics eye examination only.

The assessment of visually impaired persons working capacities using electrophysiological and ophthalmic ergonomics methods

Directory of Open Access Journals (Sweden)

M. I. Razumovsky

2014-01-01

Full Text Available Aim was to analyze working capacities of visually impaired persons by means of complex electrophysiological and ophthalmic ergonomics eye examination.Materials and methods. Standard clinical ophthalmologic examination (visual acuity measurement, refractometry, biomicroscopy, ophthalmoscopy as well as electrophysiological (electrooculography, electrical sensitivity of the eye, critical flicker fusion frequency and ophthalmic ergonomics tests (accommodation measurement, professional testing using automated system «Proftest-1» were performed.Results. Complex electrophysiological and ophthalmic ergonomics tests were performed in 20 visually impaired persons. Their results revealed direct correlation between electrophysiological and ophthalmic ergonomics indices.Conclusion. Working capacities of visually impaired persons can be assessed reliably using complex electrophysiological and ophthalmic ergonomics eye examination only.

Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

Directory of Open Access Journals (Sweden)

Przemysław Baranowski

2014-01-01

Full Text Available This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to defense mechanisms of the human eye, extending contact time of drug with the cornea, increasing the penetration through the complex anatomical structure of the eye, and providing controlled release of drugs into the eye tissues, which allows reducing the drug application frequency. The rest of the paper describes recommended in vitro and in vivo studies to be performed for various ophthalmic drugs forms in order to assess whether the form is acceptable from the perspective of desired properties and patient’s compliance.

Challenges Encountered Using Ophthalmic Anesthetics in Space Medicine

Science.gov (United States)

Bayuse, T.; Law, J.; Alexander, D.; Moynihan, S.; LeBlanc, C.; Langford, K.; Magalhaes, L.

2015-01-01

On orbit, ophthalmic anesthetics are used for tonometry and off-nominal corneal examinations. Proparacaine has been flown traditionally. However, the manufacturers recently changed its storage requirements from room temperature storage to refrigerated storage to preserve stability and prolong the shelf-life. Since refrigeration on orbit is not readily available and there were stability concerns about flying proparacaine unrefrigerated, tetracaine was selected as an alternative ophthalmic anesthetic in 2013. We will discuss the challenges encountered flying and using these anesthetics on the International Space Station.

The international council of ophthalmology: vision for ophthalmic education in an interdependent world.

Science.gov (United States)

Lee, Andrew G; Golnik, Karl C; Tso, Mark O M; Spivey, Bruce; Miller, Kathleen; Gauthier, Tina-Marie

2012-10-01

To describe the emerging strategic global perspective of the International Council of Ophthalmology (ICO) efforts in ophthalmic education. A global perspective describing how the development of sophisticated educational tools in tandem with information technology can revolutionize ophthalmic education worldwide. Review of ICO educational tools, resources, and programs that are available to ophthalmic educators across the globe. With the explosive growth of the Internet, the ability to access medical information in the most isolated of locations is now possible. Through specific ICO initiatives, including the ICO curricula, the "Teaching the Teachers" program, and the launching of the new ICO Center for Ophthalmic Educators, the ICO is providing ophthalmic educators across the globe with access to standardized but customizable educational programs and tools to better train ophthalmologists and allied eye care professionals throughout the world. Access to educational tools and strengthening of global learning will help providers meet the goals of VISION 2020 and beyond in eliminating avoidable blindness. It is the intent of the ICO that its programs for ophthalmic educators, including conferences, courses, curricula, and online resources, result in better-trained ophthalmologists and eye care professionals worldwide. Copyright © 2012 Elsevier Inc. All rights reserved.

Cerebral Angiographic Findings of Cosmetic Facial Filler-related Ophthalmic and Retinal Artery Occlusion

OpenAIRE

Kim, Yong-Kyu; Jung, Cheolkyu; Woo, Se Joon; Park, Kyu Hyung

2015-01-01

Cosmetic facial filler-related ophthalmic artery occlusion is rare but is a devastating complication, while the exact pathophysiology is still elusive. Cerebral angiography provides more detailed information on blood flow of ophthalmic artery as well as surrounding orbital area which cannot be covered by fundus fluorescein angiography. This study aimed to evaluate cerebral angiographic features of cosmetic facial filler-related ophthalmic artery occlusion patients. We retrospectively reviewed...

Risk factors of ophthalmic disorders in children with developmental delay

DEFF Research Database (Denmark)

Sandfeld, L.N.; Jensen, H.; Skov, L.

2008-01-01

PURPOSE: To identify diagnoses that increase the risk of ophthalmic disorders in developmentally delayed children. METHODS: A cross-sectional study of 1126 Danish children with developmental delay (IQ Udgivelsesdato: 2008/12......PURPOSE: To identify diagnoses that increase the risk of ophthalmic disorders in developmentally delayed children. METHODS: A cross-sectional study of 1126 Danish children with developmental delay (IQ Udgivelsesdato: 2008/12...

21 CFR 524.1662 - Oxytetracycline hydrochloride ophthalmic and topical dosage forms.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride ophthalmic and topical dosage forms. 524.1662 Section 524.1662 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... DOSAGE FORM NEW ANIMAL DRUGS § 524.1662 Oxytetracycline hydrochloride ophthalmic and topical dosage forms. ...

International Council of Ophthalmology: Refocusing Ophthalmic Education in the Asia-Pacific Region and Beyond.

Science.gov (United States)

Golnik, Karl; Mayorga, Eduardo; Spivey, Bruce; Ritch, Robert; Gauthier, Tina-Marie

2012-01-01

The International Council of Ophthalmology (ICO) is a global organization with a regional focus. Working in partnership with supranational and ICO member societies, the ICO is building a "World Alliance for Sight" to improve access to the highest-quality eye care worldwide. Designed to preserve and restore vision on an international scale, the ICO initiative, "Refocusing Ophthalmic Education," enhances ophthalmic education of residents, subspecialists, medical students, and allied eye care personnel by redefining the most effective ways to teach and in creating beneficial educational opportunities. The "Teaching the Teachers" program helps ophthalmic educators incorporate more effective methods of training and continuing professional development to meet societal needs, achieved in part through regional courses for residency program directors; symposia, and keynote talks presented by ICO's World Ophthalmology Educational Colloquium, Conferences for Ophthalmic Educators, and ophthalmic surgical competency rubrics. Recognizing that standardized curricula are essential for consistent ophthalmic education, the ICO has developed a curricular framework whereby goals, expectations, knowledge base, competencies, and technical training are delineated. The ICO is defining worldwide models of team training and compiling best practice, which will include training-program accreditation to ensure improvement in the education of ophthalmologists. International Council of Ophthalmology Web-based teaching courses, a Webinar Network, and a technology blog further support information and communication technologies for teaching and learning. At the ICO's Center for Ophthalmic Educators (educators.icoph.org), trainers will find valuable teaching resources in multiple languages as well as ways to share ideas and collaborate with peers and other ophthalmic educators.

Clinical evaluation of the effect of diquafosol ophthalmic solution in glaucoma patients with dry eye syndrome.

Science.gov (United States)

Jin, Sang Wook; Min, Ji Sang

2016-05-01

To investigate the effects of diquafosol on intraocular pressure (IOP) and dry eye symptoms in glaucoma patients with dry eye syndrome (DES). This study evaluated a total of 138 glaucoma patients with DES who were treated with diquafosol ophthalmic solution (DIQUAS(®)). Before treatment and 1, 4, 12, 36, and 52 weeks after treatment, IOP, ocular surface disease index (OSDI), tear film break-up time (BUT), Schirmer I test scores, fluorescein staining, conjunctival impression cytology, and adverse drug reactions were evaluated. Throughout the treatment period, the mean IOP for all the patients remained stable after treatment with diquafosol (15.4 ± 2.8 mmHg at baseline and 16.0 ± 2.8 mmHg at 52 weeks). The mean OSDI score improved significantly at 4, 12, and 52 weeks after diquafosol treatment. The BUT and Schirmer I test scores were significantly increased after diquafosol treatment. The Oxford scheme score was significantly decreased at 1, 4, 12, 36, and 52 weeks after diquafosol treatment. A significant improvement in goblet cell density was observed after 4 weeks of treatment with diquafosol. Adverse drug reactions were reported in 22 (15.9 %) patients. There were no serious adverse drug reactions. Diquafosol was effective in improving objective and subjective symptoms and maintained a stable IOP in glaucoma patients with DES. Therefore, the addition of diquafosol treatment in glaucoma patients with DES or ocular surface side effects using anti-glaucoma medication may be beneficial.

Comparison of the effectiveness of contemporary ophthalmic lenses against β radiation

International Nuclear Information System (INIS)

Dunlap, J.H.; Harvey, P.W.; Schwing, R.L.

1977-01-01

As part of a study intended to identify the lens material and type that provides maximum eye protection against beta radiation, the effectiveness of contemporary ophthalmic lenses has been evaluated. From the calculations and measurements presented it is evident that safety glasses with crown glass ophthalmic lenses afford the eye the greatest protection against beta radiation, whereas street glasses with plastic ophthalmic lenses afford the eye very little protection. It is to be noted that glass street lenses (approximately 2.2 mm thick) provide greater protection than plastic safety lenses (approximately 3.5 mm thick). A warning is given against the use of safety lenses containing a large percentage of thorium. (U.K.)

Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma.

Science.gov (United States)

Walimbe, Tejaswini; Chelerkar, Vidya; Bhagat, Purvi; Joshi, Abhijeet; Raut, Atul

2016-01-01

Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F2α, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (Preduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed. Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI(©) score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK-free latanoprost was well tolerated with only mild-to-moderate and self-limiting AEs. BAK-free latanoprost appears to be effective in protecting ocular surface integrity in glaucoma patients but further studies are needed to confirm this beneficial effect.

Systemic absorption and adverse ocular and systemic effects after topical ophthalmic administration of 0.1% diclofenac to healthy cats.

Science.gov (United States)

Hsu, Kimberly K; Pinard, Chantale L; Johnson, Ron J; Allen, Dana G; KuKanich, Butch K; Nykamp, Stephanie G

2015-03-01

To quantify plasma concentrations and determine adverse ocular, renal, or hepatic effects associated with repeated topical ophthalmic application of 0.1% diclofenac to healthy cats. 8 healthy sexually intact male cats. A randomized, placebo-controlled crossover study was conducted. A topical formulation of 0.1% diclofenac was administered 4 times/d for 7 days to 4 cats, and artificial tear (control) solution was administered to the other 4 cats. After a 12-day washout period, cats received the other treatment. Ophthalmic examinations were performed daily. Plasma samples were obtained on days 1 and 7 for pharmacokinetic analysis. A CBC, serum biochemical analysis, urinalysis, determination of urine protein-to-creatinine ratio, and determination of glomerular filtration rate were performed before the start of the study and after each 7-day treatment period. Mild conjunctival hyperemia was the only adverse ocular effect detected. Maximal drug concentration and area under the curve were significantly higher on day 7 than on day 1. Diclofenac-treated cats had a significantly lower glomerular filtration rate than did control-treated cats after the second but not after the first treatment period, presumably associated with iatrogenic hypovolemia. Topical ophthalmic administration of 0.1% diclofenac was well tolerated in healthy cats, with only mild signs of ocular irritation. Detectable systemic concentrations of diclofenac were achieved with accumulation over 7 days. Systemic absorption of diclofenac may be associated with reduced glomerular filtration rate, particularly in volume-contracted animals. Topical ophthalmic 0.1% diclofenac should be used with caution in volume-contracted or systemically ill cats.

A Profile of Neuro-Ophthalmic Practice Around the World.

Science.gov (United States)

Frohman, Larry P

2018-03-01

To compare contrast neuro-ophthalmic practice in various countries, an 18-question survey was sent to the international North American Neuro-Ophthalmology Society (NANOS) members in the spring of 2016. At least 1 NANOS member was contacted for each non-US nation in the NANOS membership roster. If there were multiple NANOS members from 1 country, multiple were contacted. If responses were received from more than 1 person from a single country, the first response received was used as the source data. The survey (in English) was emailed to 47 NANOS members from 31 countries. Twenty responses were received representing members from 15 nations. In all 15 nations, at least half of the neuro-ophthalmologists were trained as ophthalmologists. In 60% of nations, at least half of the neuro-ophthalmologists were trained internally, whereas in 33% of countries, at least half were trained in the United States. The number of physicians who practiced a significant amount of neuro-ophthalmology ranged from low (0.08/million, India) to high (3.10/million, Israel). Countries having the highest percentage of neuro-ophthalmologists exclusively practicing neuro-ophthalmology also were those with better patient access to neuro-ophthalmic care. Requirement of approval to see a neuro-ophthalmologist or for imaging studies requested by neuro-ophthalmologists was not typical. In most nations, academic neuro-ophthalmologists were paid a straight salary. In no nation were neuro-ophthalmologists paid more than another ophthalmic subspecialty. Individual national health care system designs and compensation models have had a profound influence on the rewards and challenges that face neuro-ophthalmologists. There seems to have been a connection between recognition of the discipline, financial rewards of neuro-ophthalmic practice, conditions that permit full-time neuro-ophthalmic practice, and patient access to care. A higher percentage of gross national product for health care did not seem to

Fluid temperature at the corneal endothelium during phacoemulsification: comparison of an ophthalmic viscosurgical device and balanced salt solution using the finite element method.

Science.gov (United States)

Reepolmaha, Somporn; Limtrakarn, Wiroj; Uthaisang-Tanechpongtamb, Wanlaya; Dechaumphai, Pramote

2010-01-01

The purpose of this study was to estimate and compare the temperatures of two different anterior chamber solutions at the corneal endothelial level during phacoemulsification. An ophthalmic viscosurgical device (OVD) and balanced salt solution (BSS) were compared using the finite element method (FEM). The thermal properties of an OVD (IAL-F) and BSS were studied in an experimental setting. A computer-aided design model of ocular anatomy was created in two dimensions. The phaco needle was considered to be the only source of heat generation. Then, the FEM was used to demonstrate the transient temperature distribution in the two ocular models at 10, 20, 30, 40, 50 and 60 s. In these models, the anterior chamber was filled with IAL-F (IAL-F model) or BSS (BSS model). The heat generation rate of the phaco needle was 0.0004 cal/s/mm(2). The maximum corneal endothelial temperatures for the two models at 60 s were 52.67 and 41.57 degrees C, respectively. The experimental IAL-F model showed fewer changes in temperature for any given time and location. At larger distances from the heat source, less temperature variation was detected. Phacoemulsification is a potential heat-generating procedure performed between the delicate anterior chamber structures. During this procedure, IAL-F protects the endothelium against heat better than BSS. Copyright 2009 S. Karger AG, Basel.

IN-SITU OPHTHALMIC GELS FOR THE TREATMENT OF EYE DISEASES

OpenAIRE

M. Jothi, S.L. Harikumar* and Geeta Aggarwal

2012-01-01

Topical administration of a drug in the conjunctival cul-de-sac is the treatment of choice for diseases of the anterior segment of eye. Development of ophthalmic drug delivery systems has always been challenging because of the drawbacks with this route, like non-productive absorption, drainage, induced lacrimation, tear turn over, impermeability of drugs to cornea. New approaches have been investigated for delivery of drugs to the eye by means of polymeric delivery of ophthalmic drugs to the ...

Effect of dorzolamide/timolol combination on the visual field in glaucoma

Directory of Open Access Journals (Sweden)

Takeda S

2014-08-01

Full Text Available Sakurako Takeda,1,2 Tatsuya Mimura,1 Masao Matsubara1,2 1Department of Ophthalmology, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; 2Department of Ophthalmology, Nippori Clinic, Medical Center East, Tokyo Women’s Medical University, Tokyo, Japan Purpose: To evaluate the effect of treatment for 3 years with a dorzolamide/timolol (1%/0.5% fixed combination (DTFC on visual field progression in patients with open-angle glaucoma.Participants: A total of 14 consecutive patients were enrolled who had been previously treated with monotherapy or any combination of a beta blocker, carbonic anhydrase inhibitor, and/or prostaglandin analog for primary open-angle glaucoma (POAG; n=4 or normal-tension glaucoma (NTG; n=10.Methods: Patients were switched to DTFC from their prior glaucoma therapy. The IOP was measured at intervals of 4–6 weeks, and the visual fields were examined at least twice a year for 3 years. The annual change of mean deviation (MD slope was used to quantify visual field loss. Results: The mean MD value was –5.9±5.0 dB at baseline; it was –5.6±4.8 dB at 12 months, –5.9±5.0 dB at 24 months, and –5.6±5.1 dB at 36 months after switching. The mean MD slope was –0.2±0.8 dB/year before switching and 0.3±1.3 dB/year from baseline to 1 year, –0.3±1.1 dB/year from 1–2 years, and 0.3±0.9 dB/year from 2–3 years after switching. The mean MD slope from baseline to 36 months was correlated with the IOP reduction rate at 36 months after switching. Visual field progression was associated with the IOP reduction rate at 12 months after switching.Conclusion: Switching to DTFC from prior glaucoma therapy improved the MD slope for at least 3 years. Reduction of the IOP after switching to DTFC was effective for delaying visual field progression. Although our study was not nonrandomized and was small in scale, the findings suggest that DTFC might have a beneficial effect on the visual fields in patients with

Effect of 3 years of treatment with a dorzolamide/timolol (1%/0.5% combination on intraocular pressure

Directory of Open Access Journals (Sweden)

Takeda S

2014-09-01

Full Text Available Sakurako Takeda,1,2 Tatsuya Mimura,1 Masao Matsubara1,2 1Department of Ophthalmology, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; 2Department of Ophthalmology, Nippori Clinic, Medical Center East, Tokyo Women’s Medical University, Tokyo, Japan Purpose: We aimed to evaluate the effect on the intraocular pressure (IOP of a dorzolamide/timolol (1%/0.5% fixed combination (DTFC ophthalmic agent for 3 years.Participants: A total of 19 consecutive patients who had previously been treated with monotherapy or any combination of a beta-blocker, carbonic anhydrase inhibitor, or prostaglandin analog, for primary open-angle glaucoma (POAG (n=5 or normal tension glaucoma (N=14 were enrolled.Methods: Patients were switched to DTFC from their prior glaucoma therapy. The IOP was measured at intervals of 4–6 weeks for 3 years. Treatment failure was defined as an increase of IOP by ≥10% from baseline after switching to DTFC.Results: The average IOP decreased significantly from 14.1±2.9 mmHg at baseline to 12.2±2.2, 11.8±2.4, 12.1±2.5, 11.6±1.8, and 12.1±2.7 mmHg at 3, 6, 12, 24, and 36 months, respectively, after switching therapy (all P<0.05. The mean percent decrease of IOP was 12.0%±13.0%, 14.5%±14.2%, 12.2%±18.7%, 16.0%±12.8%, and 12.8%±15.2% at 3, 6, 12, 24, and 36 months, respectively, after switching. Univariate or multivariate analysis revealed the percent decrease of IOP was associated with the type of glaucoma (POAG at 3 and 12 months, and with the baseline IOP at 3, 12, 24, and 36 months. Kaplan–Meier analysis demonstrated that the percentage of patients who remained on treatment with DTFC was 94.7%, 94.7%, 84.2%, 78.9%, and 78.9% at 3, 6, 12, 24, and 36 months, respectively. Cox proportional hazards analysis showed that the type of glaucoma (POAG was associated with an increased risk of failure to control the IOP.Conclusion: The IOP-lowering effect of DTFC was demonstrated for 3 years in this

Subspecialization of the ophthalmic literature: a review of the publishing trends of the top general, clinical ophthalmic journals.

Science.gov (United States)

Kumar, Anupma; Cheeseman, Robert; Durnian, Jonathan M

2011-06-01

To investigate the publishing trends of the top general clinical ophthalmic journals and to report: (1) the proportions of articles published in terms of ophthalmic subspecialty, (2) the study design used, (3) any changes in publishing trends, and (4) any differences in the quality of study design between the subspecialties. Retrospective, database review. All original articles published in the top general, clinical ophthalmology journals from 2005 through 2009. All general, clinical ophthalmic journals were selected from the top 20 journals based on 2008 impact factor. All abstracts from original articles were reviewed, and the subject matter was recorded as belonging to 1 of the 11 ophthalmic subspecialties. After the content of the article was assigned, then the study design was recorded as one of the following: nonanalytic study, case-control or cohort study, randomized control trial, meta-analysis, laboratory science article, or systemic review. Subspecialty of the article and the study design used. Seven journals were included, and 12 426 abstracts were reviewed. Articles relating to medical retina were the most prevalent (29.1%), and those relating to strabismus were the least prevalent (2.3%). Case-control or cohort studies comprised most study designs (40.1%), with meta-analyses comprising the least (0.3%). The mean number of articles per year was 2485 (standard deviation, 125.1), remaining stable over the study period. Medical retina articles were significantly more common in 2009 than in 2005 (chi-square, 11.2; P = 0.0008), whereas the proportion of oculoplastic articles was significantly reduced (chi-square, 16.9; P<0.0001). Cataract and refractive surgery had the highest proportions of articles using the higher forms of study design (7.8%), and oculoplastics had the highest proportion of nonanalytic studies (64.5%). There are great differences across the specialty of ophthalmology in the subject matter of published literature, probably driven by recent

Ophthalmic Start-Up Chief Executive Officers' Perceptions of Development Hurdles.

Science.gov (United States)

Stewart, William C; Nelson, Lindsay A; Kruft, Bonnie; Stewart, Jeanette A

2018-01-01

To identify current challenges facing ophthalmic pharmaceutical start-ups in developing new products. Surveys were distributed to the chief executive officer (CEO) or president of ophthalmic start-ups. The survey attracted 24 responses from 78 surveys distributed (31%). The CEOs stated that a lack of financial capital (n = 18, 75%), FDA regulations (n = 6, 25%), and failure to meet clinical endpoints (n = 6, 25%) were their greatest development hurdles. Risk aversion to medicines in early development (n = 18, 75%), mergers and acquisitions reducing corporate choice for licensing agreements (n = 7, 29%), the emergence of large pharmaceutical-based venture capital funding groups (n = 12, 50%), and the failure of many large pharmaceutical companies to develop their own medicines (n = 10, 42%) were noted as recent prominent trends affecting fundraising. The study suggests that development funding, regulatory burden, and meeting clinical endpoints are the greatest development challenges faced by ophthalmic start-up CEOs. © 2017 S. Karger AG, Basel.

Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study.

Science.gov (United States)

García-López, Alfonso; Paczka, José A; Jiménez-Román, Jesús; Hartleben, Curt

2014-12-19

Fixed-combination ocular hypotensives have multiple advantages, but triple-therapy dorzolamide/brimonidine/timolol (dorz/brim/tim) is only available in Latin and South America, and information on its relative efficacy is limited. This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol (bim/tim) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension. In this investigator-masked, crossover study, patients with unmet target intraocular pressure (IOP) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3 months before returning to their pre-baseline medication for 3 months. IOP was evaluated before and after morning instillation at months 2, 3, 5 and 6. Primary endpoints were mean IOP change and Ocular Surface Disease Index© (OSDI) score at each visit. The intent-to-treat population was the a priori analysis population, but due to the number of discontinuations, the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses, respectively. Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations, respectively. At month 3, statistically significant IOP reductions from baseline were observed in the bim/tim (P < 0.01) and dorz/brim/tim (P < 0.0001) groups, regardless of assessment time. At month 6, patients returned to bim/tim exhibited no significant IOP increase (regardless of assessment time), but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase (P < 0.001) when assessed before instillation of study treatment. Results were similar in both intent-to-treat and per-protocol analysis populations. In the per-protocol analysis, 70% of patients on bim/tim at month 3 had an IOP <14 mm Hg, which declined to 58% (P = 0.0061) at month 6 (ie, after 3 months of dorz/brim/tim treatment). In patients receiving dorz/brim/tim at month 3

An international strategic plan to preserve and restore vision: four curricula of ophthalmic education.

Science.gov (United States)

Tso, Mark O M; Goldberg, Morton F; Lee, Andrew G; Selvarajah, Sivaguru; Parrish, Richard K; Zagorski, Zbigniew

2007-05-01

To highlight the four International Curricula of Ophthalmic Education developed by the Task Forces of the International Council of Ophthalmology, published in Klinische Monatsblätter für Augenheilkunde in November 2006. A global perspective of developing educational curricula as tools to improve eye care. Review of the experience and conclusions of the four international panels. The Task Force on Resident and Specialist Education developed a curriculum consisting of 15 topics in basic, standard, and advanced levels to provide flexibility of educational programs of the ophthalmic specialist in different locations across the world. The curricula were designed to be an educational tool to stimulate multiple levels of training of the ophthalmic specialist. The Task Force on Ophthalmic Education of Medical Students designed a curriculum covering 11 topics and provides illustrative materials for teachers and students. The Task Force strongly advocates the ophthalmology curriculum to be part of the core program of general medical schools education. The Task Force on Para-ophthalmic Vision Specialist Education developed a curriculum to highlight the importance of a team approach to eye care, consisting of ophthalmic specialists and paraophthalmic personnel to produce maximum efficiency. The Task Force on Continuing Medical Education (CME) designed a curriculum exploring the principles, elements, categories, and administration of CME activities in a variety of topics. These curricula shifted the traditional apprentice system of education to a curriculum-based training program in which goals, expectations, competencies, and technical training are defined to improve eye care worldwide.

21 CFR 349.14 - Ophthalmic emollients.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic emollients. 349.14 Section 349.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR.... (4) Petrolatum, up to 100 percent. (5) White ointment, up to 100 percent. (6) White petrolatum, up to...

Absorbed doses to the main parts of eyeball due to use 90Sr + 90Y ophthalmic applicator

International Nuclear Information System (INIS)

Chen Lishu

1993-05-01

The ophthalmic radiotherapy dosimetry and some affecting factors are introduced. The distributions of absorbed doses to the main parts of a fresh eyeball such as the cornea, sclera, lens and anterior chamber, during the radiotherapy by using a 90 Sr + 90 Y ophthalmic applicator are presented. An tissue-equivalent extrapolation ionization chamber was used in the dose measurement. The reasonable doses during ophthalmic radiotherapy for different depths have been obtained. Therefore, the absorbed dose to the lens, the most sensitive organ, can be given. These data are useful for radiation protection in ophthalmic radiotherapy

Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system

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Lovelace Cherie

2011-04-01

Full Text Available Abstract Background Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. Methods Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 105 and 106 colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. Results BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. Conclusions Latanoprost with 0

Effectiveness of ophthalmic solution preservatives: a comparison of latanoprost with 0.02% benzalkonium chloride and travoprost with the sofZia preservative system.

Science.gov (United States)

Ryan, Gerard; Fain, Joel M; Lovelace, Cherie; Gelotte, Karl M

2011-04-21

Although in vitro and in vivo laboratory studies have suggested that benzalkonium chloride (BAK) in topical ophthalmic solutions may be detrimental to corneal epithelial cells, multiple short- and long-term clinical studies have provided evidence supporting the safety of BAK. Despite the conflicting evidence, BAK is the most commonly used preservative in ophthalmic products largely due to its proven antimicrobial efficacy. This study was designed to characterize the antimicrobial performance of two commonly used topical ocular hypotensive agents that employ different preservative systems: latanoprost 0.005% with 0.02% BAK and travoprost 0.004% with sofZia, a proprietary ionic buffer system. Each product was tested for antimicrobial effectiveness by European Pharmacopoeia A (EP-A) standards, the most stringent standards of the three major compendia, which specify two early sampling time points (6 and 24 hours) not required by the United States Pharmacopeia or Japanese Pharmacopoeia. Aliquots were inoculated with between 10(5) and 10(6) colony-forming units of the test organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus brasiliensis. Sampling and enumeration were conducted at protocol-defined time points through 28 days. BAK-containing latanoprost met EP-A criteria by immediately reducing all bacterial challenge organisms to the test sensitivity and fungal challenges within the first six hours while the preservative activity of travoprost with sofZia did not. Complete bacterial reduction by travoprost with sofZia was not shown until seven days into the test, and fungal reduction never exceeded the requisite 2 logs during the 28-day test. Travoprost with sofZia also did not meet EP-B criteria due to its limited effectiveness against Staphylococcus aureus. Both products satisfied United States and Japanese pharmacopoeial criteria. Latanoprost with 0.02% BAK exhibited more effective microbial protection than

Dural AVM supplied by the ophthalmic artery.

LENUS (Irish Health Repository)

Flynn, T H

2012-02-03

Dural arteriovenous malformations in the anterior cranial fossa are rare and are especially prone to haemorrhage. These lesions are usually treated by surgical excision. We report the embolization of an anterior cranial fossa DAVM using an endovascular approach via the ophthalmic artery.

Superior ophthalmic vein enlargement and increased muscle index in dysthyroid optic neuropathy.

Science.gov (United States)

Lima, Breno da Rocha; Perry, Julian D

2013-01-01

To compare superior ophthalmic vein diameter and extraocular muscle index in patients with thyroid eye disease with or without optic neuropathy. High-resolution CT scan images of 40 orbits of 20 patients with history of thyroid eye disease (with or without optic neuropathy), who underwent orbital decompression surgery from January 2007 to November 2009, were retrospectively reviewed. Superior ophthalmic vein diameter was measured in coronal and axial planes. Extraocular muscle index was calculated according to the method proposed by Barrett et al. The clinical diagnosis of optic neuropathy was based on characteristic signs that included afferent pupillary defect, decreased visual acuity, visual field defects, and dyschromatopsia. Orbits were divided in 2 groups based on presence or absence of optic neuropathy. Superior ophthalmic vein diameter was significantly higher in orbits with concomitant optic neuropathy (mean 2.4 ± 0.4mm, p optic neuropathy (mean 57.9% ± 5.7%, p = 0.0002). Muscle index greater than 50% was present in all patients with dysthyroid optic neuropathy. This study suggests that patients with thyroid eye disease with enlarged superior ophthalmic vein and increased extraocular muscle index are more likely to have concomitant optic neuropathy.

Radioactivity measurements for some ophthalmic glasses

International Nuclear Information System (INIS)

Badawy, W.M.; Ali, E.M.; Gomaa, M.A.; Hussein, A

2007-01-01

The main aim of the present work is to implant the latest ICRP/IAEA recommendations related to exemption and clearness to the Ophthalmic Glass. As consumer product, glass lenses may contain trace quantities of uranium, thorium and potassium. Glass lenses under investigation were monitored for the detection of gamma rays and beta particles using radiation measuring devices. Using high purity germanium detector radioactivity concentration was estimated in Bq/kg. Activity concentration of 226 Ra, Th-232 and K-40 were determined using the energy gamma lines of 2l4 Pb (352 keV), 212 Pb (238 keV) and 1460 keV gamma line for 40 K respectively .Experimental results showed that radioactivity concentration for radium -226 varies from 0.19 to 4.98 Bq/kg of radium-226, from to 0.18 to 2.83 Bq/kg for thorium -232 and from 0.8 to 1.13 Bq/kg for potassium. Implementing new ICRP recommendation of exemption and clearness indicated that several Ophthalmic Glass should not be in use

Bepotastine besilate ophthalmic solution 1.5% for alleviating nasal symptoms in patients with allergic conjunctivitis

Directory of Open Access Journals (Sweden)

Cavet ME

2018-03-01

Full Text Available Megan E Cavet,1 Paul J Gomes,2 Warner W Carr,3 Jon I Williams4 1Bausch + Lomb, Rochester, NY, 2Ora, Andover, MA, 3Allergy and Asthma Associates of Southern California, Mission Viejo, CA, 4Bausch + Lomb, Irvine, CA, USA Background: Bepotastine besilate ophthalmic solution (BBOS 1.5% is a topical antihistamine for the treatment of ocular itching associated with allergic conjunctivitis (AC. Allergic rhinitis and AC are common comorbid conditions. We explored the efficacy of BBOS 1.5% in alleviating nasal symptoms in an integrated analysis of two Phase III conjunctival allergen challenge (CAC studies and a Phase IV environmental allergen study. Methods: In the Phase III trials, a CAC was performed 15 minutes, 8 hours, and 16 hours following ocular instillation of BBOS 1.5% (n=78 or placebo (n=79, and subjects evaluated nasal symptoms. In the environmental study, subjects instilled BBOS 1.5% (n=123 or placebo (n=122 twice daily and nasal symptoms were evaluated over 2 weeks. Results: In the Phase III trials, BBOS 1.5% had reduced CAC-induced nasal congestion and pruritus at 15 minutes and 8 hours postdosing and rhinorrhea and a non-ocular composite-symptom score (sum of nasal scores plus ear or palate pruritus at all time points postdosing (all P≤0.01 vs placebo. In the Phase IV environmental study, BBOS 1.5% reduced sneezing and nasal pruritus over 2 weeks and median number of days to improvement of nasal pruritus and total nasal symptom score (sum for rhinorrhea, sneezing, nasal pruritus, and nasal congestion; P≤0.04 vs placebo. Additionally, investigator-reported improvement in overall ocular (pruritus, hyperemia, tearing and nasal symptoms was greater with BBOS 1.5% vs placebo (P≤0.03. Conclusion: Results of these exploratory analyses indicate that topical ocular BBOS 1.5% reduced nasal symptoms, supporting its use for alleviating rhinitis symptoms associated with AC. Keywords: bepotastine besilate, nasal symptoms, allergic rhinitis

21 CFR 349.12 - Ophthalmic demulcents.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ophthalmic demulcents. 349.12 Section 349.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR....2 to 1 percent. (5) Propylene glycol, 0.2 to 1 percent. (e) Polyvinyl alcohol, 0.1 to 4 percent. (f...

Ophthalmic implications of seasonal affective disorder

International Nuclear Information System (INIS)

Paramore, J.E.; King, V.M.

1989-01-01

A review of seasonal affective disorder (SAD) is presented with a discussion of its standard treatment of phototherapy. A number of ophthalmic implications related to SAD are proposed. These implications relate to both the condition and the phototherapy used in its treatment, especially the use of full spectrum light which contains ultraviolet and near ultraviolet radiation. 12 references

[Tibolone's effect on retinal and ophthalmic arteries flowmetry].

Science.gov (United States)

Souza, Marco Aurélio Martins de; Geber, Selmo

2008-11-01

to evaluate the effect of tibolone use on doppler-velocimetric parameters of ophthalmic and retinal arteries. clinical, prospective, longitudinal, randomized, placebo-controlled, triple-blind study, in which among 100 menopausal women, 50 have used 2.5 mg of the active principle tibolone (Tib Group) and 50, placebo as a means to form the control-group (Plac Group). In the Tib Group, 44 of the 50 women returned after 84 days to finish the exams, and in the Plac Group, 47. The ophthalmic and retinal arteries were studied to determine the resistance index (RI), the pulsatility index (PI) and the systole/diastole ratio (S/D). Assessments have been done before and 84 days after medication. The t-Student test has been used for the comparison of means between the groups in independent samples, as well as for within-group comparisons in dependent samples. in both groups, the women's characteristics were similar in age, menopause duration, body mass index, arterial blood pressure, deliveries and cardiac rate. The Tib Group presented the following values in the ophthalmic artery: RI(pre)=0.71+/-0.05, RI(post)0.72+/-0.08 (p=0.43); PI(pre)=1.29+/-0.22, PI(post)=1.30+/-0.25 (p=0.4) and S/D(pre)=3.49+/-0.77, SD(post)=3.65+/-0.94 (p=0.32). In the retinal artery, the following values have been found: RI(pre)=0.67+/-0.09, RI(post)=0.69+/-0.10 (p=0.7); PI(pre)=1.20+/-0.29, PI(post)=1.22+/-0.3 (p=0.2) and SD(pre)=3.29+/-0.95, SD(post)=3.30+/-1.07 (p=0.3). Also, the tibolone and control groups did not show any significant difference in regard to the above indexes in the end of the study. the 2.5 mg dose of tibolone had no effect on the Doppler velocimetry indexes of the ophthalmic and retinal arteries.

Demonstration of efficacy in the treatment of dry eye disease with 0.18% sodium hyaluronate ophthalmic solution (vismed, rejena).

Science.gov (United States)

Vogel, Roger; Crockett, R Stephens; Oden, Neal; Laliberte, Terry W; Molina, Luis

2010-04-01

To evaluate the efficacy and safety of 0.18% sodium hyaluronate ophthalmic solution (Rejena, Vismed) compared with its vehicle for the treatment of signs and symptoms of dry eye disease. Randomized, placebo-controlled clinical trial. A total of 444 subjects with dry eye disease were randomized 1:1 to active study drug (n = 221) or vehicle control (n = 223) in this multicenter, double-masked trial. Subjects instilled 1 to 2 drops, 3 to 6 times daily for 14 days, with evaluations at Days 7 and 14. The study's 2 primary efficacy endpoints were change from baseline at Day 7 in lissamine green staining scores (objective) and in global symptom frequency scores (subjective). Results were analyzed using Wilcoxon rank sum test and Student t test in the intent-to-treat (ITT) population with last observation carried forward (LOCF). At Day 7, the differences between the active and vehicle groups in change from baseline for lissamine green staining score (P = .050, Wilcoxon; P = .029, t test) and global symptom frequency score (P = .050, Wilcoxon; P = .017, t test) were both statistically significant. There were no clinically relevant safety findings related to the use of Rejena. This study demonstrated the clinical efficacy of Rejena in the treatment of dry eye disease in both a primary objective endpoint and a primary subjective endpoint when compared to its vehicle. The study results also supported the well-known safety profile of Rejena. Copyright 2010 Elsevier Inc. All rights reserved.

[Biological availability of ophthalmic drugs. 1. Increasing drug permeability in the cornea].

Science.gov (United States)

Masteiková, R; Chalupová, Z; Savickiene, N

2004-03-01

Most eye diseases are treated by topical administration of ophthalmic preparations. Low ophthalmic bioavailability is due to a number of physiological and physicochemical factors. The main obstacle to the penetration of active ingredients to the eye is the layered character of the cornea. Formulation of ophthalmic preparations enabling easier penetration of this biological barrier thus ranks among the most effective ways of improving bioavailability. Penetrability of the cornea can be increased by the following methods: a) adjustment of the actual acidity in such a way that pH of the preparation makes it possible to produce the optimal portion of non-ionized particles; b) incorporation of absorption enhancers (non-ionic tensides, salts of bile acids, some antimicrobial substances, EDTA, cyclodextrins, etc.) into the composition of the preparation, and c) production of prodrugs or ionic pairs.

Fixed combination of bimatoprost and timolol in patients with primary open-angle glaucoma or ocular hypertension with inadequate IOP adjustment

Directory of Open Access Journals (Sweden)

Gerrett Brief

2010-09-01

Full Text Available Gerrett Brief1, Tobias Lammich2, Edgar Nagel3, Sabine Pfennigsdorf4, Christoph W Spraul5, Selwyn Ho61Facharzt für Augenheilkunde, Dortmund, Germany; 2Neubrandenburg, Germany; 3Augenarztpraxis Rudolstadt, Germany; 4Polch, Germany; 5Geiselhart, Ulm, Germany; 6Allergan Europe, Marlow, UKObjective: To assess the efficacy and tolerability of a fixed combination of bimatoprost and timolol (BTFC in a large patient sample in a clinical setting.Methods: In this multicenter, observational, noncontrolled, open-label study, patients (n = 1862 with primary open-angle glaucoma or ocular hypertension were treated with BTFC. Assessments were made at baseline, six weeks, and three months.Results: Prior to starting BTFC, 92.3% of patients were taking other ocular hypotensive medications. In the overall group at three months, mean intraocular pressure was reduced from baseline (21.7 ± 4.5 mmHg and 21.8 ± 4.9 mmHg for the right and left eye, respectively to 16.1 ± 3.0 mmHg for each eye (P < 0.0001. The majority of patients (92% reported no adverse events. The most commonly reported adverse events (in >1% of patients were eye irritation, and ocular and conjunctival hyperemia. Adherence to treatment was generally better than (35.4% or the same as (57.5% with prior therapy. BTFC tolerability was rated as excellent or good by 92.3% of physicians and 85.8% of patients.Conclusions: In a large group of patients with primary open-angle glaucoma or ocular hypertension, treatment with BTFC was associated with consistent reductions in IOP, improved adherence to treatment, and good tolerability.Keywords: bimatoprost, timolol, intraocular pressure, fixed combination, glaucoma

Access to the ophthalmic artery by retrograde approach through the posterior communicating artery for intra-arterial chemotherapy of retinoblastoma

Energy Technology Data Exchange (ETDEWEB)

Pham, Chi-Tuan; Blanc, Raphael; Pistocchi, Silvia; Bartolini, Bruno; Piotin, Michel [Fondation Rothschild Hospital, Department of Interventional Neuroradiology, Paris (France); Lumbroso-Le Rouic, Livia [Institut Curie, Department of Ocular Oncology, Paris (France)

2012-08-15

Intra-arterial infusion of chemotherapy into the ophthalmic artery for treatment of retinoblastoma has been realized after catheterization of the internal carotid and temporary balloon occlusion beyond the orifice of the ophthalmic artery, or more recently after superselective canulation of the ophthalmic artery by a microcatheter. The superselective catheterization of the ophthalmic artery could be cumbersome because of the implantation of the ostium on the carotid siphon or because of the tortuosity of the carotid siphon. We report our experience of using a retrograde approach through the posterior communicating artery that allows a more direct angle of access to the origin of the ophthalmic artery. (orig.)

Are we pharmacovigilant enough in ophthalmic practice?

Directory of Open Access Journals (Sweden)

Ashok Dubey

2013-01-01

Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

Ophthalmic plastic and orbital surgery in Taiwan.

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Hsu, Chi-Hsin; Lin, I-Chan; Shen, Yun-Dun; Hsu, Wen-Ming

2014-06-01

We describe in this paper the current status of ophthalmic plastic and orbital surgery in Taiwan. Data were collected from the Bureau of National Health Insurance of Taiwan, the Bulletin of the Taiwan Ophthalmic Plastic and Reconstructive Society, and the Statistics Yearbook of Practicing Physicians and Health Care Organizations in Taiwan by the Taiwan Medical Association. We ascertained that 94 ophthalmologists were oculoplastic surgeons and accounted for 5.8% of 1621 ophthalmologists in Taiwan. They had their fellowship training abroad (most ophthalmologists trained in the United States of America) or in Taiwan. All ophthalmologists were well trained and capable of performing major oculoplastic surgeries. The payment rates by our National Health Insurance for oculoplastic and orbital surgeries are relatively low, compared to Medicare payments in the United States. Ophthalmologists should promote the concept that oculoplastic surgeons specialize in periorbital plastic and aesthetic surgeries. However, general ophthalmologists should receive more educational courses on oculoplastic and cosmetic surgery. Copyright © 2014. Published by Elsevier B.V.

Ophthalmic examination in early diagnosis of Alzheimer's disease

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Xin Li

2018-02-01

Full Text Available Alzheimer's disease is a progressive neurodegenerative disorder causing irreversible deterioration in memory and loss of self-care ability, which is seriously affecting the quality of life. There is no cure for Alzheimer's disease. Medication only can control the progression of the disease. Early diagnosis and control of disease progress is of great significance in improving the quality of life of the patients and reducing the burden of family and society. Ophthalmic examination is seen as a window which can “see” brain directly, and some changes in the eye can reflect the changes of the brain most directly. This paper reviews the ophthalmic examination of Alzheimer's disease, including optical coherence tomography(OCT, visual field, contrast sensitivity and eye movements, et al. We hope to provide a new idea for the early diagnosis of Alzheimer's disease.

Postoperative pain in complex ophthalmic surgical procedures: comparing practice with guidelines.

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Lesin, Mladen; Sundov, Zeljka Duplancic; Jukic, Marko; Puljak, Livia

2014-06-01

To analyze the management of postoperative pain after complex ophthalmic surgery and to compare it to the guidelines. A retrospective study. University Hospital Split, Croatia. Patients (N = 447) who underwent complex ophthalmic surgical procedures from 2008 to 2012. The following data were extracted from patient medical records: age, gender, type and dosage of premedication, preoperative patient's physical status, type of procedure, duration of procedure-surgical and anesthesia time, type and dosage of anesthesia, the type and dosage of postoperative analgesia for each postoperative day. None of the patients had information about pain intensity in their records. There were 90% patients who did not receive any medication the night before surgery, 54% did not receive any premedication immediately before surgery, 19% did not receive any pain medication after the surgery in the operating room and 46% of patients did not receive any analgesics after being released to the ophthalmology department. Among those who received analgesia after surgery, 98% received only one dose of an analgesic, and 93% of patients received analgesia only on the day of the surgery. Furthermore, patients were returned to the department immediately after surgery, without intensive monitoring. During the analyzed five years there were no educational session organized by anesthesiologist to the ophthalmic surgeons. Postoperative pain management and perioperative care of patients undergoing major ophthalmic surgery indicates lack of attention towards pain intensity and postoperative analgesia. Appropriate interventions should be employed to improve postoperative pain management, to facilitate patient recovery. Wiley Periodicals, Inc.

Ocular penetration and pharmacokinetics of topical gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions after keratoplasty.

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Holland, Edward J; Lane, Stephen S; Kim, Terry; Raizman, Michael; Dunn, Steven

2008-04-01

To compare the corneal and aqueous penetration and pharmacokinetics of gatifloxacin 0.3% and moxifloxacin 0.5% ophthalmic solutions and their effect on corneal reepithelialization after penetrating keratoplasty. In this randomized, open-label, parallel-controlled study, corneal and aqueous penetration and the pharmacokinetic parameters of topically applied gatifloxacin 0.3% and moxifloxacin 0.5% (2 preoperative doses of 1 drop given 5 minutes apart) were estimated by using a sparse sampling method. Corneal and aqueous samples were collected 0.25, 0.5, 1, or 2 hours after the final dose. The concentration was determined by a high-performance liquid chromatography method. Stromal Cmax:MBC50 (maximum drug concentration in serum to 50% minimum bactericidal concentration) ratios for selected ocular pathogens were also assessed. Postoperative corneal reepithelialization at days 1, 3, and 7 was evaluated and compared between groups. The calculated pharmacokinetic parameters were higher with moxifloxacin 0.5% than with gatifloxacin 0.3%. The stromal Cmax was 48.5 versus 15.7 microg/g (P = 0.04), and the stromal AUC0-2 (area under the concentration-time curve from 0 to 2 hours) was 30.9 versus 13.6 mug.h/g (P 0.05), and the endothelial AUC0-2 was 43.9 versus 9.8 microg.h/g (P 0.05), and the aqueous AUC0-2 was 1.2 versus 0.4 microg.h/mL (P < 0.05). Stromal Cmax:MBC50 ratios were higher in the moxifloxacin 0.5% group for each pathogen tested. The corneal reepithelialization rates were comparable between groups. Topical preoperative moxifloxacin 0.5% achieved greater corneal and aqueous penetration than did gatifloxacin 0.3%. The clinical significance of this difference is not known. Postoperative use of these agents had similar effects on corneal reepithelialization.

Validation of a stability-indicating spectrometric method for the determination of sulfacetamide sodium in pure form and ophthalmic preparations

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Sofia Ahmed

2017-01-01

Full Text Available Introduction: Sulfacetamide sodium is a widely used sulfonamide for ophthalmic infections. Objective: A number of analytical methods have been reported for the analysis of sulfacetamide but they lack the ability to determine both the active drug and its major degradation product, sulfanilamide, simultaneously in a sample. Materials and Methods: In the present study a simple, rapid and economical stability-indicating UV spectrometric method has been validated for the simultaneous assay of sulfacetamide sodium and sulfanilamide in pure form and in ophthalmic preparations. Results: The method has been found to be accurate (recovery 100.03 ±0.589% and precise (RSD 0.587% with detectable and quantifiable limits of 1.67×10–6 M (0.04 mg% and 5.07×10–6 M (0.13 mg%, respectively for the assay of pure sulfacetamide sodium. The method is also found to be accurate and precise to small changes in wavelength, pH and buffer concentration as well as to forced degradation. The study further includes the validation of the method for the assay of pure sulfanilamide in solution, which has been found to be accurate, precise and robust. Conclusion: The results indicate that the proposed two-component spectrometric method is stability-indicating and can be used for the simultaneous assay of both sulfacetamide sodium and sulfanilamide in synthetic mixtures and degraded solutions.

Audit of patients' awareness of ophthalmic diagnoses.

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Sudesh, S; Downes, S M; McDonnell, P J

1993-09-01

Providing information to patients about their medical condition and treatment options is important in medical management. To assess patients' knowledge of their ocular disease, prognosis, and treatment a questionnaire based survey was performed. 219 patients selected by random systematic sampling during six months from patients attending general ophthalmic clinics in Selly Oak Hospital, Birmingham, were questioned and 217 questionnaires were analysed. The findings showed that patients' knowledge of their diagnosis depended on their condition: patients with common conditions such as glaucoma and cataract had a better understanding of their condition, its treatment, and prognosis compared with patients with rarer conditions such as retinal detachment or patients with multiple diagnoses. In all, 152 patients (70%) wanted more information about their condition; 49 (23%) did not (although 12 (25%) had attempted to obtain information); and 16 (7%) were undecided. In view of the few patients with a precise understanding of their ophthalmic diagnosis and prognosis and the majority's wish for access to further information, that access needs improvement and different modes of disseminating the information should be implemented.

Pulsed UV laser technologies for ophthalmic surgery

International Nuclear Information System (INIS)

Razhev, A M; Bagayev, S N; Churkin, D S; Kargapol’tsev, E S; Chernykh, V V; Iskakov, I A; Ermakova, O V

2017-01-01

The paper provides an overview of the results of multiyear joint researches of team of collaborators of Institute of Laser Physics SB RAS together with NF IRTC “Eye Microsurgery” for the period from 1988 to the present, in which were first proposed and experimentally realized laser medical technologies for correction of refractive errors of known today as LASIK, the treatment of ophthalmic herpes and open-angle glaucoma. It is proposed to carry out operations for the correction of refractive errors the use of UV excimer KrCl laser with a wavelength of 222 nm. The same laser emission is the most suitable for the treatment of ophthalmic herpes, because it has a high clinical effect, combined with many years of absence of recrudescence. A minimally invasive technique of glaucoma operations using excimer XeCl laser (λ=308 nm) is developed. Its wavelength allows perform all stages of glaucoma operations, while the laser head itself has high stability and lifetime, will significantly reduce operating costs, compared with other types of lasers. (paper)

Pediatric ophthalmic indications for examination under anesthesia in ...

African Journals Online (AJOL)

Objective: To determine the ophthalmic indications and challenges for pediatric ocular examination under anesthesia (EUA). Methods: The surgical register and patients' records of children who underwent EUA between 1990 and 2007 were examined to document patients' bio data, diagnoses and details of procedures and ...

A new human eye model for ophthalmic brachytherapy dosimetry

International Nuclear Information System (INIS)

Yoriyaz, H.; Sanchez, A.; Dos Santos, A.

2005-01-01

The present work proposes a new mathematical eye model for ophthalmic brachytherapy dosimetry. This new model includes detailed description of internal structures that were not treated in previous works, allowing dose determination in different regions of the eye for a more adequate clinical analysis. Dose calculations were determined with the MCNP-4C Monte Carlo particle transport code running n parallel environment using PVM. The Amersham CKA4 ophthalmic applicator has been chosen and the depth dose distribution has been determined and compared to those provide by the manufacturer. The results have shown excellent agreement. Besides, absorbed dose values due to both 125 I seeds and 60 Co plaques were obtained for each one of the different structures which compose the eye model and can give relevant information in eventual clinical analyses. (authors)

[Antimicrobial Effects of Iodine-Polyvinyl Alcohol Ophthalmic and Eye Washing Solution (PA * IODO) with Special Reference to its Temperature, Concentration and Time and its Preservation Stability].

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Hatano, Hiroshi; Sakamoto, Masako; Hayashi, Kazuo; Kamiya, Seigo

2015-08-01

Temperature, concentration and time are the three factors that affect the inactivation capacity of iodine antiseptics. We investigated the effect of these factors on the microbe inactivation of Iodine-Polyvinyl Alcohol ophthalmic and eye washing solution (PA * IODO), and also investigated the preservation conditions on stability of the inactivation activity of the PA * IODO. Test microbes were mixed with PA * IODO, varying the three factors. The live microbes were counted after each reaction. The effects of plugging and preservation temperature were investigated to determine the preserving stability. The inactivation capacity of PA * IODO tended to decrease in almost all microbes tested at 4 degrees C. Twenty times or less diluted PA * IODO killed almost all microbes completely. The time effect was more marked in viruses. Plugging and low-temperature made iodine concentration in diluted PA * IODO remain relatively high. The concentration of PA * IODO affected the inactivation ability more than the temperature and time, although all the three factors correlated positively to the inactivation. For preservation the diluted PA * IODO needed plugging and low temperature.

Financial return-on-investment of ophthalmic interventions: a new paradigm.

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Brown, Melissa M; Brown, Gary C; Lieske, Heidi B; Lieske, P Alexander

2014-05-01

Although the patient value gain (improvement in quality-of-life and/or length-of-life) has been highlighted in Value-based Medicine cost-utility analyses, the financial value gain associated with healthcare interventions has received less emphasis. It is important for professional healthcare providers to realize their interventions often confer a large financial return-on-investment (ROI) to society. The societal costs associated with vitreoretinal and other ophthalmic interventions include: direct ophthalmic medical costs expended (hospital, physician, drug, diagnostic testing and so forth), direct medical costs saved (decreased costs for depression, injury, skilled nursing facility, nursing home and others), direct nonmedical costs saved (decreased costs for caregivers, transportation, residence costs, moving costs, and others), and indirect medical costs saved (improving employment incidence and wages). The financial ROI for direct ophthalmic medical costs expended for ranibizumab therapy for neovascular age-related macular degeneration is 450%, whereas that for cataract surgery is 4500% and for medical open-angle glaucoma therapy is 4000%. Many costs gained add to the Gross Domestic Product and increase the wealth of the nation. Many vitreoretinal and other ophthalmologic interventions confer considerable patient value, but also result in a large financial ROI to society. This financial ROI increases the wealth of the nation.

Comparative studies of HPLC-fluorometry and LC/MS method for the determination of N-acetylneuraminic acid as a marker of deteriorated ophthalmic solutions.

Science.gov (United States)

Iwatsuka, Kinya; Yasueda, Shin-ichi; Bando, Eiji; Fujii, Hiroyuki; Terada, Takashi; Okubo, Hiroya; Iwamoto, Hiroki; Kinoshita, Mitsuhiro; Kakehi, Kazuaki

2011-10-01

Methods for determining the deterioration of ophthalmic solutions using both high-performance liquid chromatography (HPLC) with fluorescence detection and liquid chromatography coupled with selected ion monitoring mass spectrometry (LC/MS) are described. The methods are based on the determination of N-acetylneuraminic acid (NeuAc) released by the hydrolysis of foreign bodies that contaminate eye drops during use. The released NeuAc was either labeled with 1,2-diamino-4,5-methylenedioxybenzene (DMB) for fluorometric detection or detected without derivatization by mass spectrometry. The calibration curves for NeuAc showed good linearity between 1.2 ng/mL and 39 ng/mL for fluorometric HPLC and 5.0 ng/mL and 100 ng/mL for LC/MS, respectively. Detection limits for fluorometric HPLC and LC/MS were 0.20 ng/mL and 0.88 ng/mL, respectively. The NeuAc content of some model glycoproteins determined by LC/MS method were 62-78% of those determined by fluorometry. The differences are attributed to matrix effects but the LC/MS method afforded sufficiently high sensitivity that NeuAc in the foreign bodies could be determined in eight of nine test samples. Copyright © 2011 Elsevier B.V. All rights reserved.

A new method for characterizing beta-ray ophthalmic applicator sources

International Nuclear Information System (INIS)

Sayeg, J.A.; Gregory, R.C.

1991-01-01

A technique is described which enables one to obtain detailed dose characteristics of 90Sr beta-ray ophthalmic applicators. A radiochromic radiation detector which is a solid-state solution of hexahydroxyethyl pararosaniline cyanide in a nylon polymer (i.e., thin foil), has been used to determine the surface dose rate and dose distribution of these sources. The detectors are rugged, easily handled, have an equivalent response (optical density per unit absorbed dose) to photons and electrons, and produce high-resolution images. They have been found useful for this application due to the high surface dose rates [0.10-1.0 Gy (H2O)/s] and their low sensitivity (approximately 10(4) Gy for an optical density of 1.0). The foils have been evaluated on a He-Ne scanning laser densitometer with a resolution of 0.3 mum. Comparison with NIST (formerly NBS) extrapolation ionization chamber measurements indicates surface dose-rate agreement within 6%. Spectral dosimetric characteristics are presented and discussed

21 CFR 524.390a - Chloramphenicol ophthalmic ointment.

Science.gov (United States)

2010-04-01

... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS... treatment for 48 hours (2 days) after eye appears normal. Therapy for cats should not exceed 7 days... therapy should be considered. When infection may be cause of disease, especially in purulent or catarrhal...

Doppler sonographic evaluation of ophthalmic arterial flow pattern in hypertensive patients

International Nuclear Information System (INIS)

Ryu, Dae Sik; Kim, Young Goo

1994-01-01

To compare the Doppler velocity waveform pattern of ophthalmic artery of hypertensive patients with that of normotensive subjects. Doppler velocity waveform was obtained from ophthalmic artery in 45 hypertensive patients and 60 normotensive subjects. Both hypertensives and normotensive subjects were classified according to age into those younger than and those older than 45 years. Doppler indices(pulsatility index(PI), resistance index(RI), the first systolic peak/the second systolic peak(S1/S2), the first systolic peak/diastolic peak(S1/D)) measured in hypertensive patients were compared with normotensive subjects. Among the various doppler indices, only S1/S2 showed significant difference(P < 0.05) between the hypertensive patients and normotensive subjects younger than 45 years. Doppler velocity waveform of hypertensive patients older than 45 years showed no significant difference from that of normotensive subjects with corresponding age. Doppler velocity waveform of ophthalmic artery in hypertensive patients younger than 45 years shows pattern with S2 higher than that of normotensive subjects. High S2 component(reflective-wave) may represent increased vascular impedance due to vasococonstriction of retinal arterioles in hypertensive patients

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

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Jenke, Dennis; Egert, Thomas; Hendricker, Alan; Castner, James; Feinberg, Tom; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank; Markovic, Ingrid

2017-01-01

A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products. This container-closure system consisted of a linear low-density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling), and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1 v/v isopropanol/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch, and the filled and pouched units were stored either upright or inverted for up to 6 months at 40 °C. After storage, the leaching solutions were tested for leached substances using multiple complementary analytical techniques to address volatile, semi-volatile, and non-volatile organic and inorganic extractables as potential leachables.The leaching data generated supported several conclusions, including that (1) the extractables (leachables) profile revealed by a simulating leaching study can qualitatively be correlated with compositional information for materials of construction, (2) the chemical nature of both the extracting medium and the individual extractables (leachables) can markedly affect the resulting profile, and (3) while direct contact between a drug product and a system's material of construction may exacerbate the leaching of substances from that material by the drug product, direct contact is not a prerequisite for migration and leaching to occur. LAY ABSTRACT: The migration of container-related extractables from a model pharmaceutical container-closure system and into simulated drug product solutions was studied, focusing on circumstances relevant to parenteral and ophthalmic drug products. The model system was constructed specifically to address the migration of extractables from labels applied to the outside of the

New Zealand health reforms: effect on ophthalmic practice.

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Raynel, S; Reynolds, H

1999-01-01

Are specialized ophthalmic units with inpatient facilities going to disappear in the New Zealand public health system? We have entered the era of cost containment, business methodologies, bench marking, day case surgery, and technologic advances. The dilemma for nursing is maintenance of a skill base with dwindling clinical practice areas.

Stability-Indicating HPTLC Method for Simultaneous Estimation of Flurbiprofen and Chloramphenicol in Ophthalmic Solution.

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Sadakwala, Vaishnavi M; Chauhan, Renu S; Shah, Shailesh A; Shah, Dinesh R

2016-01-01

A specific, accurate and reproducible stability-indicating high performance thin layer chromatography (HPTLC) method was developed for the estimation of flurbiprofen and chloramphenicol in the presence of their degradation products. Degradation studies of both the drugs were carried out in acidic, alkaline, neutral, oxidative, photolytic and thermal stress conditions. Separation was performed on thin layer chromatography plate precoated with silica gel 60 F254 using ethyl acetate : n-hexane : methanol : tri-ethyl amine (5 : 4 : 2 : 0.5, v/v/v/v). Spots at retention factor 0.29 and 0.62 were recognized as flurbiprofen and chloramphenicol, respectively, and were quantified through densitometric measurements at wavelength 267 nm. Method was found to be linear over the concentration range 12-60 ng/spot with correlation coefficient of 0.9997 for flurbiprofen and 200-1,000 ng/spot with correlation coefficient of 0.9977 for chloramphenicol. The proposed method was applied to the estimation of flurbiprofen and chloramphenicol in commercial ophthalmic formulation. The developed HPTLC method can be applied for routine analysis of flurbiprofen and chloramphenicol in the presence of their degradation products in their individual as well as combined pharmaceutical formulations. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Preoperative Hand Decontamination in Ophthalmic Surgery: A Comparison of the Removal of Bacteria from Surgeons' Hands by Routine Antimicrobial Scrub versus an Alcoholic Hand Rub.

Science.gov (United States)

Forer, Yaara; Block, Colin; Frenkel, Shahar

2017-09-01

The goal of this experiment was to evaluate and compare the antimicrobial efficacy of routine preoperative hand washing using commercial medicated sponge brushes versus an alcoholic hand rub, by comparing bacterial growth on ophthalmic surgeons' hands after application of each of these methods. Twenty ophthalmic surgeons were recruited at the Hadassah-Hebrew University Medical Center in Jerusalem, Israel. Samples were collected twice from the hands of each surgeon after hand decontamination using two different protocols during routine surgical practice. The routine preparation consisted of a 3-minute surgical scrub using commercial brush-sponges incorporating either 4% chlorhexidine gluconate (CHG) or 1% povidone-iodine (PVP-I) formulations with detergent, followed by drying the hands with a sterile towel, while the 70% ethanol solution was applied for 60-seconds and allowed to air dry. Half of the group was randomly assigned to provide samples first after the routine method and the alcoholic solution a week later, and the other half of the group was sampled in the reverse order. Viable counts of bacteria were evaluated using a modified glove juice method. Bacterial colonies were enumerated after incubation for 24 hours and expressed as colony forming units (CFU)/mL for each pair of hands. Geometric mean counts were 1310 and 39 CFU/mL, in the routine and alcohol rub groups, respectively, representing a mean log 10 reduction in 1.53. The difference between the paired bacterial counts for the routine versus the alcohol rub was statistically significant (p surgical hand preparation with PVP-I and CHG in a population of practicing ophthalmic surgeons in the operative clinical setting. Thus, it provides a safe alternative as a preoperative hand disinfection method.

Ophthalmic Morbidity in School Children in Hilly Areas of Uttarakhand

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Surekha Kishore

2014-03-01

Full Text Available Introduction: School children constitute about one fourth of population of India. Early detection and treatment of various eye diseases helps in avoiding many complications. The magnitude of blindness is 3-4 times greater in developing countries. Very few studies have been conducted in Uttarakhand revealing the ophthalmic morbidity in school children or general population. Hilly areas especially the remote ones face various problems like, poor transportation facilities, distant health facilities, use of traditional methods for treatment, faith healing, customs and belief system, lack of information.  Moreover   water supply, poor personal hygiene and other factors also add up to these problems. Aim: To study the ophthalmic morbidities in school children in 3 schools of Thatyur block. Methodology: It was a cross sectional study. Result: A total of 705 students were enrolled. Permission from school authorities was seeked before the start of study. Schools were visited twice in a week current and preliminary information was taken from the students & teacher regarding education, occupation, income etc. General examination and ophthalmic examination was done with day & torch light along with refraction, with the help of standard Snellen’s chart. Each eye was examined separately. A vision of 6/6 was considered as normal. Near vision was tested with new vision Snellen’s chart at 12-14 inches away from eye.

Ophthalmic Morbidity in School Children in Hilly Areas of Uttarakhand

Directory of Open Access Journals (Sweden)

Surekha Kishore

2014-03-01

Full Text Available Introduction: School children constitute about one fourth of population of India. Early detection and treatment of various eye diseases helps in avoiding many complications. The magnitude of blindness is 3-4 times greater in developing countries. Very few studies have been conducted in Uttarakhand revealing the ophthalmic morbidity in school children or general population. Hilly areas especially the remote ones face various problems like, poor transportation facilities, distant health facilities, use of traditional methods for treatment, faith healing, customs and belief system, lack of information.  Moreover   water supply, poor personal hygiene and other factors also add up to these problems. Aim: To study the ophthalmic morbidities in school children in 3 schools of Thatyur block. Methodology: It was a cross sectional study. Result: A total of 705 students were enrolled. Permission from school authorities was seeked before the start of study. Schools were visited twice in a week current and preliminary information was taken from the students & teacher regarding education, occupation, income etc. General examination and ophthalmic examination was done with day & torch light along with refraction, with the help of standard Snellen’s chart. Each eye was examined separately. A vision of 6/6 was considered as normal. Near vision was tested with new vision Snellen’s chart at 12-14 inches away from eye.

Re-evaluation of Magnetic Resonance and Computerised Tomographic Imaging in Neuro-Ophthalmic Patients in an Academic Centre

NARCIS (Netherlands)

Koekoek, Clarence G. J.; Meiners, Linda C.; Pott, Jan Willem R.

The aim of the study is to report the frequency of missed diagnoses on magnetic resonance and computerised tomographic imaging in neuro-ophthalmic patients who were referred to an academic ophthalmology department, with apparent normal imaging. The authors included all neuro-ophthalmic patients,

Oxidative-stress detoxification and signalling in cyanobacteria: the crucial glutathione synthesis pathway supports the production of ergothioneine and ophthalmate.

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Narainsamy, Kinsley; Farci, Sandrine; Braun, Emilie; Junot, Christophe; Cassier-Chauvat, Corinne; Chauvat, Franck

2016-04-01

Using genetics and metabolomics we investigated the synthesis (gshA and gshB genes) and catabolism (ggt) of the conserved antioxidant glutathione in the model cyanobacterium Synechocystis PCC6803. These three genes are crucial to Synechocystis, in agreement with the proposed invention of glutathione by ancient cyanobacteria to protect themselves against the toxicity of oxygen they produced through photosynthesis. Consistent with their indispensability, gshA and gshB also operate in the production of another antioxidant, ergothioneine, as well as of the glutathione analogues ophthalmate and norophthalmate. Furthermore, we show that glutathione, ophthalmate and norophthalmate are accumulated in cells stressed by glucose, and that the two glutathione-dependent glyoxalase enzymes operate in the protection against glucose and its catabolite methylglyoxal. These findings are interesting because ophthalmate and norophthalmate were observed only in mammals so far, where ophthalmate is regarded as a biomarker of glutathione depletion. Instead, our data suggest that ophthalmate and norophthalmate are stress-induced markers of cysteine depletion triggered by its accelerated incorporation into glutathione, to face its increased demand for detoxification purposes. Hence, Synechocystis is an attractive model for the analysis of the role of glutathione, ergothioneine, ophthalmate and norophthalmate, in signalling and detoxification of oxidants and metabolic by-products. © 2015 John Wiley & Sons Ltd.

Ophthalmic manifestations of head injury.

Science.gov (United States)

Kowal, L

1992-02-01

Head injuries are frequently associated with ophthalmic problems. The commonest problems seen in this series of 161 patients with head injury were problems with poor accommodation (16% of patients; 58% of these persisted), convergence (14% of patients; 35% of these persisted), pseudomyopia (19%; 55% persisted) and optic atrophy (26% of the patients; 78% of these were mild and easily missed on routine testing, and 22% were severe). Motility disorders were common, especially cranial nerve palsies. Other less frequent motility disturbances included apparent inferior oblique palsy, comitant esotropia, and exotropia which was often of the convergence insufficiency type.

Additive intraocular pressure-lowering effect of dorzolamide 1%/timolol 0.5% fixed combination on prostaglandin monotherapy in patients with normal tension glaucoma

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Mizoguchi T

2011-10-01

Full Text Available Takanori Mizoguchi1, Mineo Ozaki2, Harumi Wakiyama1,3, Nobuchika Ogino11Mizoguchi Eye Clinic, Sasebo, 2Ozaki Eye Clinic and Dept of Opthalmology, Faculty of Medicine, University of Miyazaki, Miyazaki, 3The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, JapanPurpose: To evaluate the intraocular pressure (IOP-lowering effect of adding dorzolamide 1.0%/timolol 0.5% fixed combination (DTFC to prostaglandin analogs (PGAs as monotherapy in patients with normal tension glaucoma.Methods: A prospective, clinical, case-controlled study of patients with normal tension glaucoma. Patients had been on a once-daily night dose of prostaglandins (PGs as monotherapy and then received DTFC added to PGs for 8 weeks. The IOP was measured at 9 am, week 0 (baseline, week 4, and week 8.Results: The baseline IOP of 40 patients who had previously been treated by prostaglandin monotherapy was 15.6 ± 2.0 mmHg at baseline. The IOPs at 4 and 8 weeks after adding DTFC to PGs were 13.5 ± 2.1 mmHg and 13.7 ± 2.2 mmHg, respectively. Significant decrease of the IOP was observed at each time point of measurement as compared with the baseline IOP before adding DTFC (P = 0.01. The percent IOP reduction from the baseline IOP at week 4 and week 8 was 13.5% ± 12.3% and 11.7% ± 13.1%, respectively. The percentage of patients who achieved 10% or more IOP reduction from the baseline IOP at week 8 was 62.5%. The baseline IOP was significantly correlated with the percent IOP reduction at week 8 (P = 0.03, r = 0.34.Conclusion: DTFC therapy added to PGAs as glaucoma monotherapy is effective in patients with normal tension glaucoma.Keywords: IOP-lowering effect, prostaglandin, dorzolamide 1%/timolol 0.5% fixed combination, fixed combination, normal tension glaucoma

Outpatients flow management and ophthalmic electronic medical records system in university hospital using Yahgee Document View.

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Matsuo, Toshihiko; Gochi, Akira; Hirakawa, Tsuyoshi; Ito, Tadashi; Kohno, Yoshihisa

2010-10-01

General electronic medical records systems remain insufficient for ophthalmology outpatient clinics from the viewpoint of dealing with many ophthalmic examinations and images in a large number of patients. Filing systems for documents and images by Yahgee Document View (Yahgee, Inc.) were introduced on the platform of general electronic medical records system (Fujitsu, Inc.). Outpatients flow management system and electronic medical records system for ophthalmology were constructed. All images from ophthalmic appliances were transported to Yahgee Image by the MaxFile gateway system (P4 Medic, Inc.). The flow of outpatients going through examinations such as visual acuity testing were monitored by the list "Ophthalmology Outpatients List" by Yahgee Workflow in addition to the list "Patients Reception List" by Fujitsu. Patients' identification number was scanned with bar code readers attached to ophthalmic appliances. Dual monitors were placed in doctors' rooms to show Fujitsu Medical Records on the left-hand monitor and ophthalmic charts of Yahgee Document on the right-hand monitor. The data of manually-inputted visual acuity, automatically-exported autorefractometry and non-contact tonometry on a new template, MaxFile ED, were again automatically transported to designated boxes on ophthalmic charts of Yahgee Document. Images such as fundus photographs, fluorescein angiograms, optical coherence tomographic and ultrasound scans were viewed by Yahgee Image, and were copy-and-pasted to assigned boxes on the ophthalmic charts. Ordering such as appointments, drug prescription, fees and diagnoses input, central laboratory tests, surgical theater and ward room reservations were placed by functions of the Fujitsu electronic medical records system. The combination of the Fujitsu electronic medical records and Yahgee Document View systems enabled the University Hospital to examine the same number of outpatients as prior to the implementation of the computerized filing system.

21 CFR 524.1484a - Neomycin sulfate ophthalmic ointment.

Science.gov (United States)

2010-04-01

... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS...) Severe infections should be supplemented by systemic therapy. (5) Prolonged administration of the drug... bacteria or fungi appear during therapy, appropriate measures should be taken. (6) Federal law restricts...

Longitudinal ophthalmic findings in a child with Helsmoortel-Van der Aa Syndrome

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Michael J. Gale

2018-06-01

Full Text Available Purpose: We present the first detailed ophthalmic description of a child with Helsmoortel-Van der Aa Syndrome (HVDAS, including longitudinal follow-up and analysis. Observations: After extensive workup, a young child with poor visual behavior, hypotonic cerebral palsy, intellectual disability, and global developmental delay was found to have a heterozygous de novo mutation in the ADNP gene and diagnosed with HVDAS. Ophthalmic findings were remarkable for progressive nystagmus, macular pigment mottling, mild foveal hypoplasia with abnormal macular laminations, persistent rod dysfunction with electronegative waveform, and progressive cone degeneration. Conclusions and importance: Patients with HVDAS are known to have abnormal visual behavior due to refractive or cortical impairment. However, we present the first description, to our knowledge, of an association with retinal mal-development and degeneration. Thus, patients with HVDAS should be referred for ophthalmic genetics evaluation, and HVDAS should be on the differential diagnosis for young children with global developmental delay who present with nystagmus, rod and cone dysfunction with electronegative waveform, and relative lack of severe structural degeneration on optical coherence tomography. Keywords: Helsmoortel-Van der Aa Syndrome, HVDAS, Activity-dependent neuroprotective protein, ADNP, Nystagmus, Retinal degeneration, Electronegative waveform, Optical coherence tomography

Diagnosis, treatment, and outcome of and risk factors for ophthalmic disease in leopard geckos (Eublepharis macularius) at a veterinary teaching hospital: 52 cases (1985-2013).

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Wiggans, K Tomo; Sanchez-Migallon Guzman, David; Reilly, Christopher M; Vergneau-Grosset, Claire; Kass, Philip H; Hollingsworth, Steven R

2018-02-01

OBJECTIVE To describe diagnosis, treatment, and outcome of and risk factors for ophthalmic disease in leopard geckos (Eublepharis macularius) evaluated at a veterinary teaching hospital. DESIGN Retrospective case series. ANIMALS 112 of 144 (78%) leopard geckos that were evaluated at a veterinary teaching hospital in January 1985 through October 2013 and for which sufficient medical record information was available. PROCEDURES Information from medical records was used to identify leopard geckos with ophthalmic disease, characterize cases, and determine risk factors for the presence of ophthalmic disease. RESULTS Of the 112 leopard geckos, 52 (46%) had ophthalmic disease (mainly corneal or conjunctival disease). Female geckos were less likely to have ophthalmic disease, and there was a positive association between increasing age and ophthalmic disease. Use of a paper towel substrate, absence of any heat source, and lack of vitamin A supplementation were positively associated with a diagnosis of ophthalmic disease. Head dysecdysis was the only concurrent disorder significantly associated with ophthalmic disease. At necropsy, 5 affected leopard geckos had squamous metaplasia of the conjunctivae. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated that ophthalmic disease is a common finding in leopard geckos. The cause of ocular surface disease in leopard geckos may be multifactorial, and hypovitaminosis A may be an important risk factor. Although animals receiving supplemental vitamin A were less likely to have ophthalmic disease, further understanding is required regarding the metabolism of and nutritional requirements for vitamin A in leopard geckos.

The international forum of ophthalmic simulation: developing a virtual reality training curriculum for ophthalmology.

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Saleh, George M; Lamparter, Julia; Sullivan, Paul M; O'Sullivan, Fiona; Hussain, Badrul; Athanasiadis, Ioannis; Litwin, Andre S; Gillan, Stewart N

2013-06-01

To investigate the effect of a structured, supervised, cataract simulation programme on ophthalmic surgeons in their first year of training, and to evaluate the level of skill transfer. Trainees with minimal intraocular and simulator experience in their first year of ophthalmology undertook a structured, sequential, customised, virtual reality (VR) cataract training programme developed through the International Forum of Ophthalmic Simulation. A set of one-handed, bimanual, static and dynamic tasks were evaluated before and after the course and scores obtained. Statistical significance was evaluated with the Wilcoxon sign-rank test. The median precourse score of 101.50/400 (IQR 58.75-145.75) was significantly improved after completing the training programme ((postcourse score: 302/400, range: 266.25-343), p<0.001). While improvement was evident and found to be statistically significant in all parameters, greatest improvements were found for capsulorhexis and antitremor training ((Capsulorhexis: precourse score=0/100, range 0-4.5; postcourse score=81/100, range 13-87.75; p=0.002), (antitremor training: precourse score=0/100, range 0-0; postcourse score=80/100, range 60.25-91.50; p=0.001)). Structured and supervised VR training can offer a significant level of skills transfer to novice ophthalmic surgeons. VR training at the earliest stage of ophthalmic surgical training may, therefore, be of benefit.

Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

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Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

2015-06-01

To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

Microsurgical treatment of carotid-ophthalmic aneurysm associated with multiple anterior and posterior circulation aneurysms

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Wang, Jiantao; Kan, Zhisheng; Wang, Shuo

2017-01-01

Abstract Background: The clipping of multiple intracranial aneurysms in 1 stage is uncommon. In this case, we report clipping of an ophthalmic aneurysm associated with multiple anterior and posterior circulation aneurysms via the Dolenc approach. Methods: The main symptoms of the patient are headache, along with nausea and vomiting. The patient's arteriogram revealed a wide-necked aneurysm of the right ophthalmic artery, an irregular aneurysm of the anterior communicating artery, and a basilar artery aneurysm. The surgical intervention for these aneurysms is a challenge because of the complex anatomical relationship with the surrounding structures. The 3 aneurysms, which were not amenable to a single intervention, were successfully clipped in 1 incision. Results: After surgery, the patient reported feeling well. One year after surgery, the patient had no SAH recurrence. Conclusions: Occasionally, surgical treatment was used even for aneurysms of the carotid-ophthalmic artery with aneurysms of anterior communicating artery and basilar artery, which are contraindicated for interventional therapy. PMID:28422878

Assessment of the tolerability profile of an ophthalmic solution of 5% glycyrrhizin and copolymer PEG/PPG on healthy volunteers and evaluation of its efficacy in the treatment of moderate to severe blepharitis

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Mencucci R

2013-07-01

Full Text Available Rita Mencucci, Eleonora Favuzza, Ugo MenchiniDepartment of Surgery and Translational Medicine – Eye Clinic, University of Florence, Florence, ItalyPurpose: To evaluate the tolerability on healthy volunteers and the efficacy on subjects affected by chronic moderate/severe blepharitis of a 5% glycyrrhizin and copolymer poly(ethylene glycol/poly(propylene glycol(PEG/PPG ophthalmic solution.Methods: The study was a randomized, controlled, open label, intra-patient monocentric study. It consisted of two different phases, the assessment of tolerability phase on 20 healthy volunteers, and the evaluation of the efficacy on 21 subjects affected by chronic moderate/severe blepharitis; the treatment period was 2 weeks, followed by 1-week of follow-up. In the efficacy phase, in both eyes, eyelid hygiene was also performed. At day 0, 3, 7, 14, and 21 a complete ophthalmological examination was performed. In the tolerability phase, signs of clinical toxicity were recorded and subject-reported symptoms were collected using a questionnaire. In the efficacy phase, global signs and symptoms of blepharitis scores were collected using standardized photographic scales and questionnaire. The statistical analysis was performed using the Wilcoxon signed-rank test. Results: No ocular signs of drug toxicity were reported. During the treatment period for tolerability phase, there were statistically significant higher scores of tearing and ocular discomfort in the tolerability study group versus the tolerability control group. In the efficacy phase, differences between global scores of the two groups were statistically significant at day 0 (score of the efficacy study group was higher than the efficacy control group; P = 0.005 and at day 21 (score of the efficacy study group was lower than the efficacy control group (P ≤ 0.001.The difference of global scores at day 3, 7, 14, and 21 versus day 0 was statistically significant in both groups. No serious adverse events

21 CFR 524.390d - Chloramphenicol-prednisolone ophthalmic ointment.

Science.gov (United States)

2010-04-01

.... 017030 in § 510.600(c) of this chapter. (c) Conditions of use. Dogs and cats—(1) Amount. Apply 4 to 6...) Limitations. Therapy for cats should not exceed 7 days, prolonged use in cats may produce blood dyscrasia. As... institute appropriate therapy. All topical ophthalmic preparations containing corticosteroids, with or...

Cytotoxicity and mutagenicity of opthalmic solution preservatives and UVA radiation in L5178Y cells

International Nuclear Information System (INIS)

Withrow, T.J.; Brown, N.T.; Hitchins, V.M.; Strickland, A.G.

1989-01-01

Four preservatives used in ophthalmic solutions were tested for toxic and mutagenic potential in mouse lymphoma cells with and without exposure of cells to ultraviolet A (UVA) radiation. The preservatives tested were benzalkonium chloride (BAK), chlorhexidine, thimerosal and ethylenediaminetetraacetic acid (EDTA). Cell survival and mutagenesis were measured using the L5178Y mouse lymphoma (TK +/- ) system. Cells were exposed to varying amounts of preservatives for 1 h at 37 0 C, and aliquots irradiated with UVA radiation (during exposure to preservative). Cells were then assayed for survival, and mutagenesis at the thymidine kinase (TK) locus. In concentrations commonly found in ophthalmic solutions, BAK, chlorhexidine, and thimerosal were toxic to cells, and thimerosal was slightly mutagenic. When cells were exposed to preservative and UVA radiation, chlorhexidine was mutagenic and the mutagenic activity of thimerosal was enhanced. (author)

Cytotoxicity and mutagenicity of opthalmic solution preservatives and UVA radiation in L5178Y cells

Energy Technology Data Exchange (ETDEWEB)

Withrow, T.J.; Brown, N.T.; Hitchins, V.M.; Strickland, A.G. (Food and Drug Administration, Rockville, MD (USA). Center for Devices and Radiological Health)

1989-09-01

Four preservatives used in ophthalmic solutions were tested for toxic and mutagenic potential in mouse lymphoma cells with and without exposure of cells to ultraviolet A (UVA) radiation. The preservatives tested were benzalkonium chloride (BAK), chlorhexidine, thimerosal and ethylenediaminetetraacetic acid (EDTA). Cell survival and mutagenesis were measured using the L5178Y mouse lymphoma (TK{sup +/-}) system. Cells were exposed to varying amounts of preservatives for 1 h at 37{sup 0}C, and aliquots irradiated with UVA radiation (during exposure to preservative). Cells were then assayed for survival, and mutagenesis at the thymidine kinase (TK) locus. In concentrations commonly found in ophthalmic solutions, BAK, chlorhexidine, and thimerosal were toxic to cells, and thimerosal was slightly mutagenic. When cells were exposed to preservative and UVA radiation, chlorhexidine was mutagenic and the mutagenic activity of thimerosal was enhanced. (author).

The Use of Flow Diverting Stents to Treat Para-Ophthalmic Aneurysms

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Pervinder Bhogal

2017-08-01

Full Text Available Background and purposeFew publications have dealt exclusively with the use of flow diverter stents for the treatment of para-ophthalmic aneurysms. We sought to determine the efficacy of flow diverting stents (FDSs to treat aneurysms in this specific location.MethodsWe retrospectively reviewed our database of prospectively collected information for all patients treated with flow diversion for an unruptured saccular para-ophthalmic aneurysm between September 2009 and January 2016. The aneurysm fundus size, neck size, number and type of FDS, complications, and follow-up data were recorded.ResultsWe identified 74 patients that matched our inclusion criteria. Of these patients, 18 patients were male (24.3%. The average fundus size was 4.8 mm, 11 aneurysms had previous coil occlusions and 63 were treated solely with flow diversion. At an initial angiographic follow-up (mean avg. 3.2 months, 71.8% of the aneurysms were occluded, and at the last follow-up (mean avg. 31.8 months, 88.9% of aneurysms were occluded. One patient suffered permanent morbidity (1.36% secondary to interruption of the antiplatelet medication and another died (1.36% secondary to in-stent thrombosis that was also due to an interruption in the antiplatelet medication.ConclusionTreatment of saccular para-ophthalmic aneurysms with FDS is feasible and carries a high degree of technical success with low complication rates and excellent rates of aneurysm exclusion.

Cell viability score as an integrated indicator for cytotoxicity of benzalkonium chloride-containing antiglaucoma eyedrops.

Science.gov (United States)

Ayaki, Masahiko; Iwasawa, Atsuo; Niwano, Yoshimi

2012-01-01

We evaluated the in vitro cytotoxicity of benzalkonium chloride (BAK)-containing antiglaucoma eyedrops. We prepared cell cultures of SIRC, BCE C/D-1b, RC-1, and Chang conjunctiva. The viability of cell cultures was determined using the MTT and neutral red assays. The cell viability score (CVS) was used to compare the toxicity of test solutions. %CVS50 and %CVS40/80 of each eyedrop solution were 71 and 26 for Lumigan(®) (0.002% bimatoprost with 0.005% BAK), 100 and 99 for Tapros(®) (0.0015% tafluprost, a new formula from 2010 with 0.001% BAK), 39 and -29 for 2% Trusopt(®) (2% dorzolamide with 0.0075% BAK), 28 and -43 for Xalacom(®) (latanoprost/0.5% timolol with 0.02% BAK), 88 and 66 for DuoTrav(®) (travoprost/0.5% timolol with no BAK), 36 and -35 for Cosopt(®) (2% dorzolamide/0.5% timolol with 0.0075% BAK) and 53 and -1 for Combigan(®) (0.15% brimonidin/0.5% timolol with 0.005% BAK). Only Xalacom(®) and Tapros(®) did not show an apparent decrease in %CVS as compared to the corresponding concentration of BAK. In conclusion, the cytotoxicity of tested eyedrops was dependent on BAK. Only the eyedrops containing latanoprost or tafluprost showed a reduction in the cytotoxicity of BAK.

Ophthalmic epidemiology in Europe

DEFF Research Database (Denmark)

Delcourt, Cécile; Korobelnik, Jean-François; Buitendijk, Gabriëlle H S

2016-01-01

The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170,000 Euro......The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170......,000 European participants. The aim of the consortium is to promote and sustain collaboration and sharing of data and knowledge in the field of ophthalmic epidemiology in Europe, with particular focus on the harmonization of methods for future research, estimation and projection of frequency and impact...

Long-term ophthalmic health care in Usher syndrome type I from an ICF perspective.

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Möller, Kerstin; Eriksson, Kristina; Sadeghi, André M; Möller, Claes; Danermark, Berth

2009-01-01

The aim was to explore ophthalmic health care in female patients with Usher Syndrome type I (USH I) over 20 years and to evaluate the relationship between the ophthalmic health care and the health state of the patients from a health perspective. A retrospective study of records from ophthalmology departments (OD) and low vision clinics (LVC) from 1985 to 2004. Assessment of the reports was performed based on the International Classification of Functioning, Disability and Health (ICF). Findings were analysed by manifest content analysis with ICF as a framework and using four themes: health care system, procedure examinations, patient's functioning and disability and procedure actions. The records of nine female patients (aged 25-39 years, 1985) with USH I were selected from the national database of USH. A great number of notes were collected (OD 344 and LVC 566). Procedure examinations were exclusively oriented towards body structure and function. All patients showed aggravated visual impairment over and above the hearing and vestibular impairment. Procedure actions were oriented towards environmental factors. No correlation was found between procedures performed and patient's experience of disability. The high degree of resource allocation was not correlated to the patients' impairment. The study indicates that the ophthalmic health care was characterised by inefficiency. This conclusion is very serious because patients very likely face severe disability and emotional difficulties. ICF is ought to be incorporated in ophthalmic health care strategy to improve the health care.

Ocular and systemic pharmacokinetics of lidocaine hydrochloride ophthalmic gel in rabbits after topical ocular administration.

Science.gov (United States)

Liu, Bing; Ding, Li; Xu, Xiaowen; Lin, Hongda; Sun, Chenglong; You, Linjun

2015-12-01

Lidocaine hydrochloride ophthalmic gel is a novel ophthalmic preparation for topical ocular anesthesia. The study is aimed at evaluating the ocular and systemic pharmacokinetics of lidocaine hydrochloride 3.5 % ophthalmic gel in rabbits after ocular topical administration. Thirty-six rabbits were randomly placed in 12 groups (3 rabbits per group). The rabbits were quickly killed according to their groups at 0 (predose), 0.0833, 0.167, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, and 8 h postdose and then the ocular tissue and plasma samples were collected. All the samples were analyzed by a validated LC-MS/MS method. The test result showed that the maximum concentration (C max) of lidocaine in different ocular tissues and plasma were all achieved within 20 min after drug administration, and the data of C max were (2,987 ± 1814) μg/g, (44.67 ± 12.91) μg/g, (26.26 ± 7.19) μg/g, (11,046 ± 2,734) ng/mL, and (160.3 ± 61.0) ng/mL for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The data of the elimination half-life in these tissues were 1.5, 3.2, 3.5, 1.9, and 1.7 h for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The intraocular lidocaine levels were significantly higher than that in plasma, and the elimination half-life of lidocaine in cornea, conjunctiva, and aqueous humor was relatively longer than that in tear fluid and plasma. The high intraocular penetration, low systemic exposure, and long duration in the ocular tissues suggested lidocaine hydrochloride 3.5 % ophthalmic gel as an effective local anesthetic for ocular anesthesia during ophthalmic procedures.

Paradigm Shifts in Ophthalmic Diagnostics.

Science.gov (United States)

Sebag, J; Sadun, Alfredo A; Pierce, Eric A

2016-08-01

Future advances in ophthalmology will see a paradigm shift in diagnostics from a focus on dysfunction and disease to better measures of psychophysical function and health. Practical methods to define genotypes will be increasingly important and non-invasive nanotechnologies are needed to detect molecular changes that predate histopathology. This is not a review nor meant to be comprehensive. Specific topics have been selected to illustrate the principles of important paradigm shifts that will influence the future of ophthalmic diagnostics. It is our impression that future evaluation of vision will go beyond visual acuity to assess ocular health in terms of psychophysical function. The definition of disease will incorporate genotype into what has historically been a phenotype-centric discipline. Non-invasive nanotechnologies will enable a paradigm shift from disease detection on a cellular level to a sub-cellular molecular level. Vision can be evaluated beyond visual acuity by measuring contrast sensitivity, color vision, and macular function, as these provide better insights into the impact of aging and disease. Distortions can be quantified and the psychophysical basis of vision can be better evaluated than in the past by designing tests that assess particular macular cell function(s). Advances in our understanding of the genetic basis of eye diseases will enable better characterization of ocular health and disease. Non-invasive nanotechnologies can assess molecular changes in the lens, vitreous, and macula that predate visible pathology. Oxygen metabolism and circulatory physiology are measurable indices of ocular health that can detect variations of physiology and early disease. This overview of paradigm shifts in ophthalmology suggests that the future will see significant improvements in ophthalmic diagnostics. The selected topics illustrate the principles of these paradigm shifts and should serve as a guide to further research and development. Indeed

Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

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Walimbe T

2016-05-01

Full Text Available Tejaswini Walimbe,1 Vidya Chelerkar,2 Purvi Bhagat,3 Abhijeet Joshi,4 Atul Raut4 1Walimbe Eye Clinic, 2PBMA’s H.V. Desai Eye Hospital, Pune, 3Glaucoma Clinic, M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, 4Clinical Research Department, Sun Pharma Advanced Research Company Ltd., Mumbai, India Introduction: Benzalkonium chloride (BAK, included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT. BAK-containing latanoprost, an ester prodrug of prostaglandin F2a, can cause ocular adverse events (AEs associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost. Patients and methods: A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively. Results: At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001. Ocular Surface Disease Index© (OSDI© score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001. In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033. A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08% treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes

Effects of 3% diquafosol sodium ophthalmic solution on higher-order aberrations in patients diagnosed with dry eye after cataract surgery.

Science.gov (United States)

Inoue, Yasushi; Ochi, Shintarou

2017-01-01

To evaluate the effects of diquafosol sodium ophthalmic solution 3% (DQS) and artificial tears (AT) on higher-order aberrations (HOAs) in patients with dry eye after cataract surgery. This was a post hoc analysis of a previously conducted randomized clinical study. Fifty-nine eyes from 42 patients (17 males and 25 females, aged 72.6±8.0 years) with verified or suspected dry eye at 4 weeks after cataract surgery were evaluated. The dry eye patients were randomly assigned to receive DQS or AT for 4 weeks. Tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, and HOAs were analyzed before and after instillation. HOAs were measured consecutively for 10 seconds with a wavefront analyzer. Average HOAs, HOA fluctuations (fluctuation index [FI]) and changes in HOAs (stability index [SI]) were compared within and between the two groups. After 4 weeks of instillation, BUT significantly increased ( P =0.001) compared with preinstillation values in the DQS group, but not in the AT group. This increase in BUT in the DQS group was significantly greater than in the AT group ( P =0.014). Corneal and conjunctival fluorescein staining scores after instillation significantly improved compared with preinstillation values in the DQS group ( P =0.018). In HOAs, the cornea aberration changed from an upward curve (a sawtooth pattern) to an almost constant value (a stable pattern) in the DQS group, but not in the AT group. In FI and SI, there were no significant changes in either group; however, FI and SI were significantly lower in the DQS group than in the AT group (both, P =0.004). The dry eye patients after cataract surgery had a visual dysfunction in HOAs. DQS is effective to treat dry eye disease after cataract surgery with improvement of visual function.

Generic versus brand-name North American topical glaucoma drops.

Science.gov (United States)

Mammo, Zaid N; Flanagan, John G; James, David F; Trope, Graham E

2012-02-01

To determine whether brand-name glaucoma drops differ from generic equivalents in bottle design, viscosity, surface tension, and volume in North America. Experimental study. We studied 5 bottles each of 11 kinds of glaucoma drops. Density-based calculations of drop volume were assessed using 0.1 mg analytic balance. Viscosity was measured using rotational rheometery. Bottle tip diameter was measured using 0.05 mm Vernier calipers. Surface tension was measured using a Fisher Scientific (Ottawa, ON) tensiometer. For the American brand-name Timoptic XE, the average drop volume was 38 ± 3.1 μL versus 24 ± 1.5 μL of Timolol GFS (p brand-name Timoptic XE, the average drop volume was 42 ± 4.0 μL versus 25 ± 2 μL of timolol maleate EX (p brand-name Timoptic drop volume was 28 ± 1.4 μL versus 35 ± 1.9 μL Apo-Timop (p brand-name Timoptic delivered significantly smaller drop volumes than generic Apo-Timop. Careful consideration should be given to drop viscosity and bottle design when generic ophthalmic products are evaluated for interchangeability and market entry. Copyright © 2012 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Application and study of conjunctival sac disinfectants in ophthalmic surgeries

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Yan-Fei Luo

2016-01-01

Full Text Available Postoperative endophthalmitis is the most serious complications of ophthalmic surgeries. Conjunctival sac disinfection is currently recognized as an effectively important way to reduce the risk of endophthalmitis. At present, there are some disinfectants has been used in clinic or in the researches:mercury agent, gentamicin, povidone iodine and acid electrolytic water. All kinds of disinfectants play the role of disinfection by different ways. Povidone iodine is the most widely used conjunctival sac disinfectant. Mercurial and gentamicin have been rarely used because they pollute the environment, are easy to cause drug resistant bacteria, localized side reactions and so on. The acid electrolyte water is not used in clinic at present. With the popularization and development of the ophthalmic surgeries, the ophthalmologists have become more and more concerned about the postoperative eye comfort, the research and application of conjunctival sac disinfectant in the future will continue to be updated and developed.

Optimization and evaluation of thermoresponsive diclofenac sodium ophthalmic in situ gels.

Science.gov (United States)

Asasutjarit, Rathapon; Thanasanchokpibull, Suthira; Fuongfuchat, Asira; Veeranondha, Sukitaya

2011-06-15

This work was conducted to optimize and evaluate Pluronic F127-based thermoresponsive diclofenac sodium ophthalmic in situ gels (DS in situ gel). They were prepared by cold method and investigated their physicochemical properties i.e., pH, flow ability, sol-gel transition temperature, gelling capacity and rheological properties. An optimized formulation was selected and investigated its physicochemical properties before and after autoclaving, eye irritation potency in SIRC cells and rabbits. In vivo ophthalmic absorption was performed in rabbits. It was found that physicochemical properties of DS in situ gels were affected by formulation compositions. Increment of Pluronic F127 content decreased sol-gel transition temperature of the products while increase in Pluronic F68 concentration tended to increase sol-gel transition temperature. In this study, Carbopol 940 did not affect sol-gel transition temperature but it affected transparency, pH, and gelling capacity of the products. The optimized formulation exhibited sol-gel transition at 32.6 ± 1.1 °C with pseudoplastic flow behavior. It was lost diclofenac sodium content during autoclaving. However, it was accepted as safe for ophthalmic use and could increase diclofenac sodium bioavailability in aqueous humor significantly. In conclusion, the optimized DS in situ gel had potential for using as an alternative to the conventional diclofenac sodium eye drop. However, autoclaving was not a suitable sterilization method for this product. Copyright © 2011 Elsevier B.V. All rights reserved.

[Sinus pericranii associated to spontaneous thrombosis of the ophthalmic vein: neuroimaging studies].

Science.gov (United States)

Murias, E; Villota, E; Saiz, A; Gil, A; Calleja, S

2009-01-01

Sinus pericranii is an abnormal venous communication between the intracranial dural sinuses and epicranial venous dilatations. The periorbital location is uncommon; spontaneous partial thromboses of the subcutaneous varices have been reported in association with local signs and symptoms; however, to our knowledge there are no reports of sinus pericranii associated to thrombosis in the ophthalmic vein. Sinus pericranii is related to arteriovenous and lymphatic-venous malformations. We present the case of a patient with a generalized and diffuse disorder of venous drainage that affected the right cerebral hemisphere who presented at the emergency department with ophthalmologic signs and symptoms after thrombosis of the superior ophthalmic vein and who had three sinus pericranii located in the frontal, parietal, and occipital areas.

Stability-indicating liquid Chromatographic assaymethod for Opthalmic solutions containing combination of Dexamethasone and Chloramphenicol

International Nuclear Information System (INIS)

Rao, R.M.; Al-Ashban, R.M.; Shah, A.H.

2004-01-01

A selective high-performance chromatographic procedure for the stability monitoring of ophthalmic solutions containing a combination of dexamethasone and chloramphenicolis demonstrated. The separation of the active components and the degradation product of chloramphenicol (1-amino-1-(4-nitrophenyl)-propane-1, 3diol) was achieved on a u-Bondapack C-18 column ( 5 um, 300 mm x 3.9 mm) maintained at ambient temperature (15-20C) by utilizing a mobile phase consisting acidified water (5% actified water with glacial acetic acid ) : acetonitrile : triethyl amine 700 : 300 : 2and pH was adjusted to 5.0 by using 10 M Na OH. The flow rate was 1.5 ml min-1; and elutes were followed with UV-detection at 254 nm. Complete resolution of dexamethasone, chloramphenicol and its hydrolytic product could be attained. The sensitivity, accuracy and specificity were tested. The method was successfully applied in post-marketing stability of the commercial batches of ophthalmic solutions. (author)

Ophthalmic manifestations of methylmalonic aciduria accompanied with homocystinuria

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Qiu-Jing Huang

2015-12-01

Full Text Available Methylmalonicaciduia(MMAaccompanied with homocystinuria is a rare autosomal-recessive with congenital metabolic disorder of Vitamin B12. There are three subtypes, cblC, cblD, cblF, in which cblC is the most common one. The diagnostic tests are tandem mass spectrometry and gas chromatography-mass spectrometry. Tests for activity of enzyme in fibroblasts from skin, complementary assay and genetic analysis can be used to make the subtype clear. Early-onset patients, defined by onset of symptoms before the age of 1 year, may have severe ocular involvement, including visual loss, nystagmus, strabismus, retinopathy, maculopathy, optic atrophy, abnormal electroretinography. Late-onset patients, defined by onset of symptoms after the age of 4 year, rarely have ocular manifestations. The pathogenesis of the ophthalmic symptoms may be related to the high level of homocystine, oxidative stress and the abnormal development of nervous systems. The treatment for MMA accompanied with homocystinuria is mostly symptomatic based. Ophthalmic treatment is limited. Early supplement of methionine,GSH or other antioxidants may be helpful for retinopathy. There is no standard ophthalmological examination for those patients in China. It is critical to set up inter-departmental cooperation and early stage examination for the treatments and outcomes of the patients.

Ophthalmic Skills Assessment of Primary Health Care Workers at ...

African Journals Online (AJOL)

Proficiency in the basic ophthalmic skills is a cri cal factor in the effec ve delivery of eye care services at the primary level of care. The aim of the study was to assess the ability of ... out visual acuity test and correctly iden fy cataract and conjunc vi s using pictures of eye condi ons and ..... Medical Laboratory Technician.

Ocular pharmacokinetics of bimatoprost formulated in DuraSite compared to bimatoprost 0.03% ophthalmic solution in pigmented rabbit eyes

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Shafiee A

2013-07-01

Full Text Available Afshin Shafiee,1 Lyle M Bowman,2 Eddie Hou,2 Kamran Hosseini1,3 1Preclinical, 2Development, 3Clinical, InSite Vision, Alameda, CA, USA Purpose: To compare the aqueous humor (AH and iris-ciliary body (ICB concentration of bimatoprost in rabbit eyes treated with ISV-215 (0.03% bimatoprost formulated in DuraSite with the marketed product bimatoprost 0.03% ophthalmic solution. Methods: The left eye of rabbits received a single topical instillation of either ISV-215 (n = 32 eyes or bimatoprost 0.03% (n = 32 eyes. At predetermined time points, levels of bimatoprost and bimatoprost acid in the AH and the ICB were quantified by HPLC-MS/MS. Results: Both bimatoprost and bimatoprost acid were detected in the AH and the ICB within 15 minutes of dosing. Bimatoprost acid concentrations in both compartments were markedly higher than bimatoprost. There was a statistically significant (P < 0.01 increase in the concentration of the prodrug in the AH and its acid form in the ICB in animals treated with ISV-215 compared to bimatoprost 0.03%. In the ISV-215-treated rabbit eyes, the highest concentrations of bimatoprost and bimatoprost acid were in the ICB and AH, respectively, while in the bimatoprost 0.03%-treated eyes, no differences in the drug content of the selected ocular tissues were observed. Conclusions: Bimatoprost 0.03% formulated in DuraSite has superior ocular distribution and area under the curve compared to bimatoprost 0.03% in rabbit eyes. This improvement in the pharmacokinetic parameters of ISV-215 may provide us with a better platform to optimize a bimatoprost formulation that offers the same degree of efficacy in lowering intraocular pressure and improved therapeutic index in glaucomatous patients by lessening the ocular side effects associated with long-term use of topical prostaglandin F2α analogs. Keywords: drug delivery, intraocular pressure, glaucoma, aqueous humor, prostaglandin (PGF2α analogs

Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

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Shen, Jie; Goodkin, Margot L; Tong, Warren; Attar, Mayssa

2017-01-01

Purpose Fixed-combination medications can benefit patients requiring multiple agents to lower their intraocular pressure (IOP), but combining agents with complementary mechanisms of action is challenging if their dosing frequency differs. This study compares in vivo pharmacokinetic and ocular tolerability of bimatoprost 0.01% ophthalmic solutions dosed once or twice daily. Reports of twice-daily dosing in glaucoma patients are also reviewed. Methods New Zealand White rabbits were administered bimatoprost 0.01% monotherapy or fixed-combination bimatoprost 0.01%/brimonidine 0.1%, once or twice daily in both eyes for 4 days. Ocular tissues were harvested and analyzed by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters calculated included maximum observed concentration, time to maximum concentration, and area under the concentration-time curve. Results Due to extensive metabolism, bimatoprost concentration was below the quantitation limit by 1 hour post-dose in all samples. Bimatoprost acid exposure, however, could be measured up to 6–8 hours post-dose and was similar in the aqueous humor and iris-ciliary body (pharmacological site of action) of animals treated once or twice daily with either bimatoprost 0.01% or fixed-combination bimatoprost 0.01%/brimonidine 0.1%. Increasing dosage frequency in rabbits did not raise the incidence of drug-related conjunctival hyperemia (most common adverse event associated with bimatoprost use in humans), suggesting comparable ocular tolerability of the once- and twice-daily regimens for each formulation. Conclusion Bimatoprost 0.01% administered once or twice daily as monotherapy and in fixed-combination with brimonidine 0.1% in rabbits show similar pharmacokinetic profiles of bimatoprost acid, especially in the iris-ciliary body. Key findings from previous clinical studies suggest that by varying the concentration of benzalkonium chloride (a preservative with corneal penetration-enhancing properties

Common causes of red eye presenting at an ophthalmic clinic ...

African Journals Online (AJOL)

Background: Redness of the eye is a common ophthalmic symptom. The problem causing redness could arise from within or outside the globe. These range from cases of simple inflammation following itching and minor trauma for example, to severe cases like orbital cellulitis and tumours. Patients may not even be aware of ...

Efficacy of detergent and water versus bleach for disinfection of direct contact ophthalmic lenses.

Science.gov (United States)

Abbey, Ashkan M; Gregori, Ninel Z; Surapaneni, Krishna; Miller, Darlene

2014-06-01

Although manufacturers recommend cleaning ophthalmic lenses with detergent and water and then with a specific disinfectant, disinfectants are rarely used in ophthalmic practices. The aim of this pilot study was to evaluate the efficacy of detergent and water versus that of bleach, a recommended disinfectant, to eliminate common ocular bacteria and viruses from ophthalmic lenses. Three bacterial strains (Staphylococcus epidermidis, Corynebacterium straitum, and methicillin-resistant Staphylococcus aureus and 2 viral strains (adenovirus and herpes simplex virus [HSV] type-1) were individually inoculated onto 20 gonioscopy and laser lenses. The lenses were washed with detergent and water and then disinfected with 10% bleach. All the lenses were cultured after inoculation, after washing with detergent and water, and after disinfecting with the bleach. Bacterial cultures in thioglycollate broth were observed for 3 weeks, and viral cultures were observed for 2 weeks. The presence of viruses was also detected by multiplex polymerase chain reaction (PCR). All 20 lenses inoculated with S. epidermidis, C. straitum, adenovirus, and HSV-1 showed growth after inoculation but no growth after washing with detergent/water and after disinfecting with the bleach. All lenses showed positive HSV and adenovirus PCR results after inoculation and negative PCR results after washing with detergent/water and after disinfecting with bleach. All methicillin-resistant S. aureus-contaminated lenses showed growth after inoculation and no growth after washing with detergent and water. However, 1 lens showed positive growth after disinfecting with bleach. Cleaning with detergent and water seemed to effectively eliminate bacteria and viruses from the surface of contaminated ophthalmic lenses. Further studies are warranted to design practical disinfection protocols that minimize lens damage.

Relationship between the Direction of Ophthalmic Artery Blood Flow and Ocular Microcirculation before and after Carotid Artery Stenting.

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Ishii, Masashi; Hayashi, Morito; Yagi, Fumihiko; Sato, Kenichiro; Tomita, Goji; Iwabuchi, Satoshi

2016-01-01

When internal carotid artery stenosis is accompanied by ocular ischemic syndrome, intervention is recommended to prevent irreversible visual loss. In this study, we used laser speckle flowgraphy to measure the ocular microcirculation in the optic nerve head before and after carotid artery stenting (CAS) of 40 advanced internal carotid stenosis lesions from 37 patients. The aim was to investigate the relationship between ocular microcirculation and the direction of ophthalmic artery blood flow obtained by angiography. We found that there was a significant increase in blood flow after CAS ( P = 0.003). Peak systolic velocity as an indicator of the rate of stenosis was also significantly higher in the group with retrograde/undetected flow of the ophthalmic artery than in the group with antegrade flow ( P = 0.002). In all cases where retrograde flow of the ophthalmic artery was observed before stenting, the flow changed to antegrade after stenting. Through the use of laser speckle flowgraphy, this study found that CAS can improve ocular microcirculation. Furthermore, while patients displaying retrograde flow of the ophthalmic artery before stenting have a poor prognosis, CAS corrected the flow to antegrade, suggesting that visual loss can be prevented by improving the ocular microcirculation.

The impact of the European Working Time Regulations on Ophthalmic Specialist Training--a national trainee survey.

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O'Gallagher, M K; Lewis, G; Mercieca, K; Moutray, T

2013-01-01

To assess ophthalmic trainees' perspective of the impact of the European Working Time Regulations (EWTR) on their training. All trainees in ophthalmology in the UK were emailed a link to an electronic survey asking about their experiences of the EWTR. 324 trainees (46% of those invited) responded to the survey. 44.4% of trainees reported that their posts were compliant with the EWTR. 40.7% felt that training had been adversely affected. 49.1% thought that ophthalmic trainees should opt out of the EWTR to work more than 48 h per week, with 57 the mean number of hours suggested appropriate. Many ophthalmic trainees in the United Kingdom are working in rotas which are not compliant with the European Working Time Directive. Many trainees feel that implementation of the EWTD has had a negative effect on training and feel it would be acceptable to work a higher number of hours per week. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

OPHTHALMIC FINDINGS IN LATE STAGE SJOGREN-LARSSON SYNDROME.

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Nanda, Tavish; Kovach, Jaclyn L

2017-03-15

To report spectral domain optical coherence tomography and fundus autofluorescence documentation of late stage macular findings associated with Sjogren-Larsson Syndrome in three adult siblings. Three adult siblings with Sjogren-Larsson Syndrome underwent ophthalmic examination and imaging. Crystalline maculopathy and subretinal deposits, presumably lipofuscin accumulation, with macular atrophy were present in varying degrees in all three adult siblings. In adults with Sjogren-Larsson Syndrome, crystalline retinopathy can progress to macular atrophy and the appearance of lipofuscin accumulation.

The Efficacy of Diquafosol Ophthalmic Solution in Non-Sjögren and Sjögren Syndrome Dry Eye Patients Unresponsive to Artificial Tear.

Science.gov (United States)

Jeon, Hyun Sun; Hyon, Joon Young

2016-09-01

This study evaluates the efficacy of 3% diquafosol tetrasodium ophthalmic solution in Sjögren's syndrome (SS) and non-SS dry eye patients unresponsive to conventional artificial tear. This retrospective study included 38 dry eye patients (11 with SS and 27 with non-SS) who were treated with 3% diquafosol due to lack of response to artificial tear treatment for more than 3 months. Signs such as tear film break-up time (TBUT), Schirmer-I test, and total ocular staining score (OSS), which consisted of corneal OSS and conjunctival OSS, were evaluated at baseline and the first visit after treatment. Symptoms were quantified using visual analog scale (VAS) and ocular surface disease index (OSDI) scores. Changes of parameters after treatment in all the patients and differences of changes in SS and non-SS were evaluated. In total population, total OSS and corneal OSS improved average 6 weeks after diquafosol treatment (all P < 0.05, paired t-test), although conjunctival OSS had no improvement. TBUT increased after treatment (P = 0.036), while Schirmer-I test, OSDI, and VAS showed no improvement. With respect to comparisons, total and corneal OSS improved in non-SS patients and TBUT improved in SS patients (all P < 0.05). Three percent diquafosol tetrasodium treatment could be considered as an additive or substitute treatment when artificial tear treatment is insufficient, as it improved OSS and TBUT. This study also demonstrated that diquafosol treatment is beneficial for TBUT improvement in SS, while it is beneficial for OSS improvement in non-SS dry eye patients.

Efficacy of Detergent and Water Versus Bleach for the Disinfection of Direct Contact Ophthalmic Lenses

Science.gov (United States)

Abbey, Ashkan M.; Gregori, Ninel Z.; Surapaneni, Krishna; Miller, Darlene

2014-01-01

Purpose While manufacturers recommend cleaning ophthalmic lenses with detergent and water and then a specific disinfectant, disinfectants are rarely used in ophthalmic practices. The aim of this pilot study was to evaluate the efficacy of detergent and water versus bleach, a recommended disinfectant, to eliminate common ocular bacteria and viruses from ophthalmic lenses. Methods Three bacterial strains (Staphylococcus epidermidis, Corynebacterium straitum, and methicillin-resistant Staphylococcus aureus (MRSA) and two viral strains (adenovirus and herpes simplex virus (HSV) type-1) were individually inoculated to 20 gonioscopy and laser lenses. Lenses were washed with detergent and water and then disinfected with 10% bleach. All lenses were cultured after inoculation, after detergent and water, and after the bleach. Bacterial cultures in thioglycollate broth were observed for 3 weeks and viral cultures for 2 weeks. The presence of viruses was also detected by multiplex polymerase chain reaction (PCR). Results All 20 lenses inoculated with Staphylococcus epidermidis, Corynebacterium straitum, adenovirus, and HSV-1 showed growth after inoculation, but no growth after detergent/water and after the bleach. All lenses showed positive HSV and adenovirus PCR after inoculation and negative PCR after detergent/water and after bleach. All MRSA contaminated lenses showed growth after inoculation and no growth after detergent and water. However, one lens showed positive growth after bleach. Conclusions Cleaning with detergent and water appeared to effectively eliminate bacteria and viruses from the surface of contaminated ophthalmic lenses. Further studies are warranted to design practical disinfection protocols that minimize lens damage. PMID:24747806

Deep lateral wall orbital decompression following strabismus surgery in patients with Type II ophthalmic Graves' disease.

Science.gov (United States)

Ellis, Michael P; Broxterman, Emily C; Hromas, Alan R; Whittaker, Thomas J; Sokol, Jason A

2018-01-10

Surgical management of ophthalmic Graves' disease traditionally involves, in order, orbital decompression, followed by strabismus surgery and eyelid surgery. Nunery et al. previously described two distinct sub-types of patients with ophthalmic Graves' disease; Type I patients exhibit no restrictive myopathy (no diplopia) as opposed to Type II patients who do exhibit restrictive myopathy (diplopia) and are far more likely to develop new-onset worsening diplopia following medial wall and floor decompression. Strabismus surgery involving extra-ocular muscle recession has, in turn, been shown to potentially worsen proptosis. Our experience with Type II patients who have already undergone medial wall and floor decompression and strabismus surgery found, when additional decompression is necessary, deep lateral wall decompression (DLWD) appears to have a low rate of post-operative primary-gaze diplopia. A case series of four Type II ophthalmic Graves' disease patients, all of whom had already undergone decompression and strabismus surgery, and went on to develop worsening proptosis or optic nerve compression necessitating further decompression thereafter. In all cases, patients were treated with DLWD. Institutional Review Board approval was granted by the University of Kansas. None of the four patients treated with this approach developed recurrent primary-gaze diplopia or required strabismus surgery following DLWD. While we still prefer to perform medial wall and floor decompression as the initial treatment for ophthalmic Graves' disease, for proptosis following consecutive strabismus surgery, DLWD appears to be effective with a low rate of recurrent primary-gaze diplopia.

Digital video recording and archiving in ophthalmic surgery

Directory of Open Access Journals (Sweden)

Raju Biju

2006-01-01

Full Text Available Currently most ophthalmic operating rooms are equipped with an analog video recording system [analog Charge Couple Device camera for video grabbing and a Video Cassette Recorder for recording]. We discuss the various advantages of a digital video capture device, its archiving capabilities and our experience during the transition from analog to digital video recording and archiving. The basic terminology and concepts related to analog and digital video, along with the choice of hardware, software and formats for archiving are discussed.

10 CFR 35.491 - Training for ophthalmic use of strontium-90.

Science.gov (United States)

2010-01-01

... the requirements in paragraph (b) of this section and has achieved a level of competency sufficient to... require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who— (a) Is an...; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology...

Ophthalmic Artery Embolization as Pretreatment of Orbital Exenteration for Conjunctival Squamous Cell Carcinoma

International Nuclear Information System (INIS)

Matsuo, Toshihiko; Ohara, Nobuya; Namba, Yuzaburo; Koshima, Isao; Ida, Kentaro; Kanazawa, Susumu

2009-01-01

The aim of this study is to describe the effect of transarterial embolization from the ophthalmic artery as a pretreatment for orbital exenteration. A 75-year-old Chinese man with a 7-year history of gradual increase of the left eye swelling showed a massive conjunctival tumor growing outwardly from the interpalpebral fissure and had no light perception in the left eye. Magnetic resonance imaging showed orbital invasion of the tumor around the left eyeglobe. The initial surgery for the planned orbital exenteration was discontinued after skin incision around the orbital margin due to massive hemorrhage. The patient underwent transarterial embolization with gelatin sponge (Spongel) of the feeding arteries from the left ophthalmic artery and, the next day, had orbital exenteration with well-controllable bleeding and reconstruction with free vascularized anterolateral thigh cutaneous flap transfer. Pathologically, well-differentiated squamous cell carcinoma proliferated in exophytic, papillary, and nested fashions, arising from the bulbar conjunctiva. Tumor cells were also found in the conjunctival stroma around the vessels. The sclera at the equator had a perforated site with tumor cell invasion, but no intraocular invasion was found. Hematoxylin-positive gelatin sponges were found inside the orbital vessels and large choroidal vessels. In conclusion, transarterial embolization of feeding arteries arising from the ophthalmic artery is a useful pretreatment to control bleeding at orbital exenteration for malignancy.

Flow analysis of the ophthalmic artery

Energy Technology Data Exchange (ETDEWEB)

Harada, Kuniaki; Hashimoto, Masato; Bandoh, Michio; Odawara, Yoshihiro; Kamagata, Masaki; Shirase, Ryuji [Sapporo Medical Univ. (Japan). Hospital

2003-02-01

The purpose of this study was to analyze the hemodynamics of ophthalmic artery flow using phase contrast MR angiography (PC-MRA). A total of 14 eyes from 10 normal volunteers and a patient with normal tension glaucoma (NTG) were analyzed. The optimal conditions were time repetition (TR)/echo time (TE)/flip angle (FA)/nex=40 ms/minimum/90 deg/2, field of view (FOV)=6 cm, matrix size=256 x 256. The resistive index (RI) and pulsatillity index (PI) values were significantly raised in the patient with NTG when compared to the control group. We therefore believe that PC-MRA may be a useful clinical tool for the assessment of the mechanism of NTG. (author)

The signs of ocular-surface disorders after switching from latanoprost to tafluprost/timolol fixed combination: a prospective study

Directory of Open Access Journals (Sweden)

Okumichi H

2017-06-01

Full Text Available Hideaki Okumichi,1 Yoshiaki Kiuchi,1 Tetsuya Baba,2 Takashi Kanamoto,3 Tomoko Naito,4,5 Shunsuke Nakakura,6 Hitoshi Tabuchi,6 Hiroki Nii,7 Chie Sueoka,7 Yosuke Sugimoto1,8 1Department of Ophthalmology and Visual Science, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan; 2Shirai Eye Hospital, Mitoyo, Japan; 3Department of Ophthalmology, Hiroshima Memorial Hospital, Hiroshima, Japan; 4Department of Ophthalmology, Okayama University Graduate School of Medicine, Okayama, Japan; 5Department of Ophthalmology, Konko Hospital, Asakuchi, Japan; 6Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Japan; 7Department of Ophthalmology, Hiroshima General Hospital, Hiroshima, Japan; 8Department of Ophthalmology, Hiroshima Prefectural Hospital, Hiroshima, Japan Purpose: To evaluate the ocular-surface safety of a 0.001% benzalkonium chloride-containing tafluprost/timolol fixed combination (TTFC in patients with primary open-angle glaucoma (POAG or ocular hypertension who have inadequate intraocular pressure (IOP control with latanoprost monotherapy.Methods: This study is a multicenter, prospective, single-arm, open-label clinical study. Patients with POAG or ocular hypertension who have inadequate IOP control with latanoprost monotherapy were considered eligible. After providing informed consent, patients continued latanoprost monotherapy for 12 weeks, followed by a switch to TTFC. We evaluated the extent of ocular-surface damage using superficial punctate keratopathy (SPK score, tear breakup time (TBUT, hyperemia score, IOP, systolic blood pressure (SBP, diastolic blood pressure (DBP, and heart rate at 0, 4, and 12 weeks after switching.Results: A total of 68 patients were enrolled, of whom, 64 patients were included in the final analysis. No significant changes in SPK score, TBUT, or hyperemia score were observed at 4 and 12 weeks compared with week 0. IOP decreased significantly at 4 (13.9±2.5 mmHg and 12

[A case of ophthalmic artery occlusion following injection of hyaluronic acid into the glabellar area].

Science.gov (United States)

Nonomura, Sakiko; Oshitari, Toshiyuki; Miura, Gen; Chiba, Akihiro; Yamamoto, Shuichi

2014-09-01

We report a case of unilateral blindness due to ophthalmic artery occlusion following injection of hyaluronic acid into the glabellar area for facial soft-tissue augmentation. A 20-year old woman underwent injection of hyaluronic acid into the glabellar area at an aesthetic plastic clinic. Immediately after injection, she suffered nausea, pain, paralysis of limbs and visual loss in her right eye. Hyaluronidase was instanly injected into the same place, but these symptoms did not improve. She was transferred to our hospital's emergency department. At the first examination, she had no light perception in the right eye and her right pupil was dilated. The fundus examination revealed right central artery occlusion. No significant findings were detected in her head. Eye ball massage, hyperbaric oxygen therapy, and drip infusion of urokinase were conducted, but no improvement resulted. Fluorescein and indocyanine green angiography showed no filling of the right retinal and choroidal arteries. Electroretinogram was completely disappeared. Magnetic resonance angiography could not reveal the obstruction point of the ophthalmic artery. Ophthalmic artery occlusion was believed to have occured after injection of hyaluronic acid into the glabellar area.

Efficacy and Safety of Switching Prostaglandin Analog Monotherapy to Tafluprost/Timolol Fixed-Combination Therapy

Science.gov (United States)

Kitamura, Kazuyoshi; Chiba, Tatsuya; Mabuchi, Fumihiko; Ishijima, Kiyotaka; Omoto, Shu; Kashiwagi, Fumiko; Godo, Takashi; Kogure, Satoshi; Goto, Teruhiko; Shibuya, Takashi; Tanabe, Jhoji; Tsukahara, Shigeo; Tsuchiya, Tadaharu; Tokunaga, Takaharu; Hosaka, Osamu; Saito, Tetsunori

2018-01-01

Purpose To assess the efficacy and safety of switching from prostaglandin analog (PGA) monotherapy to tafluprost/timolol fixed-combination (Taf/Tim) therapy. Subjects and Methods Patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who had received PGA monotherapy for at least 3 months were enrolled. Patients were examined at 1, 2, and 3 months after changing therapies. Subsequently, the patients were returned to PGA monotherapy. The examined parameters included intraocular pressure (IOP) and adverse events. A questionnaire survey was conducted after the switch to Taf/Tim therapy. Results Forty patients with a mean age of 66.5 ± 10.3 years were enrolled; 39 of these patients completed the study protocol. Switching to Taf/Tim significantly reduced the IOP from 18.2 ± 2.6 mmHg at baseline to 14.8 ± 2.5 mmHg at 1 month, 15.2 ± 2.8 mmHg at 2 months, and 14.9 ± 2.5 mmHg at 3 months (P Taf/Tim reduced the pulse rate insignificantly. No significant differences were observed in blood pressure, conjunctival hyperemia, or corneal adverse events. A questionnaire showed that the introduction of Taf/Tim did not significantly influence symptoms. Conclusions Compared with PGA monotherapy, Taf/Tim fixed-combination therapy significantly reduced IOP without severe adverse events. PMID:29675274

Progesterone increases resistance of ophthalmic and central retinal arteries in climacteric women.

Science.gov (United States)

Souza, M A M De; Souza, B M De; Geber, S

2013-04-01

To evaluate the effect of a synthetic progestin on the vascular resistance of the ophthalmic and central retinal arteries in climacteric women, compared to placebo, using transorbital ultrasound with Doppler velocimetry. We performed a prospective, randomized, double-blinded, placebo-controlled study with 216 climacteric women. Subjects were randomly allocated to one of two groups: either the group receiving placebo (one pill/day for 30 days) (n = 108) or the group receiving progestin (5 mg medroxyprogesterone acetate/day for 30 days) (n = 108). Transorbital Doppler velocimetric ultrasound was performed, before and after treatment; we measured the pulsatility index, resistance index and systole/diastole ratio. The mean ages of the participants in the study group and the control group were 54 ± 6.2 years (range 48-59 years) and 55 ± 6.8 years (range 46-60 years), respectively. When we compared the effect of the progestin on the central retinal artery before and after treatment, we observed a significant increase after the treatment in all Doppler indices. The same was observed when we compared the effect of the progestin on the ophthalmic artery. In the group of women receiving placebo, the Doppler indices were similar before and after treatment. Our results demonstrate the existence of a progestogenic vasoconstrictive effect in the ophthalmic and central retinal arteries. As this study provides new data, the observed effect needs further investigations to better elucidate its extent. Moreover, our findings may be particularly useful to others interested in understanding the vascular dynamics of the cerebral vessels and to researchers running clinical trials related to hormone replacement therapy.

21 CFR 524.1662b - Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic ointment.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Oxytetracycline hydrochloride, polymyxin B sulfate... DOSAGE FORM NEW ANIMAL DRUGS § 524.1662b Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic ointment. (a) Specifications. Each gram of the ointment contains oxytetracycline hydrochloride equivalent...

Validated spectrofluorimetric and spectrophotometric methods for the determination of brimonidine tartrate in ophthalmic solutions via derivatization with NBD-Cl. Application to stability study.

Science.gov (United States)

Ibrahim, F; El-Enany, N; El-Shaheny, R N; Mikhail, I E

2015-05-01

Two simple, selective and accurate methods were developed and validated for the determination of brimonidine tartrate (BT) in pure state and pharmaceutical formulations. Both methods are based on the coupling of the drug with 4-chloro-7-nitro-2,1,3-benzoxadiazole in borate buffer (pH 8.5) at 70 °C and measurement of the reaction product spectrophotometrically at 407 nm (method I) or spectrofluorimetrically at 528 nm upon excitation at 460 nm (method II). The calibration graphs were rectilinear over the concentration ranges of 1.0-16.0 and 0.1-4.0 µg/mL with lower detection limits of 0.21 and 0.03, and lower quantification limits of 0.65 and 0.09 µg/mL for methods I and II, respectively. Both methods were successfully applied to the analysis of commercial ophthalmic solution with mean recovery of 99.50 ± 1.00 and 100.13 ± 0.71%, respectively. Statistical analysis of the results obtained by the proposed methods revealed good agreement with those obtained using a comparison method. The proposed spectrofluorimetric method was extended to a stability study of BT under different ICH-outlined conditions such as alkaline, acidic, oxidative and photolytic degradation. Furthermore, the kinetics of oxidative degradation of the drug was investigated and the apparent first-order reaction rate constants, half-life times and Arrhenius equation were estimated. The proposed methods are practical and valuable for routine applications in quality control laboratories for the analysis of BT. Copyright © 2014 John Wiley & Sons, Ltd.

Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

Directory of Open Access Journals (Sweden)

Wirta D

2011-06-01

Full Text Available David Wirta1, Amanda M VanDenburgh2, Emily Weng3, Scott M Whitcup4, Sef Kurstjens5, Frederick C Beddingfield III4,61Private Practice, Newport Beach, CA, USA; 2Clinical Development, 3Biostatistics, 4Research and Development, 5Global Drug Development, Allergan, Inc, Irvine, CA, USA; 6Department of Medicine, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USABackground: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥ 12months were conducted; however, the aggregate safety profile of the six studies has not been reported.Methods: Adverse events (AEs were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD or twice daily (BID as an eyedrop. AE terms were converted to MedDRA (V.11.0 Preferred Terms and analyzed.Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD and 94.8% (BID of subjects (≤ 12 months of treatment. AEs reported through month 12 (aggregate incidence of ≥ 5% were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment.Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation.Keywords: intraocular pressure, eyelids, pharmacology, clinical trial, medical treatment

Laser tissue welding in ophthalmic surgery.

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Rossi, Francesca; Matteini, Paolo; Ratto, Fulvio; Menabuoni, Luca; Lenzetti, Ivo; Pini, Roberto

2008-09-01

Laser welding of ocular tissues is an alternative technique or adjunct to conventional suturing in ophthalmic surgery. It is based on the photothermal interaction of laser light with the main components of the extracellular matrix of connective tissues. The advantages of the welding procedure with respect to standard suturing and stapling are reduced operation times, lesser inflammation, faster healing and increased ability to induce tissue regeneration. The procedure we set up is based on the use of an infrared diode laser in association with the topical application of the chromophore Indocyanine Green. Laser light may be delivered either continuously or in pulses, thus identifying two different techniques that have been applied clinically in various types of transplants of the cornea.

Ophthalmic compensation of visual ametropia based on a programmable diffractive lens

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Millán, Maria S.; Pérez-Cabré, Elisabet; Romero, Lenny A.; Ramírez, Natalia

2013-11-01

Pixelated liquid crystal displays have been widely used as spatial light modulators to implement programmable diffractive optical elements (DOEs), particularly diffractive lenses. Many different applications of such components have been developed in information optics and optical processors that take advantage of their properties of great flexibility, easy and fast refreshment, and multiplexing capability in comparison with equivalent conventional refractive lenses. In this paper, we explore the application of programmable diffractive lenses displayed on the pixelated screen of a liquid crystal on silicon spatial light modulator (LCoS-SLM) to ophthalmic optics. In particular, we consider the use of programmable diffractive lenses for the visual compensation of some refractive errors (myopia, hyperopia). The theoretical principles of compensation are described and sketched using geometrical optics and paraxial ray tracing. A series of experiments with artificial eye in optical bench are conducted to analyze the compensation accuracy in terms of optical power and to compare the results with those obtained by means of conventional ophthalmic lenses. Practical considerations oriented to feasible applications are provided.

Endovascular Treatment of Persistent Epistaxis due to Pseudoaneurysm Formation of the Ophthalmic Artery Secondary to Nasogastric Tube

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Selcuk, Hakan, E-mail: hakanselcuk73@yahoo.com; Soylu, Nur; Albayram, Sait; Selcuk, Dogan; Ozer, Harun; Kocer, Naci; Islak, Civan [Cerrahpasa Medical School, Istanbul University, Department of Radiology, Division of Neuroradiology (Turkey)

2005-04-15

We present the case of a 60-year-old man with persistent epistaxis for 20 days that had started 2 weeks after removal of a nasogastric tube placed for an abdominal operation. There was no pathologic finding at selective facial and internal maxillary artery injections. An injury to the ethmoidal branches of the ophthalmic arteries or other arterial origins of bleeding was suspected. The internal carotid artery angiography revealed a pseudoaneurysm of an anterior ethmoidal branch of the left ophthalmic artery. The pseudoaneurysm was occluded with NBCA-histoacryl (25%) injection.

Endovascular Treatment of Persistent Epistaxis due to Pseudoaneurysm Formation of the Ophthalmic Artery Secondary to Nasogastric Tube

International Nuclear Information System (INIS)

Selcuk, Hakan; Soylu, Nur; Albayram, Sait; Selcuk, Dogan; Ozer, Harun; Kocer, Naci; Islak, Civan

2005-01-01

We present the case of a 60-year-old man with persistent epistaxis for 20 days that had started 2 weeks after removal of a nasogastric tube placed for an abdominal operation. There was no pathologic finding at selective facial and internal maxillary artery injections. An injury to the ethmoidal branches of the ophthalmic arteries or other arterial origins of bleeding was suspected. The internal carotid artery angiography revealed a pseudoaneurysm of an anterior ethmoidal branch of the left ophthalmic artery. The pseudoaneurysm was occluded with NBCA-histoacryl (25%) injection

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

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2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

Scientific publications in ophthalmic journals from China and other top-ranking countries: a 12-year review of the literature.

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Huang, Wenbin; Wang, Wei; Zhan, Jiao; Zhou, Minwen; Chen, Shida; Zhang, Xiulan

2013-06-26

Eye diseases with increasing mortality are common health problems that affect people of all ages and demographic backgrounds. In this study, we study the publication characteristics in international ophthalmic journals of the US, the UK, Germany, Australia, Japan, and China. Articles published in 53 ophthalmic journals from 2000 to 2011 were retrieved from the PubMed database. We recorded the number of articles published each year, analyzed the publication type, and evaluated the accumulated and average impact factors (IFs), and the distribution of articles in ophthalmic journals in relation to IFs. The characteristics of publication outputs from China and other top-ranking countries were compared. The total number of articles increased significantly during the past 12 years, with an increase of 51.0%. The growth in the annual number of articles from the US, the UK, Australia, and China showed a significantly positive trend. Publications from the US exceeded those from any other country and had the highest IFs, largest number of total citations of articles, and the most articles published in leading ophthalmic journals. During the past 12 years, China contributed 3.5% of the total publications, and the number of Chinese articles showed a more than 6-fold increase (from 99 to 605, R2 =0.947, P<0.001). The numbers of IFs and citations of articles originating in China were mostly lower than for other top-ranking counties. Research on ophthalmic journals has maintained an upward growing trend from 2000 to 2011. Chinese ophthalmology research has developed rapidly, but the gap still exists between China and other top-ranking countries for the advanced level of research.

Ocular pharmacokinetics and tolerability of bimatoprost ophthalmic solutions administered once or twice daily in rabbits, and clinical dosing implications

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Shen J

2017-09-01

Full Text Available Jie Shen,1 Margot L Goodkin,2 Warren Tong,2 Mayssa Attar3 1Clinical Pharmacology, 2Clinical Development, 3Clinical Pharmacology, Metabolism and Immunology, Allergan plc, Irvine, CA, USA Purpose: Fixed-combination medications can benefit patients requiring multiple agents to lower their intraocular pressure (IOP, but combining agents with complementary mechanisms of action is challenging if their dosing frequency differs. This study compares in vivo pharmacokinetic and ocular tolerability of bimatoprost 0.01% ophthalmic solutions dosed once or twice daily. Reports of twice-daily dosing in glaucoma patients are also reviewed.Methods: New Zealand White rabbits were administered bimatoprost 0.01% monotherapy or fixed-combination bimatoprost 0.01%/brimonidine 0.1%, once or twice daily in both eyes for 4 days. Ocular tissues were harvested and analyzed by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters calculated included maximum observed concentration, time to maximum concentration, and area under the concentration-time curve.Results: Due to extensive metabolism, bimatoprost concentration was below the quantitation limit by 1 hour post-dose in all samples. Bimatoprost acid exposure, however, could be measured up to 6–8 hours post-dose and was similar in the aqueous humor and iris-ciliary body (pharmacological site of action of animals treated once or twice daily with either bimatoprost 0.01% or fixed-combination bimatoprost 0.01%/brimonidine 0.1%. Increasing dosage frequency in rabbits did not raise the incidence of drug-related conjunctival hyperemia (most common adverse event associated with bimatoprost use in humans, suggesting comparable ocular tolerability of the once- and twice-daily regimens for each formulation.Conclusion: Bimatoprost 0.01% administered once or twice daily as monotherapy and in fixed-combination with brimonidine 0.1% in rabbits show similar pharmacokinetic profiles of bimatoprost acid

Sustained ophthalmic delivery of highly soluble drug using pH-triggered inner layer-embedded contact lens.

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Zhu, Qiang; Cheng, Hongbo; Huo, Yingnan; Mao, Shirui

2018-06-10

In the present work the feasibility of using inner layer-embedded contact lenses (CLs) to achieve sustained release of highly water soluble drug, betaxolol hydrochloride (BH) on the ocular surface was investigated. Blend film of cellulose acetate and Eudragit S100 was selected as the inner layer, while silicone hydrogel was used as outer layer to construct inner layer-embedded contact lenses. Influence of polymer ratio in the blend film on in vitro drug release behavior in phosphate buffered solution or simulated tear fluid was studied and drug-polymer interaction, erosion and swelling of the blend film were characterized to better understand drug-release mechanism. Storage stability of the inner layer-embedded contact lenses in phosphate buffer solution was also conducted, with ignorable drug loss and negligible change in drug release pattern within 30 days. In vivo pharmacokinetic study in rabbits showed sustained drug release for over 240 h in tear fluid, indicating prolonged drug precorneal residence time. In conclusion, cellulose acetate/Eudragit S100 inner layer-embedded contact lenses are quite promising as controlled-release carrier of highly water soluble drug for ophthalmic delivery. Copyright © 2018 Elsevier B.V. All rights reserved.

Formulation and process factors influencing product quality and in vitro performance of ophthalmic ointments.

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Xu, Xiaoming; Al-Ghabeish, Manar; Rahman, Ziyaur; Krishnaiah, Yellela S R; Yerlikaya, Firat; Yang, Yang; Manda, Prashanth; Hunt, Robert L; Khan, Mansoor A

2015-09-30

Owing to its unique anatomical and physiological functions, ocular surface presents special challenges for both design and performance evaluation of the ophthalmic ointment drug products formulated with a variety of bases. The current investigation was carried out to understand and identify the appropriate in vitro methods suitable for quality and performance evaluation of ophthalmic ointment, and to study the effect of formulation and process variables on its critical quality attributes (CQA). The evaluated critical formulation variables include API initial size, drug percentage, and mineral oil percentage while the critical process parameters include mixing rate, temperature, time and cooling rate. The investigated quality and performance attributes include drug assay, content uniformity, API particle size in ointment, rheological characteristics, in vitro drug release and in vitro transcorneal drug permeation. Using design of experiments (DoE) as well as a novel principle component analysis approach, five of the quality and performance attributes (API particle size, storage modulus of ointment, high shear viscosity of ointment, in vitro drug release constant and in vitro transcorneal drug permeation rate constant) were found to be highly influenced by the formulation, in particular the strength of API, and to a lesser degree by processing variables. Correlating the ocular physiology with the physicochemical characteristics of acyclovir ophthalmic ointment suggested that in vitro quality metrics could be a valuable predictor of its in vivo performance. Published by Elsevier B.V.

Application of ophthalmic ultrasonographyin DR

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Ya-Ke Li

2018-02-01

Full Text Available AIM: To investigate the value of ultrasonography in diabetic retinopathy(DR. METHODS: Totally 103 cases(103 eyesof type 2 diabetes mellitus were selected from May 2015 to May 2017 in our hospital, there were 32 patients 32 eyes with non diabetic retinopathy(NDR, 40 patients 40 eyes with non proliferative diabetic retinopathy(NPDR, and 31 patients 31 eyes with proliferative diabetic retinopathy(PDR, 40 healthy volunteers(40 eyeswere selected as control group, the maximum systolic blood flow velocity(PSV, end diastolic velocity(EDVand resistance index(RIof the central retinal artery(CRA, posterior ciliary artery(PCAand ophthalmic artery(OAwere detected by color Doppler ultrasound. RESULTS: The difference of PSV, EDV and RI of CRA, PCA and OA in each group was statistically significant(PPPPCONCLUSION: Color Doppler ultrasound monitoring the hemodynamic changes of ocular blood vessels in diabetes can provide evidence for early detection of diabetic retinopathy.

Neuro-ophthalmic and clinical characteristics of brain tumours in a tertiary hospital in Ghana

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Tagoe, N. N.; Essuman, V. A.; Fordjuor, G.; Akpalu, J.; Bankah, P.; Ndanu, T.

2015-01-01

Anecdotally, increasing number of patients are seen at Korle Bu Teaching Hospital (KBTH) with brain tumour. Neuro-ophthalmic symptoms and signs may help in timely diagnosis and intervention. The objective of this study is to evaluate the neuro-ophthalmic and clinical characteristics of brain tumour in patients presenting at a tertiary hospital in Ghana. The study design involved a prospective case series involving 36 consecutive patients newly diagnosed with brain tumour from November 2010 to October 2011, at the Ophthalmology, Neurosurgery and Endocrine units of KBTH, Ghana. All patients had clinical diagnosis of brain tumour with confirmation by computerized tomography (CT) or magnetic resonance imaging (MRI). Thirteen patients had histological confirmation of diagnosis. The outcome measures of the study include presenting visual acuity, colour vision, visual fields and cranial nerve deficits. Data of 36 patients were analysed. The results of the study showed that ages ranged from 3 to 69 years, mean (SD) 42.56(±16.6 years). Twenty-six (72%) were females. Tumours included pituitary adenoma (20, 55.5%), meningioma (10, 27.8%), choroid plexus tumour (1, 2.8%), medulloblastom (1, 2.8%), craniopharyngioma (1, 2.8%), haemangioblastoma (1, 2.8%), thalamic tumour (1, 2.8%) and haemangioma (1, 2.8%). Histologically confirmed tumours included pituitary adenoma (9, 69.2%), meningioma (3, 23.1%), craniopharyngioma (1, 7.7%). One patient had both a pituitary adenoma and meningioma. Blurred vision (30, 83.3%), headache (28, 77.8%) and photophobia (13, 36.1%) were predominant symptoms. Commonest neuro-ophthalmic signs were impaired colour vision (62 eyes, 88.6%), optic atrophy (26, 74.3%), unilateral or bitemporal hemianopia (15, 41.5%) and relative afferent pupillary defect (12, 34.3%). Seven (19.4%) patients were visually impaired and nine (25%) blind. Thirty-three of 72(45.8%) eyes had monocular blindness. Common neuro-ophthalmic characteristics were blurred vision

Correlation of ophthalmic examination with carrier status in females potentially harboring a severe Norrie disease gene mutation.

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Khan, Arif O; Aldahmesh, Mohammed A; Meyer, Brian

2008-04-01

To correlate ophthalmic findings with carrier status for a severe Norrie disease (ND) gene mutation (C95F). Prospective interventional case series. Six potential carriers and 1 obligate carrier from a family harboring the mutation. An ophthalmologist blind to the pedigree performed a full ophthalmic examination for the 7 asymptomatic family members. A peripheral blood sample was collected from each for ND gene sequencing. Ophthalmic examination findings (with attention to the presence or absence of retinal findings) and results of ND gene sequencing. Three carriers were identified by molecular genetics, and all 3 of them had peripheral retinal abnormality. However, 3 of the 4 genetically identified noncarriers also exhibited peripheral retinal abnormality. Two of these noncarriers with retinal findings were the offspring of a confirmed noncarrier. The genetically identified noncarrier with a normal peripheral retinal examination was the daughter of an obligate carrier. The presence of peripheral retinal changes was not useful for carrier prediction in a family harboring ND. There are likely additional loci responsible for phenotypic expression.

Comparison between bimatoprost and latanoprost-timolol fixed combination for efficacy and safety after switching patients from latanoprost.

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Maruyama, Yuko; Ikeda, Yoko; Mori, Kazuhiko; Ueno, Morio; Yoshikawa, Haruna; Kinoshita, Shigeru

2015-01-01

The purpose of this study was to prospectively evaluate and compare intraocular pressure (IOP) reduction efficacy and safety between bimatoprost and latanoprost-timolol fixed combination (LTFC) in Japanese patients with open-angle glaucoma. In this prospective, randomized, non-masked study, after enrolling 70 eyes of 70 Japanese open-angle glaucoma patients who had used latanoprost monotherapy for more than 4 weeks, the subjects were randomly divided into a bimatoprost group or an LTFC group. Both groups were switched from latanoprost to bimatoprost or LTFC for 12 weeks. IOP, conjunctival injection score, corneal epitheliopathy score (area density classification; AD score), tear film break-up time, heart rate, and blood pressure were evaluated at 0, 4, and 12 weeks after switching. The paired t-test and Mann-Whitney U-test were used for the statistical analysis. After 13 of the 70 patients dropped out, 57 were analyzed for IOP reduction and safety. There was a significant decrease in mean IOP at 4 weeks compared with week 0 in both groups (both Pbreak-up time, heart rate, and blood pressure. Bimatoprost and LTFC exhibited similar efficacy for reduction of IOP. Safety results indicated that only the conjunctival injection score at 12 weeks was higher in the bimatoprost group compared with the LTFC group.

Ophthalmic acid accumulation in an Escherichia coli mutant lacking the conserved pyridoxal 5'-phosphate-binding protein YggS.

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Ito, Tomokazu; Yamauchi, Ayako; Hemmi, Hisashi; Yoshimura, Tohru

2016-12-01

Escherichia coli YggS is a highly conserved pyridoxal 5'-phosphate (PLP)-binding protein whose biochemical function is currently unknown. A previous study with a yggS-deficient E. coli strain (ΔyggS) demonstrated that YggS controls l-Ile- and l-Val-metabolism by modulating 2-ketobutyrate (2-KB), l-2-aminobutyrate (l-2-AB), and/or coenzyme A (CoA) availability in a PLP-dependent fashion. In this study, we found that ΔyggS accumulates an unknown metabolite as judged by amino acid analyses. LC/MS and MS/MS analyses of the compound with propyl chloroformate derivatization, and co-chromatography analysis identified this compound as γ-l-glutamyl-l-2-aminobutyryl-glycine (ophthalmic acid), a glutathione (GSH) analogue in which the l-Cys moiety is replaced by l-2-AB. We also determine the metabolic consequence of the yggS mutation. Absence of YggS initially increases l-2-AB availability, and then causes ophthalmic acid accumulation and CoA limitation in the cell. The expression of a γ-glutamylcysteine synthetase and a glutathione synthetase in a ΔyggS background causes high-level accumulation of ophthalmic acid in the cells (∼1.2 nmol/mg cells) in a minimal synthetic medium. This opens the possibility of a first fermentative production of ophthalmic acid. Copyright © 2016 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

Development and characterisation of electrospun timolol maleate-loaded polymeric contact lens coatings containing various permeation enhancers.

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Mehta, Prina; Al-Kinani, Ali A; Arshad, Muhammad Sohail; Chang, Ming-Wei; Alany, Raid G; Ahmad, Zeeshan

2017-10-30

Despite exponential growth in research relating to sustained and controlled ocular drug delivery, anatomical and chemical barriers of the eye still pose formulation challenges. Nanotechnology integration into the pharmaceutical industry has aided efforts in potential ocular drug device development. Here, the integration and in vitro effect of four different permeation enhancers (PEs) on the release of anti-glaucoma drug timolol maleate (TM) from polymeric nanofiber formulations is explored. Electrohydrodynamic (EHD) engineering, more specifically electrospinning, was used to engineer nanofibers (NFs) which coated the exterior of contact lenses. Parameters used for engineering included flow rates ranging from 8 to 15μL/min and a novel EHD deposition system was used; capable of hosting four lenses, masked template and a ground electrode to direct charged atomised structures. SEM analysis of the electrospun structures confirmed the presence of smooth nano-fibers; whilst thermal analysis confirmed the stability of all formulations. In vitro release studies demonstrated a triphasic release; initial burst release with two subsequent sustained release phases with most of the drug being released after 24h (86.7%) Biological evaluation studies confirmed the tolerability of all formulations tested with release kinetics modelling results showing drug release was via quasi-Fickian or Fickian diffusion. There were evident differences (p<0.05) in TM release dependant on permeation enhancer. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Protective Effect of Tea Polyphenol Ophthalmic Gel on Lens Epithelial Cells in Rabbits with Silicone Oil Tamponade after Vitrectomy

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Xianzhen Ma

2014-01-01

Full Text Available Purpose. The aim of this study was to investigate the effect of tea polyphenols (TP ophthalmic gel on lens epithelial cells (LECs in rabbits with silicone oil tamponade after vitrectomy. Methods. In this study, unilateral vitrectomy with silicone oil tamponade was performed using 2-month-old New Zealand white rabbits (n = 72; meanwhile, age-matched nonoperated rabbits (n = 18 were used as controls. The TP ophthalmic gel was administered topically in the surgical eyes till they were sacrificed. On days 45 and 90 after operation, the levels of reactive oxygen species (ROS, mitochondrial membrane potential (ΔΨm, and apoptosis of LECs were analyzed, respectively. Meanwhile, caspase-3 mRNA and protein levels were also determined. Results. The results indicate that the levels of ROS and apoptosis were elevated for LECs in rabbits after operation, whereas ΔΨm was decreased. Caspase-3 was apparently increased at both mRNA and protein levels. Treatment of TP ophthalmic gel could reduce the generation of ROS, maintain ΔΨm, inhibit the overexpression of caspase-3, and thus decrease the apoptosis of LECs of rabbits after operation. Conclusions. TP ophthalmic gel can efficiently inhibit caspase-3 overexpression, reduce the apoptosis of LECs, and prevent LECs from damage. Our result provides a new approach to prevent the development of complicated cataract after vitrectomy.

Numerical Modeling of Ophthalmic Response to Space

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Nelson, E. S.; Myers, J. G.; Mulugeta, L.; Vera, J.; Raykin, J.; Feola, A.; Gleason, R.; Samuels, B.; Ethier, C. R.

2015-01-01

To investigate ophthalmic changes in spaceflight, we would like to predict the impact of blood dysregulation and elevated intracranial pressure (ICP) on Intraocular Pressure (IOP). Unlike other physiological systems, there are very few lumped parameter models of the eye. The eye model described here is novel in its inclusion of the human choroid and retrobulbar subarachnoid space (rSAS), which are key elements in investigating the impact of increased ICP and ocular blood volume. Some ingenuity was required in modeling the blood and rSAS compartments due to the lack of quantitative data on essential hydrodynamic quantities, such as net choroidal volume and blood flowrate, inlet and exit pressures, and material properties, such as compliances between compartments.

Regulation of vascular tone in rabbit ophthalmic artery: cross talk of endogenous and exogenous gas mediators.

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Salomone, Salvatore; Foresti, Roberta; Villari, Ambra; Giurdanella, Giovanni; Drago, Filippo; Bucolo, Claudio

2014-12-15

Nitric oxide (NO), carbon monoxide (CO) and hydrogen sulphide (H2S) modulate vascular tone. In view of their therapeutic potential for ocular diseases, we examined the effect of exogenous CO and H2S on tone of isolated rabbit ophthalmic artery and their interaction with endogenous and exogenous NO. Ophthalmic artery segments mounted on a wire myograph were challenged with cumulative concentrations of phenylephrine (PE) in the presence or absence of NG-nitro-L-arginine (LNNA) to inhibit production of NO, the CO-releasing molecules CORMs or the H2S-donor GYY4137. The maximal vasoconstriction elicited by PE reached 20-30% of that induced by KCl but was dramatically increased by incubation with LNNA. GYY4137 significantly raised PE-mediated vasoconstriction, but it did not change the response to PE in the presence of LNNA or the relaxation to sodium nitroprusside (SNP). CORMs concentration-dependently inhibited PE-induced constriction, an effect that was synergistic with endogenous NO (reduced by LNNA), but insensitive to blockade of guanylyl cyclase by 1H-[1,2,4]oxadiazolo[4,3,-α]quinoxalin-1-one (ODQ). In vascular tissues cyclic GMP (cGMP) levels seemed reduced by GYY4137 (not significantly), but were not changed by CORM. These data indicate that CO is able per se to relax isolated ophthalmic artery and to synergize with NO, while H2S counteracts the effect of endogenous NO. CO does not stimulate cGMP production in our system, while H2S may reduce cGMP production stimulated by endogenous NO. These findings provide new insights into the complexities of gas interactions in the control of ophthalmic vascular tone, highlighting potential pharmacological targets for ocular diseases. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of incisional friction and ophthalmic viscosurgical devices on the heat generation of ultrasound during cataract surgery.

Science.gov (United States)

Floyd, Michael; Valentine, Jeremy; Coombs, Jamie; Olson, Randall J

2006-07-01

To determine the thermal features of the Legacy (Alcon) and Sovereign (Advanced Medical Optics) phacoemulsification machines in a cadaver eye and with 7 ophthalmic viscosurgical devices (OVDs). In situ and in vitro study. Temperature without occlusion was recorded at the sleeve placed in the wound of a cadaver eye, and temperature over baseline was determined after 60 seconds. The result was then compared with the results in a previous study that used balanced salt solution (BSS) in artificial chambers. In the second portion of the experiment, with irrigation and aspiration lines occluded, temperature was recorded at the sleeve placed in an artificial chamber filled with sodium hyaluronate 2.3% (Healon5), sodium hyaluronate 1.4% (Healon GV), sodium hyaluronate 1.0% (Healon), sodium hyaluronate 1.6% (Amvisc Plus), sodium hyaluronate 1.0% (Provisc), sodium hyaluronate 3.0%-chondroitin sulfate 4.0% (Viscoat), or hyaluronate 3.0% (Vitrax). Temperature over baseline was also determined after 60 seconds. These results were compared with each set of OVD data and with the results in the prior BSS study. In the eye-bank model, the Legacy machine had a 62% temperature increase from incisional friction and the Sovereign machine had a decrease of 8.6% over results in an artificial anterior chamber. The OVD temperature increases were greater for the Sovereign (Pgeneration in the Legacy, a stroke-length driven instrument, more than in the Sovereign, a power-driven instrument. Ophthalmic viscosurgical devices are not only a concern due to outflow occlusion but can also add up to 6 times the heat in comparison with BSS. The need to aspirate the OVD before using ultrasound is thus verified.

Thermosetting gels with modulated gelation temperature for ophthalmic use: the rheological and gamma scintigraphic studies.

Science.gov (United States)

Wei, Gang; Xu, Hui; Ding, Ping Tian; Li, San Ming; Zheng, Jun Min

2002-09-18

For ophthalmic drug delivery, Pluronic F127 solutions have a phase transition temperature too low for them to be instilled into the eye at room temperature. Refrigerator storage is usually required to make administration easier, whereas the potential irritation of cold to the sensitive ocular tissues may result in poor topical bioavailability. The purpose of this study is to develop a thermosetting gel with a suitable phase transition temperature by combining Pluronic analogs and to examine the influence of incorporating mucoadhesive polysaccharide, sodium hyaluronate (HA-Na), on the ocular retention of the gel. Dynamic rheological method and single photon emission computing tomography (SPECT) technique were used to ex/in vivo evaluate the thermosetting gels, respectively. An optimized formulation containing 21% F127 and 10% F68 increased the phase transition temperature by 9 degrees C as evaluated by elasticity modulus compared to that of individual 21% F127 solution. Rheological behaviors of the Pluronic solutions showed that the combined Pluronic formulation was free flowing liquid below 25 degrees C and converted to a firm gel under the physiological condition. Furthermore, this formulation possessed the highest viscosity both before and after tear dilution at 35 degrees C. Gamma scintigraphic data demonstrated that the clearance of the thermosetting gel labeled with 99mTc-DTPA was significantly delayed with respect to the phosphate buffered solution, and at least a threefold increase of the corneal residence time was achieved. However, no further improvement in the ocular retention was observed when adding HA-Na into the thermosetting gel due to the substantially decreased gel strength. Copyright 2002 Elsevier Science B.V.

Multimodal ophthalmic imaging using handheld spectrally encoded coherence tomography and reflectometry (SECTR)

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Leeburg, Kelsey C.; El-Haddad, Mohamed T.; Malone, Joseph D.; Terrones, Benjamin D.; Tao, Yuankai K.

2018-02-01

Scanning laser ophthalmoscopy (SLO) provides high-speed, noninvasive en face imaging of the retinal fundus. Optical coherence tomography (OCT) is the current "gold-standard" for ophthalmic diagnostic imaging and enables depth-resolved visualization of ophthalmic structures and image-based surrogate biomarkers of disease. We present a compact optical and mechanical design for handheld spectrally encoded coherence tomography and reflectometry (SECTR) for multimodality en face spectrally encoded reflectometry (SER) and cross-sectional OCT imaging. We custom-designed a double-pass telecentric scan lens, which halves the size of 4-f optical relays and allowed us to reduce the footprint of our SECTR scan-head by a factor of >2.7x (volume) over our previous design. The double-pass scan lens was optimized for diffraction-limited performance over a +/-10° scan field. SECTR optics and optomechanics were combined in a compact rapid-prototyped enclosure with dimensions 87 x 141.8 x 137 mm (w x h x d). SECTR was implemented using a custom-built 400 kHz 1050 nm swept-source. OCT and SER were simultaneously digitized on dual input channels of a 4 GS/s digitizer at 1.4 GS/s per channel. In vivo human en face SER and cross-sectional OCT images were acquired at 350 fps. OCT volumes of 1000 B-scans were acquired in 2.86 s. We believe clinical translation of our compact handheld design will benefit point-of-care ophthalmic diagnostics in patients who are unable to be imaged on conventional slit-lamp based systems, such as infants and the bedridden. When combined with multi-volumetric registration methods, handheld SECTR will have advantages in motion-artifact free imaging over existing handheld technologies.

Dosimetry of Sr-90 ophthalmic applicators

International Nuclear Information System (INIS)

Reft, C.S.; Kuchnir, F.T.; Rosenberg, I.; Myrianthopoulos, L.C.

1990-01-01

Sr-90 ophthalmic applicators are commonly used for the treatment of superficial eye disorders. Although a variety of dosimetric devices such as film, thermoluminescent dosimeters (TLD's), ion chambers, and radiochromic foils have been used to measure the peak dose at the applicator surface, there is no internationally agreed upon calibration procedure. Recently, large discrepancies among calibrations of the same applicator at three institutions have been reported. Here we describe a technique to obtain the peak dose rate at the applicator surface using LiF TLD's. The technique can be used for the calibration of flat as well as curved surface applicators. Results for two flat and three concave applicators are presented. Our measurement of the surface dose rate for one of the flat applicators is compared with those obtained by four other institutions, each using different dosimetric devices

Efficacy and safety of travoprost 0.004%/timolol 0.5% fixed combination as transition therapy in patients previously on prostaglandin analog monotherapy

Directory of Open Access Journals (Sweden)

Costa VP

2012-05-01

Full Text Available Vital Paulino Costa1, Hamilton Moreira2, Mauricio Della Paolera3, Maria Rosa Bet de Moraes Silva41Universidade Estadual de Campinas – UNICAMP, São Paulo, 2Universidade Federal do Paraná, Curitiba, 3Santa Casa de Misericórdia de São Paulo, São Paulo, 4Faculdade de Medicina de Botucatu, UNESP, BrazilPurpose: To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP had been insufficiently controlled on prostaglandin analog (PGA monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC.Methods: This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to once-daily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12.Results: Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost. In the total population, mean IOP was significantly reduced from baseline (P = 0.000009, showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001 in the prior travoprost cohort (19.0% reduction and in the prior nontravoprost cohort (13.1% reduction. Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular

Apraclonidine versus brinzolamide-timolol combination to prevent intraocular pressure elevation after laser capsulotomy

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Erkan Çelik

2016-01-01

Full Text Available AIM: To compare the efficacy of fixed combination of brinzolamide 1% and timolol 0.5%(FCBTwith apraclonidine 0.5%(APRAin preventing intraocular pressure(IOPelevations after neodymium: yttrium-aluminum-garnet(Nd:YAGlaser posterior capsulotomy.METHODS: This prospective randomized clinical study included 90 eyes of 90 consecutive patients who had Nd:YAG laser posterior capsulotomy for posterior capsule opacification(PCO. Patients were randomized to receive APRA(n=45or FCBT(n=45at 1h before laser surgery. A masked observer measured IOP by Goldmann applanation tonometry before the procedure and at 1, 2, 3, 24h and 7d after laser treatment. IOP outcome measures were grouped into the following categories: post laser IOP elevation of 5 to RESULTS:The mean IOP before surgery on the day of the procedure was 14.1±2.1 mm Hg in the APRA group and 13.2±2.1 mm Hg in the FCBT group. There was no statistically significant difference between the APRA and the FCBT groups of baseline IOPs measured(P=0.066. During the follow-up time, the mean IOP was lower in FCBT group, but this was not statistically significant. Six patients(13.3%in APRA group and 4(8.9%in FCBT group had IOP elevations of 5 to P=0.243. IOP elevations of 10 mm Hg or more occurred in 3 eyes(6.7%in the APRA group and 1 eyes(2.2%in the FCBT group; this was not statistically significant(P=0.542. CONCLUSION:Both of APRA and FCBT are effective for prevention and APRA is enough for most of routine cases. FCBT may be an option for the eyes those need more IOP reduction such as pre-existing glaucoma patients who are at higher risk for postoperative IOP elevations.

An historical ophthalmic study of Jane Austen.

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Wilson, Graham A

2012-11-01

Today, no other classic novelist has the popularity or power of Jane Austen, and in 2013 the world will celebrate 200 years of her comic masterpiece Pride and Prejudice. Her millions of fans have an abiding fascination with all aspects of her life, including her health and the cause of her death. This historical ophthalmic study of Jane Austen, based on very incomplete medical bibliographic data, finds that she had a mild ocular surface disorder from age 23. This disorder did not significantly impact on her visual performance for writing. There are many references to eyes in her novels, but Jane's eyes and those of her characters cannot contribute further to the debate around the cause of her death at age 41.

The effect of ketamine on the separation anxiety and emergence agitation in children undergoing brief ophthalmic surgery under desflurane general anesthesia

OpenAIRE

Jeong, Won Ju; Kim, Woon Young; Moon, Man Gook; Min, Doo Jae; Lee, Yoon Sook; Kim, Jae Hwan; Park, Young Cheol

2012-01-01

Background Emergence agitation (EA) frequently occurs after desflurane anesthesia in children. Ketamine, because of its sedative and analgesic properties, might be useful for the management of separation anxiety and EA. We investigated the preventive effect of ketamine on separation anxiety and EA after desflurane anesthesia in children for brief ophthalmic surgery. Methods Sixty children, ranging in age from 2-8 years old, undergoing brief ophthalmic surgery were randomly allocated to one of...

CHECKPOINT INHIBITOR IMMUNE THERAPY: Systemic Indications and Ophthalmic Side Effects.

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Dalvin, Lauren A; Shields, Carol L; Orloff, Marlana; Sato, Takami; Shields, Jerry A

2018-06-01

To review immune checkpoint inhibitor indications and ophthalmic side effects. A literature review was performed using a PubMed search for publications between 1990 and 2017. Immune checkpoint inhibitors are designed to treat system malignancies by targeting one of three ligands, leading to T-cell activation for attack against malignant cells. These ligands (and targeted drug) include cytotoxic T-lymphocyte antigen-4 (CTLA-4, ipilimumab), programmed death protein 1 (PD-1, pembrolizumab, nivolumab), and programmed death ligand-1 (PD-L1, atezolizumab, avelumab, durvalumab). These medications upregulate the immune system and cause autoimmune-like side effects. Ophthalmic side effects most frequently manifest as uveitis (1%) and dry eye (1-24%). Other side effects include myasthenia gravis (n = 19 reports), inflammatory orbitopathy (n = 11), keratitis (n = 3), cranial nerve palsy (n = 3), optic neuropathy (n = 2), serous retinal detachment (n = 2), extraocular muscle myopathy (n = 1), atypical chorioretinal lesions (n = 1), immune retinopathy (n = 1), and neuroretinitis (n = 1). Most inflammatory side effects are managed with topical or periocular corticosteroids, but advanced cases require systemic corticosteroids and cessation of checkpoint inhibitor therapy. Checkpoint inhibitors enhance the immune system by releasing inhibition on T cells, with risk of autoimmune-like side effects. Ophthalmologists should include immune-related adverse events in their differential when examining cancer patients with new ocular symptoms.

Efficacy of ophthalmic solutions to detach adhering Pseudomonas aeruginosa from contact lenses

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Landa, AS; van der Mei, HC; van Rij, G; Busscher, HJ

Purpose. To compare the efficacies of two all-in-one contact lens (CL) cleaning solutions and a detergent mixture on the detachment of a pathogenic bacterium adhering to two types of contact lenses in the absence and presence of a tear film. Methods. Bacterial-detachment studies were carried out in

Glaucoma Drug Therapy in Pregnancy: Literature Review and Teratology Information Service (TIS) Case Series.

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Pellegrino, Marcella; D'Oria, Luisa; De Luca, Carmen; Chiaradia, Giacomina; Licameli, Angelo; Neri, Caterina; Nucci, Marta; Visconti, Daniela; Caruso, Alessandro; De Santis, Marco

2018-01-01

There are many contradictions about pregnancy and fetal/neonatal outcomes after topical use of timolol alone or timolol in combination with other antiglaucoma medications. Seventy-five pregnant women exposed to antiglaucoma medications were followed prospectively by phone interviews. 27 women used timolol as monotherapy, 48 women used timolol as a part of multidrug therapy. We selected a control group of 187 healthy pregnant women. Topical use of timolol alone or timolol in combination with other antiglaucoma medications does not influence pregnancy or fetal/neonatal outcomes. Beta-blocker is the first choice treatment for glaucoma in pregnancy but, when necessary, multidrug therapy should not to be excluded. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Gasserian Ganglion and Retrobulbar Nerve Block in the Treatment of Ophthalmic Postherpetic Neuralgia: A Case Report.

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Huang, Jie; Ni, Zhongge; Finch, Philip

2017-09-01

Varicella zoster virus reactivation can cause permanent histological changes in the central and peripheral nervous system. Neural inflammatory changes or damage to the dorsal root ganglia sensory nerve fibers during reactivation can lead to postherpetic neuralgia (PHN). For PHN of the first division of the fifth cranial nerve (ophthalmic division of the trigeminal ganglion), there is evidence of inflammatory change in the ganglion and adjacent ocular neural structures. First division trigeminal nerve PHN can prove to be difficult and sometimes even impossible to manage despite the use of a wide range of conservative measures, including anticonvulsant and antidepressant medication. Steroids have been shown to play an important role by suppressing neural inflammatory processes. We therefore chose the trigeminal ganglion as an interventional target for an 88-year-old woman with severe ophthalmic division PHN after she failed to respond to conservative treatment. Under fluoroscopic guidance, a trigeminal ganglion nerve block was performed with lidocaine combined with dexamethasone. A retrobulbar block with lidocaine and triamcinolone settled residual oculodynia. At 1-year follow-up, the patient remained pain free and did not require analgesic medication. To our knowledge, this is the first reported case of ophthalmic division PHN successfully treated with a combination of trigeminal ganglion and retrobulbar nerve block using a local anesthetic agent and steroid for central and peripheral neural inflammatory processes. © 2016 World Institute of Pain.

Effectiveness and relevant factors of 2% rebamipide ophthalmic suspension treatment in dry eye.

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Ueda, Kaori; Matsumiya, Wataru; Otsuka, Keiko; Maeda, Yoshifumi; Nagai, Takayuki; Nakamura, Makoto

2015-06-06

Rebamipide with mucin secretagogue activity was recently approved for the treatment of dry eye. The efficacy and safety in the treatment of rebamipide were shown in two pivotal clinical trials. It was the aim of this study to evaluate the effect of 2% rebamipide ophthalmic suspension in patients with dry eye and analyze relevant factors for favorable effects of rebamipide in clinical practice. This was a retrospective cohort study of 48 eyes from 24 patients with dry eye treated with 2% rebamipide ophthalmic suspension. Dry eye-related symptom score, tear film break-up time (TBUT), fluorescein ocular surface staining score (FOS) and the Schirmer test were used to collect the data from patients at baseline, and at 2, 4, 8, and 12 week visits. To determine the relevant factors, multiple regression analyses were then performed. Mean dry eye-related symptom score showed a significant improvement from the baseline (14.5 points) at 2, 4, 8 and 12 weeks (9.80, 7.04, 7.04 and 7.83 points, corrected P value treatment. For ocular symptoms, three parameters (foreign body sensation, dry eye sensation and ocular discomfort) showed significant improvements at all visits. The multiple regression analyses showed that the fluorescein conjunctiva staining score was significantly correlated with the changes of dry eye-related symptom score at 12 weeks (P value = 0.017) and dry eye-related symptom score was significantly correlated with independent variables for the changes of FOS at 12 weeks (P value = 0.0097). Two percent rebamipide ophthalmic suspension was an effective therapy for dry eye patients. Moreover the fluorescein conjunctiva staining score and dry eye-related symptom score might be good relevant factors for favorable effects of rebamipide.

Human eye analytical and mesh-geometry models for ophthalmic dosimetry using MCNP6

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Angelocci, Lucas V.; Fonseca, Gabriel P.; Yoriyaz, Helio

2015-01-01

Eye tumors can be treated with brachytherapy using Co-60 plaques, I-125 seeds, among others materials. The human eye has regions particularly vulnerable to ionizing radiation (e.g. crystalline) and dosimetry for this region must be taken carefully. A mathematical model was proposed in the past [1] for the eye anatomy to be used in Monte Carlo simulations to account for dose distribution in ophthalmic brachytherapy. The model includes the description for internal structures of the eye that were not treated in previous works. The aim of this present work was to develop a new eye model based on the Mesh geometries of the MCNP6 code. The methodology utilized the ABAQUS/CAE (Simulia 3DS) software to build the Mesh geometry. For this work, an ophthalmic applicator containing up to 24 model Amersham 6711 I-125 seeds (Oncoseed) was used, positioned in contact with a generic tumor defined analytically inside the eye. The absorbed dose in eye structures like cornea, sclera, choroid, retina, vitreous body, lens, optical nerve and optical nerve wall were calculated using both models: analytical and MESH. (author)

Human eye analytical and mesh-geometry models for ophthalmic dosimetry using MCNP6

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Angelocci, Lucas V.; Fonseca, Gabriel P.; Yoriyaz, Helio, E-mail: hyoriyaz@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

2015-07-01

Eye tumors can be treated with brachytherapy using Co-60 plaques, I-125 seeds, among others materials. The human eye has regions particularly vulnerable to ionizing radiation (e.g. crystalline) and dosimetry for this region must be taken carefully. A mathematical model was proposed in the past [1] for the eye anatomy to be used in Monte Carlo simulations to account for dose distribution in ophthalmic brachytherapy. The model includes the description for internal structures of the eye that were not treated in previous works. The aim of this present work was to develop a new eye model based on the Mesh geometries of the MCNP6 code. The methodology utilized the ABAQUS/CAE (Simulia 3DS) software to build the Mesh geometry. For this work, an ophthalmic applicator containing up to 24 model Amersham 6711 I-125 seeds (Oncoseed) was used, positioned in contact with a generic tumor defined analytically inside the eye. The absorbed dose in eye structures like cornea, sclera, choroid, retina, vitreous body, lens, optical nerve and optical nerve wall were calculated using both models: analytical and MESH. (author)

A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

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Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

2015-03-01

To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

A cost-effectiveness analysis of fixed-combination therapies in patients with open-angle glaucoma: a European perspective.

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Hommer, A; Wickstrøm, J; Friis, M M; Steeds, C; Thygesen, J; Ferreras, A; Gouws, P; Buchholz, P

2008-04-01

To compare the efficacy and cost implications of the use of the intraocular pressure-lowering prostaglandin analogues bimatoprost, travoprost, and latanoprost as fixed-combination therapies with timolol, a beta-adrenergic receptor antagonist. A decision analytic cost-effectiveness model was constructed. Since no head-to-head studies comparing the three treatment options exist, the analysis was based on an indirect comparison. Hence, the model was based on efficacy data from five randomized, controlled, clinical studies. The studies were comparable with respect to study design, time horizon, patient population and type of end point presented. The measure of effectiveness was the percentage reduction of the intraocular pressure level from baseline. The cost evaluated was the cost of medication and clinical visits to the ophthalmologist. All drug costs were market prices inclusive of value-added tax, and visit costs were priced using official physician fees. Cost-effectiveness analyses were carried out in five European countries: Spain, Italy, United Kingdom, Norway and Sweden. The time horizon for the analyses was 3 months. The analysis showed that fixed-combination bimatoprost/timolol was more effective and less costly than fixed-combination travoprost/timolol and fixed-combination latanoprost/timolol in three out of the five countries analyzed. In two countries, bimatoprost/timolol was less costly than latanoprost/timolol, and cost the same as travoprost/timolol. This cost-effectiveness analysis showed that the fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was a cost-effective treatment option for patients with primary open-angle glaucoma. This study was limited by available clinical data: without a head-to-head trial, indirect comparisons were necessary. In the United Kingdom, Sweden, Norway, Italy, and Spain, from a health service viewpoint, bimatoprost/timolol was a slightly more effective as well as less costly treatment strategy

Limitations when use chloramphenicol-bcyclodextrins complexes in ophtalmic solutions buffered with boric acid/borax system

OpenAIRE

Todoran Nicoleta; Ciurba Adriana; Rédai Emőke; Ion V.; Lazăr Luminița; Sipos Emese

2014-01-01

Chloramphenicol eye drops are commonly prescribed in concentrations of 0.5-1% in the treatment of infectious conjunctivitis. In terms of ophthalmic solution preparation, the major disadvantage of chloramphenicol consists in its low solubility in water. The solubility is increased by substances that form chloramphenicol-complexes, for example: boric acid/borax or cyclodextrins. Objective: Experimental studies aimed to evaluate the potential advantages of enhancing the solubility and stability ...

Location of the internal carotid artery and ophthalmic artery segments for non-invasive intracranial pressure measurement by multi-depth TCD.

Science.gov (United States)

Hamarat, Yasin; Deimantavicius, Mantas; Kalvaitis, Evaldas; Siaudvytyte, Lina; Januleviciene, Ingrida; Zakelis, Rolandas; Bartusis, Laimonas

2017-12-01

The aim of the present study was to locate the ophthalmic artery by using the edge of the internal carotid artery (ICA) as the reference depth to perform a reliable non-invasive intracranial pressure measurement via a multi-depth transcranial Doppler device and to then determine the positions and angles of an ultrasonic transducer (UT) on the closed eyelid in the case of located segments. High tension glaucoma (HTG) patients and healthy volunteers (HVs) undergoing non-invasive intracranial pressure measurement were selected for this prospective study. The depth of the edge of the ICA was identified, followed by a selection of the depths of the IOA and EOA segments. The positions and angles of the UT on the closed eyelid were measured. The mean depth of the identified ICA edge for HTG patients was 64.3 mm and was 63.0 mm for HVs (p = 0.21). The mean depth of the selected IOA segment for HTG patients was 59.2 mm and 59.3 mm for HVs (p = 0.91). The mean depth of the selected EOA segment for HTG patients was 48.5 mm and 49.8 mm for HVs (p = 0.14). The difference in the located depths of the segments between groups was not statistically significant. The results showed a significant difference in the measured UT angles in the case of the identified edge of the ICA and selected ophthalmic artery segments (p = 0.0002). We demonstrated that locating the IOA and EOA segments can be achieved using the edge of the ICA as a reference point. OA: ophthalmic artery; IOA: intracranial segments of the ophthalmic artery; EOA: extracranial segments of the ophthalmic artery; ICA: internal carotid artery; UT: ultrasonic transducer; HTG: high tension glaucoma; SD: standard deviation; ICP: intracranial pressure; TCD: transcranial Doppler.

Comparison of Ocular Pulse Amplitude Lowering Effects of Preservative-Free Tafluprost and Preservative-Free Dorzolamide-Timolol Fixed Combination Eyedrops.

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Seo, Du Ri; Ha, Seung Joo

2015-01-01

To compare the ocular pulse amplitude (OPA) lowering effects of preservative-free tafluprost and dorzolamide-timolol fixed combination (DTFC) using dynamic contour tonometry. In total, 66 eyes of 66 patients with normal tension glaucoma (NTG) (n = 34) or primary open angle glaucoma (POAG) (n = 32) were included. Patients were divided into two groups: the preservative-free tafluprost-treated group (n = 33) and the preservative-free DTFC-treated group (n = 33). Intraocular pressure (IOP) was measured using Goldmann applanation tonometry (GAT). OPA was measured using dynamic contour tonometry; corrected OPA (cOPA) was calculated at baseline and at 1 week and 1, 3, and 6 months after treatment. After 6 months of treatment, tafluprost significantly reduced IOP (P < 0.001). The OPA lowering effects differed significantly between the two treatment groups (P = 0.003). The cOPA-lowering effect of tafluprost (1.09 mmHg) was significantly greater than that of DTFC (0.36 mmHg) after 6 months of treatment (P = 0.01). Tafluprost and DTFC glaucoma treatments provided marked OPA and IOP lowering effects. Tafluprost had a greater effect than DTFC; thus, this drug is recommended for patients at risk of glaucoma progression, due to the high OPA caused by large fluctuations in IOP.

Ophthalmic public health; the way ahead.

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Heidary, F; Rahimi, A; Gharebaghi, R

2012-01-01

Visual sciences have been progressing quickly in recent decades through globalization phenomenon. An enormous change has taken place in ocular health issues, however, there are various problems facing ophthalmic public health worldwide. In the previous years, the World Health Organization and the International Agency for the Prevention of Blindness in partnership launched the global initiative to eradicate avoidable blindness by the year 2020, VISION 2020 the Right to Sight. It has concentrated on the prevention of blindness disability and recognized a health issue-sight as a human right. In view of challenges ahead of visual sciences, close collaboration between international agencies at the global level to implement new strategies and monitor the progress will be mandatory. In these circumstances non-governmental organizations should not be neglected. World Sight Day 2012 would be a great opportunity to be a focus on importance of visual impairment as an important public health issue and discovering new challenges ahead.

Congenital glaucoma as an ophthalmic manifestation of Frank-Ter Haar syndrome.

Science.gov (United States)

Aktas, Zeynep; Karaca, Emine Esra; Dogan, Nurcan; Çakmak, Tugba; Unlu, Metin; Tok, Levent; Hasanreisoglu, Murat

2014-04-01

We report on a patient with Frank-Ter Haar syndrome that is associated with high intraocular pressures. A 21-day-old male patient was referred to our clinic for surgical treatment of congenital glaucoma. On ophthalmic examination, he had buphthalmos, mild corneal edema and high IOP readings in both eyes. The patient underwent uneventful trabeculotomy surgery, bilaterally. Marked bilateral anterior iris insertion was noted during the surgery. Childhood glaucoma may be associated with Frank-Ter Haar syndrome.

In vivo comparative study of ocular vasodilation, a relative indicator of hyperemia, in guinea pigs following treatment with bimatoprost ophthalmic solutions 0.01% and 0.03%

Directory of Open Access Journals (Sweden)

Abayomi B Ogundele

2010-06-01

Full Text Available Abayomi B Ogundele, David Earnest, Marsha A McLaughlinAlcon Research, Limited, Fort Worth, TX, USAObjective: The objective of this in vivo study was to compare the incidence of vasodilation in guinea pigs following topical administration of bimatoprost ophthalmic solutions 0.01% and 0.03%.Methods: The study comprised 20 guinea pigs assigned to 2 treatment groups (10 per treatment group to receive either bimatoprost 0.01% or bimatoprost 0.03%. Animals were hand-held under 2.75 × magnification to score ocular vasodilation (a measure of hyperemia, using a scoring system developed at Alcon Research, Ltd. Following baseline ocular scoring, each animal received a 30 μL dose to the left eye of either bimatoprost 0.01% (3 μg or bimatoprost 0.03% (9 μg. Vasodilation was again scored at 1, 2, 3, 4, 5 and 6 hours after dosing. Incidence of vasodilation was calculated as the percent of total eyes in each 2-hour time interval with scores ≥2.Results: The incidence of vasodilation was higher in the bimatoprost 0.01% treatment group (range, 45.0% to 60.0% than the bimatoprost 0.03% treatment group (range, 30.0% to 52.2% at all post-dosing time points.Conclusion: The 2 bimatoprost formulations elicited ocular vasodilation of long duration (>6 hours in the guinea pig model, with the bimatoprost 0.01% treatment group showing a higher incidence of ocular vasodilation than the bimatoprost 0.03% treatment group. Further clinical studies would be needed to determine whether the higher incidence of vasodilation may also be attributed to the increased BAK concentration in the bimatoprost 0.01% formulation.Keywords: bitamoprost, ocular vasodilation, hyperemia

Comparative studies of various hyaluronic acids produced by microbial fermentation for potential topical ophthalmic applications

DEFF Research Database (Denmark)

Guillaumie, Fanny; Furrer, Pascal; Felt-Baeyens, Olivia

2010-01-01

This work presents a comparative study of various hyaluronic acids (HA) produced by fermentation of either Bacillus subtilis or Streptococcus towards the selection of an optimal molecular weight (MW) HA for the preparation of topical ophthalmic formulations. The influence of HA MW on water binding...

Vascular resistance of central retinal and ophthalmic arteries in postmenopausal women after use of tibolone.

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de Souza, Marco Aurélio Martins; de Souza, Bruno Martins; Geber, Selmo

2012-03-01

The aim of this study was to evaluate the effect of tibolone on vascular resistance of the central retinal and ophthalmic artery in postmenopausal women and to compare this effect with that of placebo using transorbital ultrasound with Doppler velocimetry. We performed a prospective randomized, double-blinded, placebo-controlled study. A total of 100 healthy postmenopausal women (follicle-stimulating hormone, >40 IU/L) younger than 65 years were studied. The participants were randomly allocated to two groups: placebo (n = 50) and tibolone (2.5 mg; n = 50). Transorbital Doppler velocimetric ultrasound was performed before treatment and 80 days after. The mean age was similar in both groups. Participants who received tibolone did not show any difference in pulsatility index, resistance index, and systole/diastole ratio of the central retinal and ophthalmic arteries after treatment. The same was observed in participants who received placebo. Our study demonstrates that tibolone administration to healthy postmenopausal women does not affect the resistance of small-caliber cerebral arteries.

Safety in the use of compressed air versus oxygen for the ophthalmic patient.

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Rodgers, Laura A; Kulwicki, Anahid

2002-02-01

Oxygen, routinely administered during surgery to avoid hypoxia, poses risks including increased likelihood of surgical room fires and predisposition to retinal phototoxicity in patients. Compressed air to supplement ventilation may be safer than oxygen. The purpose of this study was to determine whether hypoxia occurs more frequently when compressed air replaces supplemental oxygen during ophthalmic surgery. A convenience sample of 111 patients was randomly assigned to receive supplemental oxygen (group 1) or compressed air (group 2). Patients with serious cardiac or pulmonary disease were excluded. Blood oxygen levels were monitored during surgery by pulse oximetry. Oxygen was administered to all group 2 patients whose oxygen saturation fell to less than 90% or by more than 5% below baseline. No differences were observed between groups in age, ASA classification, type of surgery, or anesthetic drugs or doses. Minor, but statistically higher oxygen values were observed in group 1. The frequency with which oxygen saturation decreased below 90% or below 5% of baseline was similar in both groups. Supplemental oxygen is not required routinely in selected patients undergoing ophthalmic surgery. By using compressed air, the risk of operating room fires and retinal phototoxicity may be reduced.

Polyethylene Naphthalate Scintillator: A Novel Detector for the Dosimetry of Radioactive Ophthalmic Applicators.

Science.gov (United States)

Flühs, Dirk; Flühs, Andrea; Ebenau, Melanie; Eichmann, Marion

2015-09-01

Dosimetric measurements in small radiation fields with large gradients, such as eye plaque dosimetry with β or low-energy photon emitters, require dosimetrically almost water-equivalent detectors with volumes of <1 mm(3) and linear responses over several orders of magnitude. Polyvinyltoluene-based scintillators fulfil these conditions. Hence, they are a standard for such applications. However, they show disadvantages with regard to certain material properties and their dosimetric behaviour towards low-energy photons. Polyethylene naphthalate, recently recognized as a scintillator, offers chemical, physical and basic dosimetric properties superior to polyvinyltoluene. Its general applicability as a clinical dosimeter, however, has not been shown yet. To prove this applicability, extensive measurements at several clinical photon and electron radiation sources, ranging from ophthalmic plaques to a linear accelerator, were performed. For all radiation qualities under investigation, covering a wide range of dose rates, a linearity of the detector response to the dose was shown. Polyethylene naphthalate proved to be a suitable detector material for the dosimetry of ophthalmic plaques, including low-energy photon emitters and other small radiation fields. Due to superior properties, it has the potential to replace polyvinyltoluene as the standard scintillator for such applications.

Medical therapy cost considerations for glaucoma.

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Fiscella, Richard G; Green, Amy; Patuszynski, Daniel H; Wilensky, Jacob

2003-07-01

To determine the calculated daily patient cost (cost minimization) of medical glaucoma therapy and review cost trends. Experimental, controlled, prospective study. The actual volume of various glaucoma medications or glaucoma medications with redesigned bottles was determined for most commercially available sizes of the tested products. The drops per milliliter based on the actual volume and the daily costs of the dosage schedules recommended by the manufacturers were compared. The cost of each bottle of medication was determined from the average wholesale price (AWP) in the United States. A comparison to 1999 prices where applicable will be analyzed to review costing trends. The generic timolol products (range, US dollars 0.38-US dollars 0.46 per day) were similar on a cost per day basis vs Betimol (Santen, Napa Valley, California, USA), Optipranolol (Bausch and Lomb Pharmaceuticals, Tampa, Florida, USA) and Timoptic (Merck, West Point, Pennsylvania, USA). Their percentage cost increase ranged from 5% to 22% since 1999, except for generic timolol XE gel-forming solution (48%). Betagan (Allergan, Irvine, California, USA), Betoptic S (Alcon Laboratories, Fort Worth, Texas, USA), and Ocupress (Novartis, Duluth, Georgia, USA) ranged from US dollars 0.88 to US dollars 1.11 per day, and their percentage cost increase ranged from 33% to 53%. Some brand-only products have raised their AWPs a greater percentage, including Betoptic S (37%), Iopidine (Alcon, Fort Worth, Texas, USA) (50%), Ocupress (Novartis Ophthalmics, Duluth, Georgia, USA) (53%), and Pilopine gel (Alcon, Fort Worth, Texas, USA) (32%). The mean cost per day for the topical carbonic anhydrase inhibitors Azopt (Alcon Laboratories; US dollars 1.33 per day) and Trusopt (Merck; US dollars 1.05 per day) differed from 1999 when prices were almost identical. Cosopt (Merck; timolol 0.5% plus dorzolamide 2%, US dollars 1.04 per day) was less than the cost of separate bottles of a topical carbonic anhydrase inhibitor

A Case of Hydranencephaly in Which Ophthalmic Examinations Were Performed

Directory of Open Access Journals (Sweden)

Shohei Eda

2016-09-01

Full Text Available Purpose: We performed ophthalmic examinations, including optical coherence tomography (OCT, on a case diagnosed with hydranencephaly. Case Report: This case involved a female infant born at the gestational age of 35 weeks and 4 days, with the birth weight of 2,152 g, who was one of monochorionic diamniotic twins, and the identical twin died in utero at the gestational age of 24 weeks. After that, examination by fetal echo indicated that she had microcephaly and ventriculomegaly. Postnatal magnetic resonance imaging (MRI of her head indicated microcephaly and significant enlargement of the lateral ventricle on both sides, with no obvious signs of elevated intracranial pressure. The brain parenchyma of both sides of the frontal lobe, parietal lobe, and occipital lobe had marked thinning, yet that of the temporal lobe, basal ganglia, thalamus, brain stem, and cerebellum had been maintained. Moreover, no obvious hematoma or neoplastic lesions were observed. Ophthalmic examinations indicated that both of her eyes had slight light reflex, attributed to optic nerve atrophy. Examination by use of a hand-held OCT system indicated a layered structure of the retina and thinning of the ganglion cell layer. Flicker electroretinogram (ERG examination by use of a hand-held ERG system indicated an almost normal wave. However, no clear visual reaction was observed when she was 10 months old. Conclusion: Our findings in this case of hydranencephaly revealed that even though the outer layer functions of the patient’s retina were maintained, extensive damage to her cerebral cortex resulted in poor visual function.

Fast separation and quantification of three anti-glaucoma drugs by high-performance liquid chromatography UV detection

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Mohamed Walash

2016-04-01

Full Text Available In this study, a simple and accurate high-performance liquid chromatography method was developed and validated for fast separation of three anti-glaucoma drugs: timolol maleate (TM, brimonidine tartrate (BM, and latanoprost (LP. Separation of the three drugs was achieved in < 6 minutes using a BDS Hypersil phenyl column and a mobile phase consisting of acetonitrile: 25mM phosphate buffer, pH 4.0 (50: 50, v/v at 1.2 mL/min with UV detection at 210 nm. The method was linear over the concentration ranges of 5.0–200.0 μg/mL, 2.0–80.0 μg/mL and 1.0–25.0 μg/mL with lower detection limits of 0.21 μg/mL, 0.10 μg/mL and 0.11 μg/mL for TM, BM and LP, respectively. The method was applied for the determination of two fixed-dose combination eye drops for the treatment of glaucoma, containing TM together with either BM or LP. Commercial samples of single-ingredient ophthalmic solutions containing the studied drugs were also successfully analyzed. The results obtained by the proposed method were favorably compared with those obtained by the comparison methods using Student's t test and the variance ratio F test.

Ophthalmic evaluation of long-term survivors of childhood acute lymphoblastic leukemia

International Nuclear Information System (INIS)

Weaver, R.G. Jr.; Chauvenet, A.R.; Smith, T.J.; Schwartz, A.C.

1986-01-01

Thirty-four long-term survivors of childhood acute lymphoblastic leukemia (ALL) underwent comprehensive ophthalmic examinations to detect retinopathy or other ocular sequelae. Sixteen of the 34 patients received whole brain radiation (greater than or equal to 2400 rad). All 18 patients in the non-radiated group had normal eye examinations, while 4 of 16 in the radiated group had ocular abnormalities. None of the ocular abnormalities could be definitely attributed to radiation and all patients had normal visual acuity. No radiation retinopathy was found in either group

Ophthalmic comlications of functional endoscopic sinus surgery

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Sergey A. Karpishchenko

2017-03-01

Full Text Available Functional endoscopic sinus surgery (FESS is an effective and safe surgical technique, which revolutionized the surgical management of nasal cavity and paranasal sinus diseases. The intimate connection between paranasal sinuses and the orbit places the orbital content at a risk of injury during sinus surgery, especially that of ethmoid sinuses. The orbit, the optic nerve, extraocular muscles and the lacrimal drainage system could be damaged during FESS. The risk of injury correlates to anatomical variations, degree and severity of disease, previous procedure results, and surgical experience. Ophthalmic complications can vary in severity from minor ones, such as localized hematomas, to extremely dangerous, such as optic nerve injury, that could lead to complete blindness. In order to minimize the risk of such complications, it is necessary to consider probable anatomic variations of paranasal sinuses and orbit, which are to be detected by CT scan before surgery.

Efficacy of a preservative-free formulation of fixed-combination bimatoprost and timolol (Ganfort PF in treatment-naïve patients vs previously treated patients

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Cordeiro MF

2015-08-01

Full Text Available M Francesca Cordeiro,1 Ivan Goldberg,2 Rhett Schiffman,3 Paula Bernstein,3 Marina Bejanian31Western Eye Hospital, Imperial College Healthcare NHS Trust, London, UK; 2Discipline of Ophthalmology, University of Sydney, Sydney, NSW, Australia; 3Allergan, Inc., Irvine, CA, USAPurpose: To evaluate, using subgroup analysis, the effect of treatment status on the intraocular pressure (IOP-lowering efficacy of a preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5% (FCBT PF.Methods: A primary, multicenter, randomized, double-masked, 12-week study compared the efficacy and safety of FCBT PF with preserved FCBT (Ganfort® in 561 patients diagnosed with glaucoma or ocular hypertension. For this analysis, eligible patients were treatment-naïve or had inadequate IOP lowering and underwent a washout of previous treatment. IOP (8 am, 10 am, and 4 pm was measured at baseline and weeks 2, 6, and 12. Subgroup analysis of the FCBT PF arm assessed changes in average eye IOP from baseline in treatment-naïve vs previously treated patients. To evaluate the effect of treatment status at baseline (treatment-naïve vs previously treated on IOP reduction in the FCBT PF treatment group, an analysis of covariance model was used with treatment status and investigator as fixed effects, and baseline average eye IOP, age, glaucoma diagnosis, and baseline average eye corneal thickness as covariates. P-values and the 95% confidence intervals were determined using the model.Results: In the FCBT PF arm, IOP mean changes from baseline ranged from -8.7 mmHg to -9.8 mmHg in treatment-naïve patients (N=50, compared with -7.3 mmHg to -8.5 mmHg in previously treated patients (N=228. Baseline IOP, age, glaucoma diagnosis, and corneal thickness significantly affected IOP reduction in the FCBT PF group. Adjusting for these covariates, FCBT PF had a greater IOP-lowering effect (0.8–1.7 mmHg in treatment-naïve patients than previously treated patients

The hen's egg chorioallantoic membrane (HET-CAM) test to predict the ophthalmic irritation potential of a cysteamine-containing gel: Quantification using Photoshop® and ImageJ.

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McKenzie, Barbara; Kay, Graeme; Matthews, Kerr H; Knott, Rachel M; Cairns, Donald

2015-07-25

A modified hen's egg chorioallantoic membrane (HET-CAM) test has been developed, combining ImageJ analysis with Adobe(®) Photoshop(®). The irritation potential of an ophthalmic medicine can be quantified using this method, by monitoring damage to blood vessels. The evaluation of cysteamine containing hyaluronate gel is reported. The results demonstrated that the novel gel formulation is non-irritant to the ocular tissues, in line with saline solution (negative control). In conclusion, the modification of the established HET-CAM test can quantify the damage to minute blood vessels. These results offer the possibility to formulate cysteamine in an ocular applicable gel formulation. Copyright © 2015 Elsevier B.V. All rights reserved.

Ophthalmic variables in rehabilitated juvenile Kemp's ridley sea turtles (Lepidochelys kempii).

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Gornik, Kara R; Pirie, Christopher G; Marrion, Ruth M; Wocial, Julika N; Innis, Charles J

2016-03-15

To determine central corneal thickness (total corneal thickness [TCT], epithelial thickness [ET], and stromal thickness [ST]), anterior chamber depth (ACD), and intraocular pressure (IOP) in Kemp's ridley sea turtles (Lepidochelys kempii). Prospective cross-sectional study. 25 healthy rehabilitated juvenile Kemp's ridley sea turtles. PROCEDURES; Body weight and straight-line standard carapace length (SCL) were recorded. All turtles underwent a complete anterior segment ophthalmic examination. Central TCT, ET, ST, and ACD were determined by use of a spectral-domain optical coherence tomography device. Intraocular pressure was determined with a rebound tonometer; the horse setting was used to measure IOP in all 25 turtles, and the undefined setting was also used to measure IOP in 20 turtles. For each variable, 3 measurements were obtained bilaterally. The mean was calculated for each eye and used for analysis purposes. The mean ± SD body weight and SCL were 3.85 ± 1.05 kg (8.47 ± 2.31 lb) and 29 ± 3 cm, respectively. The mean ± SD TCT, ET, ST, and ACD were 288 ± 23 μm, 100 ± 6 μm, 190 ± 19 μm, and 581 ± 128 μm, respectively. Mean ± SD IOP was 6.5 ± 1.0 mm Hg when measured with the horse setting and 3.8 ± 1.1 mm Hg when measured with the undefined setting. Results provided preliminary reference ranges for objective assessment of ophthalmic variables in healthy juvenile Kemp's ridley sea turtles.

Neuro-ophthalmic manifestation of neuromyelitis optica spectrum disorders

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Xiao-jun ZHANG

2014-10-01

Full Text Available Neuromyelitis optica spectrum disorders (NMOSDs include classic neuromyelitis optica (NMO, opticospinal multiple sclerosis (OSMS, limited form of NMO and isolated optic neuritis or myelitis accompanied by either systemic autoimmune diseases or typical MRI findings of NMO. The common neuro-ophthalmic features of NMOSDs include simultaneous or consecutive bilateral optic neuritis, more commonly seen optic disk edema and surrounding exudate, poor visual recovery, steroid responsiveness and dependency. Combined with serum aquaporin 4 (AQP4 antibody and brain MRI examination, these clinical features can be helpful to the early differential diagnosis between NMOSDs and MS. Some types of eye movement abnormalities have been reported in patients with NMOSDs, but further investigation needs to be done before the specificity of these features are confirmed. doi: 10.3969/j.issn.1672-6731.2014.10.003

Determination of feasibility and utility of microscope-integrated optical coherence tomography during ophthalmic surgery: the DISCOVER Study RESCAN Results.

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Ehlers, Justis P; Goshe, Jeff; Dupps, William J; Kaiser, Peter K; Singh, Rishi P; Gans, Richard; Eisengart, Jonathan; Srivastava, Sunil K

2015-10-01

Optical coherence tomography (OCT) has transformed the clinical management of a myriad of ophthalmic conditions. Applying OCT to ophthalmic surgery may have implications for surgical decision making and patient outcomes. To assess the feasibility and effect on surgical decision making of a microscope-integrated intraoperative OCT (iOCT) system. Report highlighting the 1-year results (March 2014-February 2015) of the RESCAN 700 portion of the DISCOVER (Determination of Feasibility of Intraoperative Spectral Domain Microscope Combined/Integrated OCT Visualization During En Face Retinal and Ophthalmic Surgery) study, a single-site, multisurgeon, prospective consecutive case series regarding this investigational device. Participants included patients undergoing ophthalmic surgery. Data on clinical characteristics were collected, and iOCT was performed during surgical milestones, as directed by the operating surgeon. A surgeon questionnaire was issued to each surgeon and was completed after each case to evaluate the role of iOCT during surgery and its particular role in select surgical procedures. Percentage of cases with successful acquisition of iOCT (ie, feasibility). Percentage of cases in which iOCT altered surgical decision making (ie, utility). During year 1 of the DISCOVER study, a total of 227 eyes (91 anterior segment cases and 136 posterior segment cases) underwent imaging with the RESCAN 700 system. Successful imaging (eg, the ability to acquire an OCT image of the tissue of interest) was obtained for 224 of 227 eyes (99% [95% CI, 98%-100%]). During lamellar keratoplasty, the iOCT data provided information that altered the surgeon's decision making in 38% of the cases (eg, complete graft apposition when the surgeon believed there was interface fluid). In membrane peeling procedures, iOCT information was discordant with the surgeon's impression of membrane peel completeness in 19% of cases (eg, lack of residual membrane or presence of occult membrane), thus

Staff dose of hospitalization in the treatment of patients in ophthalmic brachytherapy with 125 I

International Nuclear Information System (INIS)

Terron Leon, J. A.; Gomez Palacios, M.; Moreno Reyes, J. C.; Perales Molina, A.

2013-01-01

The objective of this work, therefore, has been the evaluation of the dose levels which nursing staff can receive in care for ophthalmic brachytherapy patients treated with 125 I from measurements made on the same, evaluating, in an experimental way, job security following the PR rules laid down for these treatments. (Author)

Safety and efficacy of MIM D3 ophthalmic solutions in a randomized placebo controlled Phase 2 clinical trial in patients with dry eye

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Meerovitch K

2013-06-01

Full Text Available Karen Meerovitch,1 Gail Torkildsen,2 John Lonsdale,3 Heidi Goldfarb,4 Teresa Lama,1 Garth Cumberlidge,1 George W Ousler III5 1Mimetogen Pharmaceuticals Inc, Montreal, QC, Canada; 2Andover Eye Associates, Andover, MA, USA; 3Central Maine Eye Care, Lewiston, ME, USA; 4SDC, Tempe, AZ, USA; 5Ora Inc, Andover, MA, USA Purpose: To evaluate the safety and efficacy of ophthalmic MIM-D3, a tyrosine kinase TrkA receptor agonist, in patients with dry eye. Design: A prospective, two-center, randomized, double-masked, placebo-controlled Phase 2 study. Methods: A total of 150 dry eye patients were randomized 1:1:1 to study medication (1% MIM-D3, 5% MIM-D3, or placebo and dosed twice daily (BID for 28 days. Key eligibility criteria included exacerbation in corneal staining and ocular discomfort in the Controlled Adverse Environment (CAESM on two visits, separated by 1 week of BID dosing with artificial tears. Safety and efficacy were evaluated at baseline, throughout treatment, and for 2 weeks post-treatment. The pre-specified primary outcome measures were fluorescein corneal staining post-CAE at day 28 and diary worst symptom scores over 28 days. Secondary outcomes included the pre-, post-, and the change from pre- to post-CAE fluorescein and lissamine green staining in both corneal and conjunctival regions, as well as individual diary symptoms. Results: The prespecified primary endpoints were not met. Compared with placebo, fluorescein corneal staining at day 28 was significantly improved (P < 0.05 in the 1% MIM-D3 group for the assessment of change from pre-CAE to post-CAE. In addition, following CAE exposure, patients in the 1% MIM-D3 group showed significant improvements versus placebo (P < 0.05 in inferior fluorescein and lissamine green staining after 14 and 28 days. Compared with placebo, patients in the 5% MIM-D3 group reported significantly lower daily diary scores for ocular dryness (P < 0.05. In a subgroup defined by higher symptom scores during

Hydroxychloroquine screening practice patterns within a large multispecialty ophthalmic practice.

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Au, Adrian; Parikh, Vishal; Modi, Yasha S; Ehlers, Justis P; Schachat, Andrew P; Singh, Rishi P

2015-09-01

To determine provider compliance with hydroxychloroquine screening following the revised recommendations published in 2011 by the American Academy of Ophthalmology. Evaluation of adherence to a screening protocol. Subjects were identified with hydroxychloroquine as a medication by electronic query at a large multispecialty ophthalmic practice. Patients were excluded if patients: (1) were screened by an outside physician; (2) lacked recorded height, weight, start date, or dosing; or (3) took hydroxychloroquine for malaria prophylaxis. Screening tests were stratified by ophthalmic subspecialty. Guidelines define proper screening as 1 subjective test-Humphrey visual field (HVF), and 1 objective test-spectral-domain optical coherence tomography (SD OCT), fundus autofluorescence (FAF), or multifocal electroretinography (mfERG). Adherence to guidelines was determined by categorizing practices as: (1) "appropriate"-consistent with guidelines; (2) "underscreened"-insufficient testing; or (3) "inappropriate"-no testing. The study comprised 756 patients with a mean age of 56 years undergoing 1294 screening visits. Twenty-one patients received initial screenings outside the institution. Most common screening tests employed included SD OCT (56.6%), 10-2 HVF (55.0%), and Amsler grid (40.0%). Of the 735 initial screenings, 341 (46.4%) were appropriately screened, 204 (27.8%) underscreened, and 190 (25.9%) inappropriately screened. Of those who presented solely for screening (560), 307 (54.8%) were appropriately screened, 144 (25.7%) underscreened, and 109 (19.5%) inappropriately screened. Of patients presenting for hydroxychloroquine screening, 54.8% of patients received appropriate evaluation, indicating lack of adherence to guidelines. Overall, SD OCT and 10-2 HVF were the preferred screening modalities, with FAF and mfERG less frequently ordered. Copyright © 2015 Elsevier Inc. All rights reserved.

[Pediatric case series in an ophthalmic camp in Turkana (Kenya)].

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Noval, S; Cabrejas, L; Jarrín, E; Ruiz-Guerrero, M; Ciancas, E

2013-12-01

Turkana is the largest district in Kenya, situated in the Northwest of the country. It features a semi-nomadic population of 850,000. Around 60% of population lives below the poverty threshold. The ratio of doctors is 1:75,000 inhabitants. Five ophthalmologists took part in the last deployment in November. Local staff had previously selected the patients from the rural areas, as well as in Lodwar, the capital of the district. Of the 371 patients who attended the clinic, 128 required surgery. To describe the pediatric population attended to in the last «Turkana Eye Project» Camp. Description of the ophthalmic pathologies of the children seen in the clinic in this surgical camp, and the diagnostic and therapeutic options according to the limitations of the environment. Of the 371 patients, 54 were younger than 15 years old (14.5%). Four children had surgery (3.25% of the 128 patients). In 2 more cases surgery was the indicated but not performed. Therefore, of the total of 54 cases, 6 could be considered as surgical (11.1%), and 17 suffered ophthalmic problems other than refraction defects, or mild ocular surface pathologies: traumatic cataracts, neuropathies, impetigo, exophthalmos, retinal dystrophies, dermoid cysts, or nyctalopia. The etiology was traumatic in four of the 17 children (23.5%). Surgical camps are increasing in the developing countries. They are usually focused on particular pathologies, such as cataracts or trachoma. Our case series shows the importance of pediatric teams and the need to be prepared to face complex pediatric pathologies. Copyright © 2012 Sociedad Española de Oftalmología. Published by Elsevier Espana. All rights reserved.

Optimization of 125I ophthalmic plaque brachytherapy

International Nuclear Information System (INIS)

Astrahan, M.A.; Luxton, G.; Jozsef, G.; Liggett, P.E.; Petrovich, Z.

1990-01-01

Episcleral plaques containing 125 I sources are often used in the treatment of ocular melanoma. Within four years post-treatment, however, the majority of patients experience some visual loss due to radiation retinopathy. The high incidence of late complications suggests that careful treatment optimization may lead to improved outcome. The goal of optimization would be to reduce the magnitude of vision-limiting complications without compromising tumor control. We have developed a three-dimensional computer model for ophthalmic plaque therapy which permits us to explore the potential of various optimization strategies. One simple strategy which shows promise is to maximize the ratio of dose to the tumor apex (T) compared to dose to the macula (M). By modifying the parameters of source location, activity distribution, source orientation, and shielding we find that the calculated T:M ratio can be varied by a factor of 2 for a common plaque design and posterior tumor location. Margins and dose to the tumor volume remain essentially unchanged

Risk of Hemorrhage during Needle-Based Ophthalmic Regional Anesthesia in Patients Taking Antithrombotics: A Systematic Review.

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Augusto Takaschima

Full Text Available Patients undergoing ophthalmic surgery are usually elderly and, due to systemic disease, may be on long-term therapy, such as antithrombotic agents. Rates of hemorrhagic complications associated with invasive procedures may be increased by the use of anticoagulants and antiplatelet agents.To compare the incidence of hemorrhagic complications in patients undergoing needle-based ophthalmic regional anesthesia between patients on antithrombotic therapy and those not on such therapy.A systematic review was conducted by two independent reviewers based on searches of Cochrane, LILACS, PubMed, Scopus, Web of Science, and the "gray" literature (Google Scholar. The end search date was May 8, 2015, across all databases.Five studies met the eligibility criteria. In three studies, individual risk of bias was low, and in two of them, moderate. In all studies, no differences regarding mild to moderate incidence of hemorrhagic complications were found between patients using antithrombotics (aspirin, clopidogrel, and warfarin and those not using them. Rates of severe hemorrhagic complication were very low (0.04% in both groups, supporting the safety of needle blocks, even in patients using antithrombotics. High heterogeneity across studies prevented meta-analysis. Limitations to these results include low statistical power in three experimental studies and a large 95% confidence interval in the two retrospective cohorts.In this review, none of the selected studies showed significant bleeding related to needle-based ophthalmic regional anesthesia in association with the use of aspirin, clopidogrel, or vitamin K inhibitors. Since the available data is not powerful enough to provide a reliable evaluation of the true effect of antithrombotics in this setting, new studies to address these limitations are necessary.

Ocular surface distribution and pharmacokinetics of a novel ophthalmic 1% azithromycin formulation.

Science.gov (United States)

Akpek, Esen Karamursel; Vittitow, Jason; Verhoeven, Rozemarijn S; Brubaker, Kurt; Amar, Thierry; Powell, Kendall D; Boyer, José L; Crean, Christopher

2009-10-01

To investigate the ocular distribution of 1% azithromycin ophthalmic solution and the effect of polycarbophil-based mucoadhesive formulation on ocular tissue levels of azithromycin after single and multiple topical administrations in the rabbit eye. Rabbits were treated with either a single administration of 1% azithromycin solution with or without polycarbophil, or with multiple administrations of 1% azithromycin solution in polycarbophil. Drug concentrations were measured using LC/MS/MS. Conjunctiva, cornea, aqueous humor, and tear samples were analyzed over a period of 144 h after a single administration of azithromycin with or without polycarbophil. Eyelid, conjunctiva, cornea, aqueous humor, and tear samples were collected over a period of 288 h during and after multiple administrations of azithromycin. Azithromycin was rapidly absorbed and distributed in the ocular tissues, reaching within 5 min, concentrations of 10,539 microg/mL in tear film, 108 microg/g in conjunctiva, and 40 microg/g in the cornea. The drug demonstrated tissue-specific half-lives of 15, 63, and 67 h, respectively. Following multiple administrations, the drug gradually accumulated. The polycarbophil formulation increased the bioavailability of the drug, producing peak concentrations that were between 5- and 12-fold higher than those without polycarbophil. Azithromycin also distributed rapidly in the eyelids, reaching peak concentrations of 180 mug/g at the end of the 7-day treatment, and was eliminated with a half-life of 125 h. Six days after treatment was discontinued, eyelid levels of azithromycin were above 40 microg/g. Sustained and high concentrations were encountered with 7-day approved administration of 1% azithromycin formulation (AzaSite, Inspire Pharmaceuticals, Inc., Durham, NC) within all ocular surface tissues, particularly the lids. Many ocular surface disorders involving the tear film, eyelids, and adnexal structures are associated with chronic, low-grade bacterial

Effect on Intraocular Pressure of Switching from Latanoprost and Travoprost Monotherapy to Timolol Fixed Combinations in Patients with Normal-Tension Glaucoma

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Ryoko Igarashi

2014-01-01

Full Text Available Purpose. To evaluate the effect on intraocular pressure (IOP of switching from latanoprost and travoprost monotherapy to timolol fixed combinations in Japanese patients with normal-tension glaucoma (NTG. Methods. 27 NTG patients (54 eyes were compared IOP, superficial punctuate keratitis (SPK scores, and conjunctival injection scores in eyes treated with prostaglandin (PG or PG analog/beta-blocker (PG/b fixed-combination 6 months after the change in therapy. Results. The mean baseline intraocular pressure was 17.4±1.59 mmHg in eyes receiving PG therapy only and 17.4±1.69 mmHg in eyes switched to PG/b. Switching to fixed combination therapy from PG monotherapy, the mean IOP was 13.1±1.79 mmHg (P<0.001  (-24.71% reduction from baseline at 6 months. The mean conjunctival injection score was 0.69 for eyes on PG monotherapy and 0.56 for eyes on fixed combination therapy (P=0.028. The mean SPK scores were 0.46 and 0.53. This difference was not statistically significant (P=0.463. Conclusions. Switching from PG monotherapy to PG/b fixed combination therapy for NTG resulted in a greater intraocular pressure reduction than PG alone without increasing the number of instillations.

Ophthalmic nepafenac use in the Netherlands and Denmark

DEFF Research Database (Denmark)

Margulis, Andrea V.; Houben, Eline; Hallas, Jesper

2017-01-01

Purpose: To describe nepafenac use in the Netherlands and Denmark with reference to its approved indications. For context, we also describe the use of ketorolac and diclofenac. Methods: We identified users in the PHARMO Database Network (the Netherlands, 2008–2013) and the Danish national health...... registers (Denmark, 1994–2014). We described prevalence of cataract surgery and duration of use in patients with cataract surgery with and without diabetes. Results: In the Netherlands, 9530 nepafenac users (mean age, 71 years; 60% women) contributed 12 691 therapy episodes, of which 21% had a recently...... dispensed. Use patterns of nepafenac, ketorolac and diclofenac were roughly similar in the Netherlands, but not in Denmark. Conclusion: Less than half of therapy episodes were related to cataract surgery; around 90% of episodes with surgery were within the approved duration. Underrecording of ophthalmic...

Fixed-combination treatments for intraocular hypertension in Chinese patients – focus on bimatoprost-timolol

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Fang Y

2015-05-01

Full Text Available Yuan Fang,1,* Zhihong Ling,1,* Xinghuai Sun1–4 1Department of Ophthalmology and Visual Science, Eye, Ear, Nose and Throat Hospital, Shanghai Medical College, Fudan University, 2Shanghai Key Laboratory of Visual Impairment and Restoration, 3Key Laboratory of Myopia, Ministry of Health, 4State Key Laboratory of Medical Neurobiology, Institutes of Brain Science, Fudan University, Shanghai, People’s Republic of China *These authors contributed equally to this work Abstract: Glaucoma is a common eye disease that can lead to irreversible vision loss if left untreated. The early diagnosis and treatment of primary open-angle glaucoma is challenging, and visual impairment in Chinese glaucoma patients is a serious concern. Most of these patients need more than one topical antiglaucoma agent to control their intraocular pressures (IOPs. In the People’s Republic of China, the daily cost of different glaucoma medication varies greatly, and the treatment habits differ throughout the country. Prostaglandin analogs (PGAs are recommended as first-line monotherapy, because of their efficacy and low risk of systemic side effects. Fixed-combination drops, particularly PGA-based fixed combinations, have recently been developed and used in patients with progression or who have failed to achieve their target IOPs. Here, we reviewed the current literature on the use of bimatoprost-timolol fixed combination (BTFC in the People’s Republic of China. BTFC has achieved good efficacy and tolerability in Chinese clinical trials. In addition, BTFC is more cost effective compared with other fixed combinations available in the People’s Republic of China. Fixed-combination drops may offer benefits, such as keeping the ocular surface healthy, convenience of administration, and improvement in long-term adherence and quality of life. Therefore, BTFC has great potential for the treatment of Chinese glaucoma patients. However, the long-term efficacy of BTFC, comparisons

Comparison of ophthalmic sponges and extraction buffers for quantifying cytokine profiles in tears using Luminex technology.

Science.gov (United States)

Inic-Kanada, Aleksandra; Nussbaumer, Andrea; Montanaro, Jacqueline; Belij, Sandra; Schlacher, Simone; Stein, Elisabeth; Bintner, Nora; Merio, Margarethe; Zlabinger, Gerhard J; Barisani-Asenbauer, Talin

2012-01-01

Evaluating cytokine profiles in tears could shed light on the pathogenesis of various ocular surface diseases. When collecting tears with the methods currently available, it is often not possible to avoid the tear reflex, which may give a different cytokine profile compared to basal tears. More importantly, tear collection with glass capillaries, the most widely used method for taking samples and the best method for avoiding tear reflex, is impractical for remote area field studies because it is tedious and time-consuming for health workers, who cannot collect tears from a large number of patients with this method in one day. Furthermore, this method is uncomfortable for anxious patients and children. Thus, tears are frequently collected using ophthalmic sponges. These sponges have the advantage that they are well tolerated by the patient, especially children, and enable standardization of the tear collection volume. The aim of this study was to compare various ophthalmic sponges and extraction buffers to optimize the tear collection method for field studies for subsequent quantification of cytokines in tears using the Luminex technology. Three ophthalmic sponges, Merocel, Pro-ophta, and Weck-Cel, were tested. Sponges were presoaked with 25 cytokines/chemokines of known concentrations and eluted with seven different extraction buffers (EX1-EX7). To assess possible interference in the assay from the sponges, two standard curves were prepared in parallel: 1) cytokines of known concentrations with the extraction buffers and 2) cytokines of known concentrations loaded onto the sponges with the extraction buffers. Subsequently, a clinical assessment of the chosen sponge-buffer combination was performed with tears collected from four healthy subjects using 1) aspiration and 2) sponges. To quantify cytokine/chemokine recovery and the concentration in the tears, a 25-plex Cytokine Panel and the Luminex xMap were used. This platform enables simultaneous measurement of

Comparison of ophthalmic sponges and extraction buffers for quantifying cytokine profiles in tears using Luminex technology

Science.gov (United States)

Inic-Kanada, Aleksandra; Nussbaumer, Andrea; Montanaro, Jacqueline; Belij, Sandra; Schlacher, Simone; Stein, Elisabeth; Bintner, Nora; Merio, Margarethe; Zlabinger, Gerhard J.

2012-01-01

Purpose Evaluating cytokine profiles in tears could shed light on the pathogenesis of various ocular surface diseases. When collecting tears with the methods currently available, it is often not possible to avoid the tear reflex, which may give a different cytokine profile compared to basal tears. More importantly, tear collection with glass capillaries, the most widely used method for taking samples and the best method for avoiding tear reflex, is impractical for remote area field studies because it is tedious and time-consuming for health workers, who cannot collect tears from a large number of patients with this method in one day. Furthermore, this method is uncomfortable for anxious patients and children. Thus, tears are frequently collected using ophthalmic sponges. These sponges have the advantage that they are well tolerated by the patient, especially children, and enable standardization of the tear collection volume. The aim of this study was to compare various ophthalmic sponges and extraction buffers to optimize the tear collection method for field studies for subsequent quantification of cytokines in tears using the Luminex technology. Methods Three ophthalmic sponges, Merocel, Pro-ophta, and Weck-Cel, were tested. Sponges were presoaked with 25 cytokines/chemokines of known concentrations and eluted with seven different extraction buffers (EX1–EX7). To assess possible interference in the assay from the sponges, two standard curves were prepared in parallel: 1) cytokines of known concentrations with the extraction buffers and 2) cytokines of known concentrations loaded onto the sponges with the extraction buffers. Subsequently, a clinical assessment of the chosen sponge-buffer combination was performed with tears collected from four healthy subjects using 1) aspiration and 2) sponges. To quantify cytokine/chemokine recovery and the concentration in the tears, a 25-plex Cytokine Panel and the Luminex xMap were used. This platform enables simultaneous

Ophthalmic artery chemosurgery: A nursing perspective

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Mary Elizabeth Davis

2017-01-01

Full Text Available Retinoblastoma (RB is the most common primary cancer to affect the eyes in children with approximately 350 cases/year in the United States and 8000 worldwide. Today, sadly, 50% of children with RB worldwide die from their disease. In our experience, utilization of ophthalmic artery chemosurgery (OAC has transformed the treatment plan for patients; with over 1500 procedures performed, our survival rate exceeds 98%. It is now our standard first-line therapy for RB. OAC is a surgical outpatient procedure which delivers concentrated doses of chemotherapy directly to the tumor without the toxicities of systemic chemotherapy. Our team approach and nursing management of these patients are the focus of this article. Nursing navigation and collaboration after OAC is vital and requires a combined effort by the nurses along with physicians, interventional radiologists, and the patient's families to ensure appropriate follow-up is established. Proper patient education throughout the process is crucial as is open and available communication for parents of patients with the nursing staff. The success in our treatment of this disease can be much accredited to the multidisciplinary team approach, with nursing playing an integral part in the support and management of these patients.

Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study.

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Tauber, Joseph; Karpecki, Paul; Latkany, Robert; Luchs, Jodi; Martel, Joseph; Sall, Kenneth; Raychaudhuri, Aparna; Smith, Valerie; Semba, Charles P

2015-12-01

Lifitegrast is an integrin antagonist that decreases T-cell-mediated inflammation associated with dry eye disease (DED). We report the results of OPUS-2, a phase III study evaluating the efficacy and safety of lifitegrast compared with placebo for the treatment of DED. A 12-week, multicenter, randomized, prospective, double-masked, placebo-controlled clinical trial. Adults aged ≥18 years with use of artificial tears within 30 days, inferior corneal staining score ≥0.5 (0-4 scale), Schirmer tear test (without anesthesia) ≥1 and ≤10 mm, and eye dryness score ≥40 (0-100 visual analogue scale [VAS]). Subjects were randomized 1:1 after 14-day placebo run-in to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 days. Co-primary efficacy end points were change, from baseline to day 84, in eye dryness score (VAS, both eyes) and inferior corneal fluorescein staining score in the designated study eye. Secondary end points were change, from baseline to day 84, in ocular discomfort score (0-4 scale) in study eye, eye discomfort score (VAS), total corneal staining score in the study eye, and nasal conjunctival lissamine green staining score (0-4 scale) in the study eye. Treatment-emergent adverse events (TEAEs) were recorded. A total of 718 subjects were randomized: placebo, n = 360; lifitegrast, n = 358 (intent-to-treat population). Lifitegrast-treated subjects experienced greater improvement in eye dryness than placebo-treated subjects (treatment effect, 12.61; 95% confidence interval [CI], 8.51-16.70; P < 0.0001). There was no between-group difference in inferior corneal staining (treatment effect, 0.03; 95% CI, -0.10 to 0.17; P = 0.6186). There was nominally significant improvement of secondary symptom end points among lifitegrast-treated subjects: ocular discomfort (nominal P = 0.0005) and eye discomfort (nominal, P < 0.0001). There were no between-group differences on secondary signs: total corneal staining and nasal lissamine staining. More

Ophthalmic Vascular Events after Primary Unilateral Intra-arterial Chemotherapy for Retinoblastoma in Early and Recent Eras.

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Dalvin, Lauren A; Ancona-Lezama, David; Lucio-Alvarez, J Antonio; Masoomian, Babak; Jabbour, Pascal; Shields, Carol L

2018-06-16

To assess risk factors for ophthalmic vascular events after intra-arterial chemotherapy (IAC) for retinoblastoma. Retrospective cohort study. Patients who received unilateral IAC as primary treatment for retinoblastoma from January 1, 2009, to November 30, 2017, at a single center. Records were reviewed for patient demographics, tumor features, IAC parameters, and treatment-related vascular events in the early IAC era (2009-2011) compared with the recent era (2012-2017) using the t test and Fisher exact test. Change in event rates over time was assessed using Poisson regression analysis, with Spearman's rho used to test correlation. Rate of IAC-induced ophthalmic vascular events. There were 243 chemotherapy infusions in 76 eyes of 76 patients, divided into early (22 eyes, 57 infusions) and recent (54 eyes, 186 infusions) eras. Intra-arterial chemotherapy consisted of melphalan (243 infusions), topotecan (124 infusions), and carboplatin (9 infusions). A comparison (early vs. recent era) revealed fewer mean number of infusions (2.6 vs. 3.4, P = 0.02) with similar mean patient age and presenting tumor features. Event rates decreased over time (P early era vs. recent era) in the recent era (59% vs. 9% per eye, 23% vs. 3% per infusion, P age (P = 0.75), tumor diameter (P = 0.32), tumor thickness (P = 0.59), or cumulative dosage of melphalan (P = 0.13) or topotecan (P = 0.59). There were no IAC-induced vascular events in 72 infusions of 21 consecutively treated eyes in 2016 to 2017. Ophthalmic vascular events after IAC have decreased from the early era (2009-2011) through the current era (2012-2017) at this center. Experience performing this highly specialized procedure could be an important factor predicting IAC-related vascular events. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

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Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2009-03-01

Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P suspension 0.6% given 3 times daily for 5 days

Decomposition of pilocarpine eye drops assessed by a highly efficient high pressure liquid chromatographic method

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Kuks, P. F.; Weekers, L. E.; Goldhoorn, P. B.

1990-01-01

A rapid high-resolution high pressure liquid chromatographic method was developed for assaying pilocarpine. Pilocarpine in ophthalmic solutions decomposes fairly rapidly to give isopilocarpine, pilocarpic acid and isopilocarpic acid. The quality of an ophthalmic solution can be assessed by assaying

Preliminary results following the use of a fixed combination of timolol–brimonidine in patients with ocular hypertension and primary open-angle glaucoma

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Dimitris Papaconstantinou

2009-03-01

Full Text Available Dimitris Papaconstantinou1, Ilias Georgalas2, Nikolaos Kourtis1, Christos Pitsas1, Efthimios Karmiris1, Chrysanthi Koutsandrea1, Ioannis Ladas1, Gerasimos Georgopoulos11Department of Ophthalmology, “G Gennimatas” Hospital of Athens, University of Athens, Athens, Greece; 2Department of Ophthalmology, “G Gennimatas” Hospital of Athens, NHS, Athens, Greece Purpose: The purpose of this prospective study was to evaluate the efficacy in intraocular pressure (IOP control and the tolerance of a topically administered fixed combination of timolol–brimonidine in 50 patients with ocular hypertension and primary open-angle glaucoma.Methods: After determining a baseline IOP, the fixed combination timolol–brimonidine was used twice daily for two months, while IOP, ophthalmic signs, and/or symptoms were monitored.Results: The mean IOP value was decreased from 23.09 mm Hg (±1.98 SD to 17.46 mm Hg (±1.47 SD during the 1st month (paired Student’s t test = 9.88 και p < 0.001, and to 17.51 mm Hg (±1.43 SD in the 2nd month. Between the 1st and 2nd month, no statistical difference was observed (paired Student’s t test = 0.02 και p < 0.1. In 8% of the patients during the 1st month and 10% of patients in the 2nd month, some ophthalmic signs were observed, while only mild ophthalmic symptoms were reported in 6% and 8% of the patients, respectively.Conclusions: In conclusion, the fixed combination of timolol–brimonidine has a satisfactory IOP-lowering effect without any serious side effects due to the topical use. Keywords: fixed combination 0.2% brimonidine–0.5% timolol, ocular hypertension, primary open-angle glaucoma

Imaging of Dual Ophthalmic Arteries: Identification of the Central Retinal Artery

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Louise Louw

2014-01-01

Full Text Available Identification of the origin of the central retinal artery (CRA is imperative in tailoring angiographic studies to resolve a given clinical problem. A case with dual ophthalmic arteries (OAs, characterized by different origins and distinct branching patterns, is documented for training purposes. Pre-clinical diagnosis of a 9-year-old child who presented with a sharp wire in the left-side eyeball was primarily corneal laceration. For imaging, a selected six-vessel angiographic study with the transfemoral approach was performed. Embolization was not required and the wire could be successfully removed. Right-side OA anatomy was normal, while left-side dual OAs with external carotid artery (ECA and internal carotid artery (ICA origins were seen. The case presented with a left-side meningo-ophthalmic artery (M-OA anomaly via the ECA, marked by a middle meningeal artery (MMA (origin: Maxillary artery; course: Through foramen spinosum with normal branches (i.e. anterior and posterior branches, and an OA variant (course: Through superior orbital fissure with a distinct orbital branching pattern. A smaller OA (origin: ICA; course: Through optic foramen with a distinct ocular branching pattern presented with the central retinal artery (CRA. The presence of the dual OAs and the M-OA anomaly can be explained by disturbed evolutionary changes of the primitive OA and stapedial artery during development. The surgical interventionist must be aware of dual OAs and M-OA anomalies with branching pattern variations on retinal supply, because of dangerous extracranial-intracranial anastomotic connections. It is of clinical significance that the origin of the CRA from the ICA or ECA must be determined to avoid complications to the vision.

Microbiological evaluation of various parameters in ophthalmic operating rooms. The need to establish guidelines.

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Kelkar Uday

2003-01-01

Full Text Available Purpose: Postoperative infections can be caused by a contaminated environment, unsterile equipment, contaminated surfaces, and infected personnel as well as contaminated disinfectants. In order to establish guidelines for microbiological monitoring, a detailed microbiological surveillance was carried out in an ophthalmic hospital. Method: Over a period of 21 months, we assessed environmental Bacteria Carrying Particle (BCP load and surface samples weekly (n=276; the autoclaving system once a month and repeated whenever the process failed (n= 24; the air conditioning filters for fungal growth once in four months (n = 15, and the disinfectant solution for contamination once in two months (n = 10. Additionally, the personnel involved directly in surgery were screened for potential pathogens such as Staphylococcus aureus and β haemolytic streptococci. Result: On 14 (5.07% occasions the environment in the operating rooms had a significant risk of airborne infections. Sterilisation of instruments in the autoclaves was unsatisfactory on 4 (16.66 % occasions. Samples from the filters of the air-conditioning units yielded potentially pathogenic fungi on 3 (20% occasions. Personnel sampling revealed that 5 (8.77% individuals harboured β haemolytic Streptococci in the throat and 4 (7.01 % harboured S. aureus in the nasal cavity. The samples of disinfectant in use were not contaminated. Conclusion: There is a need to standardise microbiological evaluation protocols for operating rooms.

Optimization of sup 125 I ophthalmic plaque brachytherapy

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Astrahan, M.A.; Luxton, G.; Jozsef, G.; Liggett, P.E.; Petrovich, Z. (Univ. of Southern California School of Medicine, Los Angeles (USA))

1990-11-01

Episcleral plaques containing {sup 125}I sources are often used in the treatment of ocular melanoma. Within four years post-treatment, however, the majority of patients experience some visual loss due to radiation retinopathy. The high incidence of late complications suggests that careful treatment optimization may lead to improved outcome. The goal of optimization would be to reduce the magnitude of vision-limiting complications without compromising tumor control. We have developed a three-dimensional computer model for ophthalmic plaque therapy which permits us to explore the potential of various optimization strategies. One simple strategy which shows promise is to maximize the ratio of dose to the tumor apex (T) compared to dose to the macula (M). By modifying the parameters of source location, activity distribution, source orientation, and shielding we find that the calculated T:M ratio can be varied by a factor of 2 for a common plaque design and posterior tumor location. Margins and dose to the tumor volume remain essentially unchanged.

Triple-A syndrome with prominent ophthalmic features and a novel mutation in the AAAS gene: a case report

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Stuart Caroline

2004-06-01

Full Text Available Abstract Background Triple-A syndrome (Allgrove syndrome is an autosomal recessive disorder characterized by adrenal insufficiency, alacrima, achalasia, and – occasionally – autonomic instability. Mutations have been found in the AAAS gene on 12q13. Case presentation We present the case of a 12 year-old boy with classic systemic features of triple-A syndrome and several prominent ophthalmic features, including: accommodative spasm, dry eye, superficial punctate keratopathy, and pupillary hypersensitivity to dilute pilocarpine. MRI showed small lacrimal glands bilaterally. DNA sequencing of PCR-amplified fragments from the 16 exons of the AAAS gene revealed compound heterozygosity for a new, out-of-frame 5-bp deletion in exon 15, c1368-1372delGCTCA, and a previously-described nonsense mutation in exon 9, c938C>T, R286X. Conclusions In addition to known ophthalmic manifestations, triple-A syndrome can present with accommodative dysregulation and ocular signs of autonomic dysfunction.

Stimuli-sensitive hydrogels: A novel ophthalmic drug delivery system

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Singh Vinod

2010-01-01

Full Text Available Background: Stimuli-sensitive hydrogels are three-dimensional, hydrophilic, polymeric networks capable of imbibing large amounts of water or biological fluids on stimulation, such as pH, temperature and ionic change. Aim: To develop hydrogels that are sensitive to stimuli, i.e. pH, in the cul-de-sac of the eye for providing a prolonged effect and increased bioavailability with reduction in frequency of administration. Materials and Methods: Hydrogels were formulated by using timolol maleate as the model drug, polyacrylic acid as the gelling agents, hydroxyl ethyl cellulose as the viscolizer and sodium chloride as the isotonic agent. Stirring of ingredients in pH 4 phosphate buffer at high speed was carried out. The dynamic dialysis technique was used for drug release studies. In vivo study for reduction in intraocular pressure was carried out by using albino rabbits. Statistical Analysis: Drug release studies data were used for statistical analysis in first-order plots, Higuchi plots and Peppas exponential plots. Student t-test was performed for in vivo study. Results: Viscosity of the hydrogel increases from 3.84 cps to 9.54 cps due to change in pH 4 to pH 7.4. The slope value of the Peppas equation was found to be 0.3081, 0.3743 and 0.2964. Up to 80% of drug was released in an 8 h drug release study. Sterile hydrogels with no ocular irritation were obtained. Conclusions: Hydrogels show increase in viscosity due to change in pH. Hydrogels were therapeutically effacious, stable, non-irritant and showed Fickian diffusion. In vivo results clearly show a prolonged reduction in intraocular pressure, which was helpful for reduction in the frequency of administration.

Development and Validation of a Precise and Stability Indicating LC Method for the Determination of Benzalkonium Chloride in Pharmaceutical Formulation Using an Experimental Design

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Harshal K. Trivedi

2010-01-01

Full Text Available A simple, precise, shorter runtime and stability indicating reverse-phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC preservative in pharmaceutical formulation of sparfloxacin eye drop. The method was successfully applied for determination of benzalkonium chloride in various ophthalmic formulations like latanoprost, timolol, dexametasone, gatifloxacin, norfloxacin, combination of moxifloxacin and dexamethasone, combination of nepthazoline HCl, zinc sulphate and chlorpheniramine maleate, combination of tobaramycin and dexamethasone, combination of phenylephrine HCl, naphazoline HCl, menthol and camphor. The RP-LC separation was achieved on an Purospher Star RP-18e 75 mm × 4.0 mm, 3.0 μ in the isocratic mode using buffer: acetonitrile (35: 65, v/v, as the mobile phase at a flow rate of 1.8 mL/min. The methods were performed at 215 nm; in LC method, quantification was achieved with PDA detection over the concentration range of 50 to 150 μg/mL. The method is effective to separate four homologs with good resolution in presence of excipients, sparfloxacin and degradable compound due to sparfloxacin and BKC within five minutes. The method was validated and the results were compared statistically. They were found to be simple, accurate, precise and specific. The proposed method was validated in terms of specificity, precision, recovery, solution stability, linearity and range. All the validation parameters were within the acceptance range and concordant to ICH guidelines.

Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients

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Stonecipher, Karl G; Chia, Jenny; Onyenwenyi, Ahunna; Villanueva, Linda; Hollander, David A

2013-01-01

Karl G Stonecipher,1 Jenny Chia,2 Ahunna Onyenwenyi,2 Linda Villanueva,2 David A Hollander2 1TLC Laser Eye Centers, Greensboro, NC, 2Allergan, Inc., Irvine, CA, USA Background: Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis®) use in dry eye patients and determine if there were any differences in use based o...

Effect of vitamin A palmitate ophthalmic gel adjunctive therapy on tear film stability and inflammatory cytokines in patients with dry eye

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Ya-Yuan Lu

2018-06-01

Full Text Available AIM:To investigate the effect of sodium hyaluronate eye drops combined with vitamin A palmitate ophthalmic gel on levels of tear film stability and inflammatory cytokines in patients with dry eye. METHODS: A total of 100 patients with dry eye treated in our hospital from January 2015 to February 2017 were randomly divided into control group and observation group, 50 cases in each group. Patients in the control group were treated with sodium hyaluronate eye drops. Patients in the observation group were given vitamin A palmitate ophthalmic gel on the basis of the control group, and then the clinical efficacy, tear film stability and the level of inflammatory cytokines were detected in the two groups. RESULTS: After treatment, the levels of BUT and SⅠt in both groups increased significantly compared with that before treatment, and FL was significantly lower than that before treatment. The levels of BUT and SⅠt in the observation group after treatment were 11.24±0.22s and 11.4±0.17mm/5min respectively, which was high than that of control groups(PPPPCONCLUSION: Sodium hyaluronate eye drops combined with vitamin A palmitate ophthalmic gel can relieve the symptoms of patients with dry eye effectively, increase the stability of tear film, and reduce the levels of inflammatory factors in tears, which is reliable in clinical application.

Evaluation of dacryocystorhinostomy using optical coherence tomography and rebamipide ophthalmic suspension

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Fujimoto M

2014-08-01

Full Text Available Masahiro Fujimoto,1 Ken Ogino,1 Chika Miyazaki,1,2 Miou Hirose,1,3 Hiroko Matsuyama,1,4 Takeshi Moritera,1,5 Nagahisa Yoshimura1 1Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan; 2Department of Ophthalmology, Hyogo Prefectural Tsukaguchi Hospital, Hyogo, Japan; 3Department of Ophthalmology, Hyogo Prefectural Amagasaki Hospital, Hyogo, Japan; 4Department of Ophthalmology, National Hospital Organization Himeji Medical Center, Hyogo, Japan; 5Moritera Eye Clinic, Shiga, Japan Purpose: To evaluate the surgical outcome of dacryocystorhinostomy (DCR by measuring the tear meniscus, using optical coherence tomography and rebamipide ophthalmic suspension. Methods: Patients with nasolacrimal obstruction and chronic dacryocystitis who were scheduled for an endonasal DCR underwent tear meniscus examinations before and 2 months after surgery. Vertical scans of the inferior menisci were performed before and at 1, 3, 5, 7, and 10 minutes after the instillation of rebamipide ophthalmic suspension. The tear menisci areas were measured with imaging software. Ten young adults without epiphora formed the control group.Results: Anatomical success was achieved on 22 sides of 21 patients. The patients’ postoperative tear menisci were significantly smaller than the preoperative menisci at all points during the test, and the response to volume loading in the postoperative patients was corrected to nearly that of the young, healthy adults. Nevertheless, the postoperative meniscus area tended to be larger than that of the young adults at all points.Conclusion: The reduced tear meniscus area after DCR reflected the success of the surgical procedure. However, incomplete recovery of the meniscus after the test might suggest a residual disorder of the lacrimal drainage system after DCR. Keywords: dacryocystorhinostomy, tear meniscus, rebamipide, optical coherence tomography

Herpes simplex virus ophthalmic disease induced using two different methods of mice inoculation

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Sílvia Regina Ferreira Gonçalves Pereira

Full Text Available Two different procedures for inoculation of HSV on corneas of BALB/c mice were evaluated. The first was by the use of HSV suspensions directly on the corneas and the other was after corneal scarification. Animals by this later method presented greater morbidity and mortality than those of first group, suggesting that inoculation of HSV without scarification of the cornea should be the method of choice for the study of HSV ophthalmic infection. This model showed also be an efficient experimental system to testing antiviral drugs.

Preparation and In Vitro/Ex Vivo Evaluation of Moxifloxacin-Loaded PLGA Nanosuspensions for Ophthalmic Application.

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Mudgil, Meetali; Pawar, Pravin K

2013-01-01

The aim of the present investigation was to prepare a colloidal ophthalmic formulation to improve the residence time of moxifloxacin. Moxifloxacin-loaded poly(dl-lactide-co-glycolide) (PLGA) nanosuspensions were prepared by using the solvent evaporation technique. The nanosuspensions were characterised physically by using different techniques like particle size, zeta potential, FTIR, DSC, and XRD analysis. In vitro and ex vivo studies of nanosuspensions were carried out using a modified USP dissolution apparatus and all-glass Franz diffusion cells, respectively. The antibacterial activities of the nanosuspension and marketed formulations were performed against S. aureus and P. aeroginosa. The moxifloxacin-loaded PLGA nanosuspensions showed uniform particle size, ranging between 164-490 nm with negative zeta potential for all batches. The percentage entrapment efficiency of the drug-loaded nano-suspension was found to be between 84.09 to 92.05%. In vitro drug release studies suggest that all of the formulations showed extended drug release profiles and follow Korsemeyer-Peppas release kinetics. In vitro corneal permeability was found to be comparable with that of the marketed formulation across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of moxifloxacin. The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.

Preparation and In Vitro/Ex Vivo Evaluation of Moxifloxacin-Loaded PLGA Nanosuspensions for Ophthalmic Application

OpenAIRE

MUDGIL, Meetali; PAWAR, Pravin

2013-01-01

The aim of the present investigation was to prepare a colloidal ophthalmic formulation to improve the residence time of moxifloxacin. Moxifloxacin-loaded poly(dl-lactide-co-glycolide) (PLGA) nanosuspensions were prepared by using the solvent evaporation technique. The nanosuspensions were characterised physically by using different techniques like particle size, zeta potential, FTIR, DSC, and XRD analysis. In vitro and ex vivo studies of nanosuspensions were carried out using a modified USP d...

JPEG and wavelet compression of ophthalmic images

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Eikelboom, Robert H.; Yogesan, Kanagasingam; Constable, Ian J.; Barry, Christopher J.

1999-05-01

This study was designed to determine the degree and methods of digital image compression to produce ophthalmic imags of sufficient quality for transmission and diagnosis. The photographs of 15 subjects, which inclined eyes with normal, subtle and distinct pathologies, were digitized to produce 1.54MB images and compressed to five different methods: (i) objectively by calculating the RMS error between the uncompressed and compressed images, (ii) semi-subjectively by assessing the visibility of blood vessels, and (iii) subjectively by asking a number of experienced observers to assess the images for quality and clinical interpretation. Results showed that as a function of compressed image size, wavelet compressed images produced less RMS error than JPEG compressed images. Blood vessel branching could be observed to a greater extent after Wavelet compression compared to JPEG compression produced better images then a JPEG compression for a given image size. Overall, it was shown that images had to be compressed to below 2.5 percent for JPEG and 1.7 percent for Wavelet compression before fine detail was lost, or when image quality was too poor to make a reliable diagnosis.

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model.

Science.gov (United States)

Petrov, Anton; Perekhvatova, Natalia; Skulachev, Maxim; Stein, Linda; Ousler, George

2016-01-01

This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms. In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day -7, Day 1, and Day 29). Investigator assessments occurred at all study visits. SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores. This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results. Clinicaltrials.gov identifier: NCT02121301. Miotech S.A.

Duration of IOP reduction with travoprost BAK-free solution.

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Gross, Ronald L; Peace, James H; Smith, Stephen E; Walters, Thomas R; Dubiner, Harvey B; Weiss, Mark J; Ochsner, Katherine I

2008-01-01

To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic solution 0.004% formulated with BAK (Travatan). This was a prospective, randomized, double-masked study. Patients with open-angle glaucoma or ocular hypertension were randomized to receive 2 weeks of once-daily therapy with travoprost BAK-free or travoprost with BAK. Patients received the last dose of medication on day 13 and then intraocular pressure (IOP) was assessed every 12 hours for 60 hours. Statistical analysis included change in IOP from baseline for each group and comparison of mean IOP between groups. Of the 109 patients enrolled, 106 patients completed the study. Untreated mean baseline IOP at 8 AM was 26.9 mm Hg in the travoprost BAK-free group and 27.1 mm Hg in the travoprost with BAK group. At 12, 24, 36, 48, and 60 hours after the last dose, mean IOP in the travoprost BAK-free group was 18.7, 17.2, 19.5, 18.7, and 20.8 mm Hg, respectively; whereas mean IOP in the travoprost with BAK group was 18.5, 16.8, 19.7, 18.0, and 20.8 mm Hg, respectively. Mean IOP at all time points after the last dose of medication was >6 mm Hg lower than the 8 AM baseline in both groups. Between-group differences were within +/-0.6 mm Hg at all postdose time points. There were no statistically significant differences between the 2 treatment groups at baseline or at any postdose time point. Drug-related side effects were uncommon, mild in intensity, and comparable between groups. Travoprost without BAK has similar IOP-lowering efficacy and safety compared with travoprost preserved with BAK. Both formulations of travoprost have a prolonged duration of action, with statistically and clinically significant reductions from baseline persisting up to 60 hours after the last dose.

Comparative Evaluation of Ultraviolet and Visible Light Transmittance through Prescriptive Ophthalmic Minus Lenses

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Mohammadreza Nazari

2014-06-01

Full Text Available Background: Wearing spectacles is the most common approach in correcting the refractive errors worldwide. Due to harmful effects of overexposure to solar ultraviolet radiations, the usage of multi-layer coatings in ophthalmic lenses has recently been increased. These lenses can reduce the reflections and hence increase the transmission of visible light; they can also decrease the transmission of ultraviolet rays. This study aims to compare the transmission of ultraviolet (A and B and visible rays through coated and uncoated prescriptive ophthalmic plastic lenses.Materials and Methods: In this study, 39 minus non-photochromic multi-coated white plastic single-vision lenses; 9 similar lenses but without any coatings were assessed by spectral transmittancemeter for evaluation of the transmission of visible and ultraviolet rays.Results: The transmission of visible light was 97.9%±1.07% for coated lenses and 93.5%±0.54% for lenses without coating. Ultraviolet-A transmission was 12.15%±8.02% for coated lenses compared to 66.27%±23.92% in lenses without coating. The transmission of ultraviolet-B rays was 1.21%±0.4% and 23.0%±15.97% for lenses with and without coatings, respectively.Conclusion: The transmission of visible light was significantly higher in multi-coated lenses compared to uncoated samples; whereas the transmissions of ultraviolet rays in multi-coated lenses were significantly lower than uncoated ones. Therefore, it is recommended that, except for particular cases, prescribed lenses be equipped with this multi-layer coating.

Comfort level of post graduate residents working in different clinical domains in managing common ophthalmic conditions

International Nuclear Information System (INIS)

Jaffar, S.; Tayyab, A.; Shah, S.S.; Naseem, S.; Ghazanfar, H.

2016-01-01

Background: Ophthalmological conditions are frequently encountered in almost all clinical specialties. Assessing the adequacy of ophthalmology teaching in undergraduate medical education is important in order to diagnose and manage different ophthalmological conditions. The objective of this study was to determine the comfort level of post graduate residents working in different clinical domains in managing common ophthalmic conditions. Methods: A cross sectional survey involving 277 post graduate residents was carried out over a period of six months in both private and public tertiary care hospital. A questionnaire containing two sections and 17 variables in total were distributed among Medical Residents of different specialties except ophthalmology residents. Participants of the study were selected through consecutive non probability sampling. Results: Mean hours of classroom based ophthalmology instruction during during undergraduate program was 59.38 hours (55.9) and mean hours of clinical based ophthalmology instruction during undergraduate program was 62.73 hours (60.8) 54 percentage were either not comfortable or somewhat comfortable in managing common ophthalmic condition. Conclusion: Teaching hours in under graduate program meet or exceed requisite criteria. However graduating doctors generally feel that the time spent does not provide them with the comfort and skill level required to care for patients with ocular presentations. (author)

Novel microemulsion in situ electrolyte-triggered gelling system for ophthalmic delivery of lipophilic cyclosporine A: in vitro and in vivo results.

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Gan, Li; Gan, Yong; Zhu, Chunliu; Zhang, Xinxin; Zhu, Jiabi

2009-01-05

The objective of the present study was to design a novel microemulsion in situ electrolyte-triggered gelling system for ophthalmic delivery of a lipophilic drug, cyclosporine A (CsA). A CsA-loaded microemulsion was prepared using castor oil, Solutol HS 15 (surfactant), glycerol and water. This microemulsion was then dispersed in a Kelcogel solution to form the final microemulsion in situ electrolyte-triggered gelling system. In vitro, the viscosity of the CsA microemulsion Kelcogel system increased dramatically on dilution with artificial tear fluid and exhibited pseudo-plastic rheology. In vivo results revealed that the AUC(0-->32 h) of corneal CsA for the microemulsion Kelcogel system was approximately three-fold greater than for a CsA emulsion. Moreover, at 32 h after administration, CsA concentrations delivered by the microemulsion Kelcogel system remained at therapeutic levels in the cornea. This CsA microemulsion in situ electrolyte-triggered gelling system might provide an alternative approach to deliver prolonged precorneal residence time of CsA for preventing cornea allograft rejection.

Ophthalmic patients' utilization of technology and social media: an assessment to improve quality of care.

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Aleo, Chelsea L; Hark, Lisa; Leiby, Benjamin; Dai, Yang; Murchison, Ann P; Martinez, Patricia; Haller, Julia A

2014-10-01

E-health tools have the potential to improve the quality of care for ophthalmic patients, many of whom have chronic conditions. However, little research has assessed ophthalmic patients' use or acceptance of technological devices and social media platforms for health-related purposes. The present study evaluated utilization of technological devices and social media platforms by eye clinic patients, as well as their willingness to receive health reminders through these technologies. A 31-item paper questionnaire was administered to eye clinic patients (n=843) at an urban, tertiary-care center. Questions focused on technology ownership, comfort levels, frequency of use, and preferences for receiving health reminders. Demographic data were also recorded. Eye clinic patients most commonly owned cellular phones (90%), landline phones (81%), and computers (80%). Overall, eye clinic patients preferred to receive health reminders through phone calls and e-mail and used these technologies frequently and with a high level of comfort. Less than 3% of patients preferred using social networking to receive health reminders. In addition, age was significantly associated with technology ownership, comfort level, and frequency of use (ptechnologies more frequently and with a higher comfort level (ptechnologies for appointment reminders, general eye and vision health information, asking urgent medical questions, and requesting prescription refills. Future controlled trials could further explore the efficacy of e-health tools for these purposes.

Cysteamine ophthalmic hydrogel for the treatment of ocular cystinosis

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Anxo Fernández-Ferreiro

2017-11-01

Full Text Available Ocular cystinosis is a rare disease characterised by the deposit of cystine crystals on the corneal surface, which hinder patients’ eyesight. Oral cysteamine is given as cysteamine; however, it does not reach the cornea due to the lack of corneal vascularization making necessary its administration by the topical ocular route. The aim of the present study is to determine the stability of an ophthalmic hydrogel of cysteamine, which can be potentially prepared at hospital pharmacy departments, under different preservation conditions during a follow-up of 30 days. Different physical and chemical parameters were evaluated: osmolality, pH and cysteamine concentration, which has been measured by a method of ultra performance liquid chromatography-tandem mass spectrometer (UPLC-MS/MS. Descriptive assays were also performed, such as transparency measurement and microbiological assays in order to verify its sterility. The obtained results allow us to conclude that the cysteamine hydrogel is stable during 30 days, being recommendable its preservation in refrigerated conditions.

A double-masked study to compare the efficacy and safety of topical cromolyn for the treatment of allergic conjunctivitis

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Yao-lin Liu

2011-11-01

Conclusion: Cromolyn 2 % ophthalmic solution was effective and safe to treat allergic conjunctivitis. A short-term use of cromolyn 2 % ophthalmic solution with 0.01% BAK would not cause any significant toxicity in patients with allergic conjunctivitis. Preservative-free cromolyn may be beneficial to the compromised eyes or eyes required of long-term medication.

Persistent dorsal ophthalmic artery arising from the internal carotid artery: Report of three cases

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Shin, Jae Hwan; Lee, Ghi Jai; Shim, Jae Chan; Lee, Kyoung Eun; Kim, Ho Kyun; Suh, Jung Ho [Dept. of Radiology, Seoul Paik Hospital, Inje University College of Medicine, Seoul (Korea, Republic of)

2016-12-15

Normally, the ophthalmic artery (OA) arises from the supraclinoid segment of the internal carotid artery (ICA) and enters the orbit via the optic canal. A persistent dorsal OA is a rare variation that originates from the cavernous segment of the ICA and enters the orbit via the superior orbital fissure. To the best of our knowledge, persistent dorsal OA has not been described in the Korean literature. In this paper, we report three cases of persistent dorsal OA with review of the literature on embryogenesis and other origins of the OA.

Patient adherence and persistence with topical ocular hypotensive therapy in real-world practice: a comparison of bimatoprost 0.01% and travoprost Z 0.004% ophthalmic solutions

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Campbell JH

2014-05-01

Full Text Available Joanna H Campbell,1 Gail F Schwartz,2 Britni LaBounty,3 Jonathan W Kowalski,1 Vaishali D Patel1 1Allergan, Inc., Irvine, CA, USA; 2Greater Baltimore Medical Center and Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA; 3Principled Strategies, Inc., Encinitas, CA, USA Background: Effective control of intraocular pressure is predicated upon patient compliance with pharmacotherapy. We compared patient adherence and persistence with two new ocular hypotensive formulations, using real-world utilization data. Methods: This observational cohort study employed pharmacy claims data from the Source® Lx (Wolters Kluwer Pharma Solutions database. Patients with an initial (index prescription for topical bimatoprost 0.01% or travoprost Z (April to June 2011 and no claim for ophthalmic prostaglandin or prostamide analogs within the previous 18 months were identified. Treatment adherence was expressed as proportion of days covered with study medication during the first 365 days after the index prescription. Treatment persistence with study medication was assessed over the first 12 months using Kaplan–Meier survival analyses, allowing a maximum 30-day gap for prescription refill. Treatment status was determined monthly over this period. Results: A total of 12,985 patients were assessed for treatment adherence, and 10,470 for treatment persistence. Adherence was better with bimatoprost 0.01% than with travoprost Z (mean proportion of days covered 0.540 versus [vs] 0.486, P<0.001, and more patients showed high adherence (proportion of days covered >0.80 with bimatoprost 0.01% than travoprost Z (29.1% vs 22.3%, P<0.001. Continuous 12-month persistence was higher with bimatoprost 0.01% than with travoprost Z (29.5% vs 24.2%, P<0.001. At month 12, more patients were on treatment with bimatoprost 0.01% than travoprost Z (48.8% vs 45.7%, P<0.01. Similar findings were demonstrated in cohorts of ocular hypotensive treatment-naïve patients, branded

The superior ophthalmic vein approach for the treatment of carotid-cavernous fistulas: our first experience

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Chiriac A.

2016-06-01

Full Text Available Complex cavernous sinus fistulae (CCF are still a technical challenge to neurovascular team. The most commonly performed treatment consists in endovascular embolization of the lesion through an arterial or venous approach. Not always these conventional routes are feasible, requiring alternative routes. We report a case of a 44-year-old woman with a complex indirect (Barrow D carotid cavernous sinus fistula treated by two interventional sessions that imposing a retrograde direct transvenous approach via the superior ophthalmic vein.

Formulation and development of ophthalmic in situ gel for the treatment ocular inflammation and infection using application of quality by design concept.

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Patel, Nirav; Thakkar, Vaishali; Metalia, Viral; Baldaniya, Lalji; Gandhi, Tejal; Gohel, Mukesh

2016-09-01

The conventional liquid ophthalmic delivery systems exhibit short pre-corneal residence time and the relative impermeability to the cornea which leads to poor ocular bioavailability. The aim of this study was to apply quality by design (QbD) for development of dexamethasone sodium phosphate (DSP) and tobramycin sulfate (TS)-loaded thermoresponsive ophthalmic in situ gel containing Poloxamer 407 and hydroxyl propyl methyl cellulose (HPMC) K4M for prolonging the pre-corneal residence time, ocular bioavability and decreases the frequency of administration of dosage form. The material attributes and the critical quality attributes (CQA) of the in situ gel were identified. Central composite design (CCD) was adopted to optimize the formulation. The ophthalmic in situ forming gels were prepared by cold method. Materials attributes were the amount of Poloxamer 407 and HPMC and CQA identified were Gel strength, mucoadhesive index, gelation temperature and % of drug release of both drug. Optimized batch (F*) containing 16.75% poloxamer 407 and 0.54% HPMC K4M were exhibited all results in acceptable limits. Compared with the marketed formulation, optimized in situ gel showed delayed Tmax, improved Cmax and AUC in rabbit aqueous humor, suggesting the sustained drug release and better corneal penetration and absorption. According to the study, it could be concluded that DSP and TS would be successfully formulated as in situ gelling mucoadhesive system for the treatment of steroid responsive eye infections with the properties of sustained drug release, prolonged ocular retention and improved corneal penetration.

Impact of digital imaging and communications in medicine workflow on the integration of patient demographics and ophthalmic test data.

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Pandit, Ravi R; Boland, Michael V

2015-02-01

To determine the impact of a Digital Imaging and Communications in Medicine (DICOM) workflow on the linkage of demographic information to ophthalmic testing data. Evaluation of technology. Six hundred ninety-nine visual field testing encounters performed by 6 ophthalmic technicians and the transfer error queue of 37 442 ophthalmic test results. At 3 months before and 6 and 18 months after implementation of a DICOM workflow, technicians recorded the work required to enter, confirm, or edit patient demographics in each visual field device. We also determined the proportion of imaging tests sent to an error queue for manual reconciliation because of incorrect demographic information before and 3, 6, and 18 months after the DICOM workflow was established. The proportion of testing encounters for which staff had to enter, edit, or merge patient demographics and the proportion of misfiled images. Staff entered, edited, or merged data for 48% of patients before implementation (n = 237). This decreased to 24% within 6 months and 20% within 18 months of implementing the DICOM archive (n = 230 and n = 232, respectively). Staff could locate a patient in a DICOM work list for 97% of encounters at 3 months and 99% at 18 months. Before implementation, 9.2% of the images required additional intervention to be associated with the correct patient (n = 3581). This decreased by 85% over 6 months to 1.4% (n = 9979; P workflow in an ophthalmology clinic reduced the need to enter or edit patient demographic information into imaging or testing devices by more than 50% and reduced the need to manage misfiled images by 76%. In a clinical environment that demands both efficiency and patient safety, the DICOM workflow is an important update to current practice. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

New developments in ophthalmic coatings on plastic lenses

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Eigenmann, H. P.; Lobsiger, W.; Suter, R.

1998-02-01

The origin of vision aids such as eyeglasses, magnifying glasses, telescopes and so forth lies in the distant past and cannot be dated with precision. However, such aids certainly came into use at different times in different cultures. Early portraits and other pictures prove to a certainty, however, that remarkable well-made spectacles were in use by the end of the Middle Ages. Glass was employed for optical lenses from the very beginning, and quality improved continuously with advances in glassmaking and polishing techniques. Starting around 1970, this continuing development received new impetus from the introduction of plastics as a new material for ophthalmic lenses. Rapid progress in plastics chemistry had epoch-making effects on lens technology, and today a wide variety of materials such as CR39, PMMA and polycarbonates, with refractive indices ranging from 1.52 to 1.65, are used for this purpose. Eyeglasses have long been important on other grounds than vision correction; people wear them as adornment, because they are fashionable, to express their personality, and for other reasons. This dramatic history shows no signs of coming to an end, and more innovations are definitely ahead.

Choosing wisely and the use of antibiotics in ophthalmic surgery: There is more than meets the eye.

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Grosso, Andrea; Ceruti, Piero; Scarpa, Giuseppe; Giardini, Franco; Marchini, Giorgio; Aragona, Emanuela; Bert, Fabrizio; Bandello, Francesco; Siliquini, Roberta

2018-02-01

One of the directions of modern ophthalmology is toward an odontoiatric model, and new settings of eye care are becoming the standard of care: one day surgery and also office-based therapies. Retrospective analysis of three tertiary-care centers in Italy and analysis of the literature. We provide readers with state-of-the-art measures of prophylaxis in ophthalmic surgery. Role of antibiotics is criticized in the light of stewardship antimicrobial paradigm.

Development of an Iridium-192 seed for use in ophthalmic brachytherapy

International Nuclear Information System (INIS)

Mattos, Fabio R.; Rostelato, Maria Elisa C.M.; Zeituni, Carlos; Moura, Joao A.; Costa, Osvaldo L.; Feher, Anselmo; Moura, Eduardo S.; Souza, Carla D.; Peleias Junior, Fernando S.

2011-01-01

The Institute for Energy and Nuclear Research (IPEN), in partnership with the School or Medicine (UNIFESP), created a project that aims to develop and implement an ophthalmic therapeutic treatment for cancer with Iridium-192 seeds. The School of Medicine treats many cancer cases in the SUS (Brazilian Public Health System), and brachytherapy group of IPEN has extensive experience in prototype sources. The seed to be manufactured will perform as follows: a core of Iridium-192 is packaged inside small cylindrical seeds consist of a titanium capsule of 0.8 mm outer diameter, 0.05 mm wall thickness and 4 5 mm in length. The core is an alloy of platinum-iridium (20/80) of 3.0 mm in length and 0.3 mm in diameter. Material analysis, neutron activation and activity measurements were carried out. (author)

Multimodal ophthalmic imaging using spectrally encoded scanning laser ophthalmoscopy and optical coherence tomography

Science.gov (United States)

El-Haddad, Mohamed T.; Malone, Joseph D.; Li, Jianwei D.; Bozic, Ivan; Arquitola, Amber M.; Joos, Karen M.; Patel, Shriji N.; Tao, Yuankai K.

2017-08-01

Ophthalmic surgery involves manipulation of delicate, layered tissue structures on milli- to micrometer scales. Traditional surgical microscopes provide an inherently two-dimensional view of the surgical field with limited depth perception which precludes accurate depth-resolved visualization of these tissue layers, and limits the development of novel surgical techniques. We demonstrate multimodal swept-source spectrally encoded scanning laser ophthalmoscopy and optical coherence tomography (SS-SESLO-OCT) to address current limitations of image-guided ophthalmic microsurgery. SS-SESLO-OCT provides inherently co-registered en face and cross-sectional field-of-views (FOVs) at a line rate of 400 kHz and >2 GPix/s throughput. We show in vivo imaging of the anterior segment and retinal fundus of a healthy volunteer, and preliminary results of multi-volumetric mosaicking for ultrawide-field retinal imaging with 90° FOV. Additionally, a scan-head was rapid-prototyped with a modular architecture which enabled integration of SS-SESLO-OCT with traditional surgical microscope and slit-lamp imaging optics. Ex vivo surgical maneuvers were simulated in cadaveric porcine eyes. The system throughput enabled volumetric acquisition at 10 volumes-per-second (vps) and allowed visualization of surgical dynamics in corneal sweeps, compressions, and dissections, and retinal sweeps, compressions, and elevations. SESLO en face images enabled simple real-time co-registration with the surgical microscope FOV, and OCT cross-sections provided depth-resolved visualization of instrument-tissue interactions. Finally, we demonstrate novel augmented-reality integration with the surgical view using segmentation overlays to aid surgical guidance. SS-SESLO-OCT may benefit clinical diagnostics by enabling aiming, registration, and mosaicking; and intraoperative imaging by allowing for real-time surgical feedback, instrument tracking, and overlays of computationally extracted biomarkers of disease.

Imaging of Unilateral Meningo-ophthalmic Artery Anomaly in a Patient with Bilateral Nasopharyngeal Angiofibroma

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Louise Louw

2014-01-01

Full Text Available A 12-year-old boy with epistaxis presented with a rare midline nasopharyngeal angiofibroma that extended lateral into the pterygoid and infratemporal fossae. Pre-operative angiography revealed bilateral prominent feeder arteries and two major anastomotic connections, and a rare left meningo-ophthalmic artery (M-OA anomaly that was the sole path of supply to the eye. A literature search using Pubmed and Medline was conducted. For imaging, a six-vessel study (i.e. external and internal carotid and vertebral arteries on both sides was selected. Embolization of prominent tumor feeder arteries was unsafe for tumor extirpation, but super-selective embolization of both sphenopalatine arteries was performed to control epistaxis. The M-OA anomaly that originated from the maxillary artery (MA was marked by an ophthalmic artery (OA variant with orbital and ocular divisions that coursed through the superior orbital fissure and optic foramen, respectively, each with distinct branching patterns, a middle meningeal artery (MMA with normal branches (i.e. anterior and posterior branches, and two branch variations (i.e. lacrimal and meningeal branches that originated from the anterior branch of the MMA. The lacrimal branch coursed through a cranio-orbital foramen, but the meningeal branch remained outside the orbit. The anatomy of the right OA was normal. The left M-OA anomaly was considered incidental and not tumor-related since the tumor was more prominent on the right side, and no intra-orbital infiltrations occurred. Of clinical significance is that proximal embolization of MA or MMA carries a high risk of visual impairment in cases where M-OA anomalies are the sole mode of supply to the eye.

Ophthalmic diagnostic tests, orbital anatomy, and adnexal histology of the broad-snouted caiman (Caiman latirostris).

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Oriá, Arianne P; Oliveira, Alberto Vinícius D; Pinna, Melissa H; Martins Filho, Emanoel F; Estrela-Lima, Alessandra; Peixoto, Tiago C; Silva, Renata Maria M da; Santana, Fernanda O; Meneses, Íris Daniela S; Requião, Kátia G; Ofri, Ron

2015-01-01

The aim of this study was to establish normal ophthalmic parameters for selected diagnostic tests, and to describe the orbital anatomy and adnexal histology of the broad-snouted caiman. A total of 35 Caiman latirostris that were free of obvious ocular diseases were used to measure the parameters in this investigation. Ages ranged from 5 to 15 years. Ophthalmic diagnostic tests were conducted, including evaluation of tear production with Schirmer Tear test-1 (STT1), culture of the conjunctival bacterial flora, applanation tonometry, conjunctival cytology, nictiating membrane incursion frequency test (NMIFT), endodontic absorbent paper point tear test (EAPPTT), palpebral fissure length measurement (PFL) and B-mode ultrasonography. Adnexal histology and skull samples were studied. Mean (±SD) STT1 was 3.4 ± 3.6 mm/min (95% confidence interval of 2.01-4.78 mm/min), intraocular pressure (IOP) was 12.9 ± 6.2 mmHg, NMIFT was 6.0 ± 3.5, EAPPTT was 17.1 ± 2.5 mm/min, PFL was 28.9 ± 3.0 mm, anterior chamber depth was 3.1 ± 0.3 mm, lens axial length was 8.4 ± 0.6 mm, vitreous chamber depth was 7.9 ± 0.7 mm and axial globe length was 19.9 ± 1.3 mm. For all animals evaluated, Bacillus sp., Diphteroids and Staphylococcus sp. were predominant. © 2013 American College of Veterinary Ophthalmologists.

Brachytherapy, diagnostic radiology, mammographic radiology and ophthalmic applicators. An assessment of current and future needs in the UK and the role of NPL

International Nuclear Information System (INIS)

Angliss, R.; Bass, G.; Sander, T.

2001-01-01

Several UK hospitals were visited by NPL staff to discuss the current practises and future developments in brachytherapy, diagnostic and mammographic radiology and ophthalmic applicators. The results of the discussions are presented here, including NPL's role in each of these areas is discussed. (author)

Epigenetic Treatment of Neurodegenerative Ophthalmic Disorders: An Eye Toward the Future.

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Moos, Walter H; Faller, Douglas V; Glavas, Ioannis P; Harpp, David N; Irwin, Michael H; Kanara, Iphigenia; Pinkert, Carl A; Powers, Whitney R; Steliou, Kosta; Vavvas, Demetrios G; Kodukula, Krishna

2017-01-01

Eye disease is one of the primary medical conditions that requires attention and therapeutic intervention in ageing populations worldwide. Further, the global burden of diabetes and obesity, along with heart disease, all lead to secondary manifestations of ophthalmic distress. Therefore, there is increased interest in developing innovative new approaches that target various mechanisms and sequelae driving conditions that result in adverse vision. The research challenge is even greater given that the terrain of eye diseases is difficult to landscape into a single therapeutic theme. This report addresses the burden of eye disease due to mitochondrial dysfunction, including antioxidant, autophagic, epigenetic, mitophagic, and other cellular processes that modulate the biomedical end result. In this light, we single out lipoic acid as a potent known natural activator of these pathways, along with alternative and potentially more effective conjugates, which together harness the necessary potency, specificity, and biodistribution parameters required for improved therapeutic outcomes.

[Cysteamine ophthalmic hydrogel for the treatment of ocular cystinosis].

Science.gov (United States)

Fernández-Ferreiro, Anxo; Luaces-Rodríguez, Andrea; Díaz-Tomé, Victoria; Gil-Martínez, María; Rodríguez Ares, María Teresa; Touriño Peralba, Rosario; Blanco-Méndez, José; González-Barcia, Miguel; Otero-Espinar, Francisco Javier; Lamas, María Jesús

2017-11-01

Ocular cystinosis is a rare disease characterised by the deposit of cystine crystals on the corneal surface, which hinder patients' eyesight. Oral cysteamine is given as cysteamine; however, it does not reach the cornea due to the lack of corneal vascularization making necessary its  administration by the topical ocular route. The aim of the present study is to  determine the stability of an ophthalmic hydrogel of cysteamine, which can be  potentially prepared at hospital pharmacy departments, under different preservation conditions during a follow-up of 30 days. Different physical  and chemical parameters were evaluated: osmolality, pH and  cysteamine concentration, which has been measured by a method of ultra  performance liquid chromatography-tandem mass spectrometer (UPLC-MS/MS).  Descriptive assays were also performed, such as transparency measurement and  microbiological assays in order to verify its sterility. The obtained results  allow us to conclude that the cysteamine hydrogel is stable during 30 days,  being recommendable its preservation in refrigerated conditions. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Patterns of ophthalmic emergencies presenting to a referral hospital in Medina City, Saudi Arabia

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Omar M. Alabbasi

2017-10-01

Full Text Available Background: Data are required on ophthalmic cases that present to the emergency eye clinics in Madinah, Saudi Arabia for proper allocation of healthcare resources. Objectives: To determine the frequency and various diagnoses of patients presenting to the A&E at Ohud Hospital, Madinah, Saudi Arabia. Methods: Data was collected prospectively for all patients who presented to the A&E ophthalmology clinic from June 2014 to September 2014. The data was analyzed and presented using frequency of incidence and percentages. Chi-square tests were used to evaluate the diagnoses based on age, sex and nationality. P ≤ 0.05 indicated statistical significance. Results: The study sample included 868 patients. The male-to-female ratio was 1.1:1.0. The main age categories included patients ≥45 years of age (256 patients and 251 patients between the ages of 15–30 years. Various types of Conjunctivitis was the most common diagnosis, reported in 282 patients (32.5%, and followed by dry eye syndrome in 156 (18% patients. Nasolacrimal duct obstruction in 156 patients (18%. Eyelid infections were detected in 102 patients (12%, corneal abrasion in 102 patients (9.3%. Various eye traumas was diagnosed in 30 patients (3.5%, increased intraocular pressure (IOP in 17 patients (2%, ruptured globe in 2 patients (0.2% and various other non-emergency pathologies in the remaining eyes. There were no significant differences in patient’s characteristics and categories of diagnoses. Conclusion: Non-emergent ophthalmic cases were the most common reason for the ophthalmology emergency room visits. It was observed that most cases could be referred to outpatient departments and potentially be managed by primary healthcare providers. This would be more cost effective and will also allow for better management of vision threatening ocular emergencies.

A fluid-structure interaction model of the internal carotid and ophthalmic arteries for the noninvasive intracranial pressure measurement method.

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Misiulis, Edgaras; Džiugys, Algis; Navakas, Robertas; Striūgas, Nerijus

2017-05-01

Accurate and clinically safe measurements of intracranial pressure (ICP) are crucial for secondary brain damage prevention. There are two methods of ICP measurement: invasive and noninvasive. Invasive methods are clinically unsafe; therefore, safer noninvasive methods are being developed. One of the noninvasive ICP measurement methods implements the balance principle, which assumes that if the velocity of blood flow in both ophthalmic artery segments - the intracranial (IOA) and extracranial (EOA) - is equal, then the acting ICP on the IOA and the external pressure (Pe) on the EOA are also equal. To investigate the assumption of the balance principle, a generalized computational model incorporating a fluid-structure interaction (FSI) module was created and used to simulate noninvasive ICP measurement by accounting for the time-dependent behavior of the elastic internal carotid (ICA) and ophthalmic (OA) arteries and their interaction with pulsatile blood flow. It was found that the extra balance pressure term, which incorporates the hydrodynamic pressure drop between measurement points, must be added into the balance equation, and the corrections on a difference between the velocity of blood flow in the IOA and EOA must be made, due to a difference in the blood flow rate. Copyright © 2017 Elsevier Ltd. All rights reserved.

WE-DE-201-05: Evaluation of a Windowless Extrapolation Chamber Design and Monte Carlo Based Corrections for the Calibration of Ophthalmic Applicators

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Hansen, J; Culberson, W; DeWerd, L [University of Wisconsin Medical Radiation Research Center, Madison, WI (United States); Soares, C [NIST (retired), Gaithersburg, MD (United States)

2016-06-15

Purpose: To test the validity of a windowless extrapolation chamber used to measure surface dose rate from planar ophthalmic applicators and to compare different Monte Carlo based codes for deriving correction factors. Methods: Dose rate measurements were performed using a windowless, planar extrapolation chamber with a {sup 90}Sr/{sup 90}Y Tracerlab RA-1 ophthalmic applicator previously calibrated at the National Institute of Standards and Technology (NIST). Capacitance measurements were performed to estimate the initial air gap width between the source face and collecting electrode. Current was measured as a function of air gap, and Bragg-Gray cavity theory was used to calculate the absorbed dose rate to water. To determine correction factors for backscatter, divergence, and attenuation from the Mylar entrance window found in the NIST extrapolation chamber, both EGSnrc Monte Carlo user code and Monte Carlo N-Particle Transport Code (MCNP) were utilized. Simulation results were compared with experimental current readings from the windowless extrapolation chamber as a function of air gap. Additionally, measured dose rate values were compared with the expected result from the NIST source calibration to test the validity of the windowless chamber design. Results: Better agreement was seen between EGSnrc simulated dose results and experimental current readings at very small air gaps (<100 µm) for the windowless extrapolation chamber, while MCNP results demonstrated divergence at these small gap widths. Three separate dose rate measurements were performed with the RA-1 applicator. The average observed difference from the expected result based on the NIST calibration was −1.88% with a statistical standard deviation of 0.39% (k=1). Conclusion: EGSnrc user code will be used during future work to derive correction factors for extrapolation chamber measurements. Additionally, experiment results suggest that an entrance window is not needed in order for an extrapolation

Ocular findings and reference values for selected ophthalmic diagnostic tests in the macaroni penguin (Eudyptes chrysolophus) and southern rockhopper penguin (Eudyptes chrysocome).

Science.gov (United States)

Bliss, Cassandra D; Aquino, Susette; Woodhouse, Sarah

2015-01-01

To describe ophthalmic examination findings and standard diagnostic test results in 2 penguin species. Macaroni & Southern Rockhopper Penguins. Complete ophthalmic examinations including Schirmer tear test (STT), modified phenol red thread test (PTT), tonometry, and echobiometry were performed on penguins housed at the Detroit Zoo. Mean and standard deviation of ophthalmic tests are reported and compared for significance using two sample t-tests with significance set at P Penguins, and 68% of Rockhopper Penguins. There were anterior segment anomalies in all eyes with cataracts consistent with lens-induced uveitis. The mean modified PTT for the Macaronis was 24.7 ± 6.37 mm/15 s and 25.1 ± 7.07 mm/15 s in the Rockhoppers. The mean STT value for the Macaronis was 12.1 ± 5.43 mm/min and 11.0 ± 3.96 mm/min in the Rockhoppers. Mean intraocular pressure (IOP) for the Macaronis was 21.9 ± 7.05 mmHg measured by applanation tonometry and 29.1 ± 7.16 mmHg using rebound tonometry. The Rockhoppers had a mean IOP of 20.0 ± 5.77 mmHg and 24.1 ± 5.09 mmHg for applanation and rebound tonometry, respectively. In both populations, there was a significant difference in IOP measurement between the two instruments. In the Macaroni penguins, the presence of cataracts correlated significantly with increased age and lower IOP readings. Anterior chamber distance and axial globe length were significantly greater in males than in females in both penguin species. © 2013 American College of Veterinary Ophthalmologists.

Shortcomings of the industrial quality assurance of {sup 106}Ru ophthalmic plaques; Therapierelevante Schwachstellen bei der industriellen Qualitaetssicherung von {sup 106}Ru-Augenapplikatoren

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Kaulich, T.W.; Nuesslin, F. [Universitaetsklinik fuer Radioonkologie, Tuebingen (Germany). Abt. Medizinische Physik; Zurheide, J. [BrainLAB AG, Heimstetten (Germany); Fluehs, D. [Abt. Strahlentherapie, Bereich klinische Strahlenphysik, Universitaetsklinikum Essen (Germany); Haug, T. [Isotopenlabor der Univ. Tuebingen (Germany); Bamberg, M. [Abt. Radioonkologie, Universitaetsklinik fuer Radioonkologie, Tuebingen (Germany)

2001-11-01

Background: Beta emitting {sup 106}Ru applicators manufactured by Bebig GmbH (Berlin, Germany) are widely used to treat intraocular tumors. The applicators are fixed to the bulbus and removed after several days. The following therapy relevant defects have been detected by an internal clinical acceptance test: risk of leakage and inconsistent dose-rate specifications by the manufacturer. In the meantime, components of the internal clinical acceptance test have been adopted successfully by the manufacturer of the {sup 106}Ru ophthalmic plaques. Material and Method: {sup 106}Ru ophthalmic plaques were tested with the following internal clinical acceptance tests: visual inspection, surface contamination, leakage, and dose-rate verification. The surface contamination test consists of a wet wipe test at moderate pressure. For the leakage test of the {sup 106}Ru ophthalmic plaques a clinically relevant scenario was developed in which the contact of the applicator with human tissue is simulated. In the course of it the applicator is inserted into Ringer's solution for several days. The certified energy dose-rate statements of the manufacturer are examined with a 1 mm{sup 3} plastic scintillator for consistency. (orig.) [German] Hintergrund: {sup 106}Ru-Augenapplikatoren der Fa. Bebig (Berlin) werden zur strahlentherapeutischen Behandlung von intraokularen Tumoren eingesetzt. Die Applikatoren werden sklerakontaktierend am Bulbus fixiert und nach mehreren Tagen wieder entfernt. Durch eine klinikinterne Eingangspruefung wurden folgende therapierelevante Maengel bei den Augenapplikatoren entdeckt: mangelhafte Dichtheit und inkonsistente Dosisleistungsangaben des Herstellers. Ein Teil dieser klinikinternen Eingangspruefung wurde inzwischen vom Hersteller der {sup 106}Ru-Augenapplikatoren uebernommen und erfolgreich eingesetzt. Material und Methode: Es wurden {sup 106}Ru-Augenapplikatoren durch folgende klinikinterne Eingangspruefungen getestet: optische Inspektion

A method for the calibration of concave 90Sr+90Y ophthalmic applicators

International Nuclear Information System (INIS)

Soares, C.G.

1992-01-01

At the Amersham Laboratory (Amersham, UK) absorbed-dose rate in tissue at a depth of 7 mg cm -2 from curved ophthalmic applicators is measured with calibrated scintillator probes (Amersham International 1979, Sinclair and Trott 1956). The probes are approximately 3 mm in diameter, 0.5 mm thick and are covered with 7 mg cm -2 of aluminium. They are calibrated using standard sources whose dose rate has been determined using an extrapolation chamber equipped with a 3 mm diameter collecting electrode. Crucial to this technique is the availability of well calibrated sources of nearly the same geometry and dose rate as the source to be calibrated. A technique is presented here which yields accurate measurement of the surface absorbed-dose rate in a very simple and straightforward fashion. (author)

A curious fact: Photic sneeze reflex. Autosomical dominant compelling helio-ophthalmic outburst syndrome.

Science.gov (United States)

Sevillano, C; Parafita-Fernández, A; Rodriguez-Lopez, V; Sampil, M; Moraña, N; Viso, E; Cores, F J

2016-07-01

To assess ocular involvement in the pathophysiology of autosomal dominant compelling helio-ophthalmic outburst syndrome (ACHOOs). An interview was conducted with a Caucasian family that showed clinical features of ACHOOs. Twelve of them had photic reflex and were recruited. A complete eye evaluation was made. A dominant autosomal inheritance with mild penetrance was demonstrated, with 67% of the studied subjects showing some degree of prominent corneal nerves. No other eye changes were found. Prominent corneal nerves may be associated with ACHOOs. The other eye structures studied do not seem to play a role in ACHOOs. Further studies are needed to understand the physiology of the ACHOOs. Copyright © 2016 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

Profiling extractable and leachable inorganic impurities in ophthalmic drug containers by ICP-MS.

Science.gov (United States)

Solomon, Paige; Nelson, Jenny

2018-03-01

In this study, we investigated the elemental impurities present in the plastic material of ophthalmic eye drop bottles using inductively coupled plasma-mass spectrometry (ICP-MS). Metallic contaminations, especially localized within the small cavity of the eye, can significantly perturb the ocular metallome. The concern is two-fold: first certain elements, for example heavy metals, can be toxic to humans at even trace levels, and second, these contaminations can have adverse reactions with other medicines or enzymatic processes in the eye. The implication of redox-active metals in cataract formation is one such biological consequence. The analysis demonstrated the effect of aggressive storage and transportation conditions on elemental extractable and leachable contamination, and posits that release of these elemental impurities can disrupt metallome equilibrium in the ocular compartment, leading to toxicity and disease.

Changes in Ocular Surface Characteristics after Switching from Benzalkonium Chloride-Preserved Latanoprost to Preservative-Free Tafluprost or Benzalkonium Chloride-Preserved Tafluprost

OpenAIRE

Tokuda, Naoto; Kitaoka, Yasushi; Matsuzawa, Akiko; Tsukamoto, Ayaka; Sase, Kana; Sakae, Shinsuke; Takagi, Hitoshi

2017-01-01

Purpose. The aim of the present study was to examine the effects of switching from Latanoprost ophthalmic solution containing a preservative to preservative-free Tafluprost ophthalmic solution or Tafluprost containing a preservative on ocular surfaces. Materials and Methods. Forty patients (40 eyes) with glaucoma (mean age: 62.0 ± 10.9 years) using Latanoprost with preservative for six months or longer were assigned either to a Tafluprost-containing-preservative group (20 eyes) or preservativ...

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).

Science.gov (United States)

Paskiet, Diane; Jenke, Dennis; Ball, Douglas; Houston, Christopher; Norwood, Daniel L; Markovic, Ingrid

2013-01-01

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The collaborative activities of PQRI participants have, in the case of orally inhaled and nasal drug products (OINDPs), resulted in comprehensive and widely-accepted recommendations for leachables assessments to help ensure patient safety with respect to this class of packaged drug products. These recommendations, which include scientifically justified safety thresholds for leachables, represent a significant milestone towards establishing standardized approaches for safety qualification of leachables in OINDP. To build on the success of the OINDP effort, PQRI's Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group was formed to extrapolate the OINDP threshold concepts and best practice recommendations to other dosage forms with high concern for interaction with packaging/delivery systems. This article considers the general aspects of leachables and their safety assessment, introduces the PODP Work Plan and initial study Protocol, discusses the laboratory studies being conducted by the PODP Chemistry Team, outlines the strategy being developed by the PODP Toxicology Team for the safety qualification of PODP leachables, and considers the issues associated with application of the safety thresholds, particularly with respect to large-volume parenterals. Lastly, the unique leachables issues associated with biologics are described. The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia, and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Orally Inhaled and Nasal Drug Products Leachables and Extractables Working Group resulted in a

Ophthalmic Manifestations of Xeroderma Pigmentosum: A Perspective from the United Kingdom.

Science.gov (United States)

Lim, Rongxuan; Sethi, Mieran; Morley, Ana M S

2017-11-01

To document the ocular manifestations of xeroderma pigmentosum (XP), presenting via the United Kingdom (UK) XP service, and to analyze the correlations between XP genotype and ophthalmic phenotype. Prospective observational case series. Eighty-nine patients seen by the UK Nationally Commissioned XP Service, from April 2010 to December 2014, with a genetically confirmed diagnosis of XP. Patients underwent a full ophthalmic examination at each visit. Clinical features from both eyes were recorded on a standard proforma. The most recent assessments were analyzed. A 2-tailed Fisher exact test was used to assess for differences in ocular features between patients in XP subgroups with impaired transcription coupled nucleotide excision repair (TC-NER) (category 1: XP-A, B, D, F, and G) and preserved TC-NER (category 2: XP-C, E, and V). Lid and periocular abnormalities, ocular surface pathologies, neuro-ophthalmologic abnormalities, lens and retinal abnormalities, and visual acuity (VA). Ninety-three percent of XP patients in our cohort had ocular involvement, with 65% describing photophobia. The most common abnormalities were in the periocular skin and ocular surface, including interpalpebral conjunctival melanosis (44%) and conjunctival injection (43%). Eleven percent of patients had required treatment for periocular cancers and 2% for ocular surface cancers. The most common neuro-ophthalmologic finding was minimal pupillary reaction to light (25%). Patients in category 2 had significantly more ocular surface abnormalities than patients in category 1, including a greater proportion of conjunctival injection (P = 0.003), conjunctival corkscrew vessels (P < 0.001), corneal scarring (P = 0.01) and pingueculae under the age of 50 (P = 0.02). Meanwhile, patients in category 1 had a higher proportion of poorly reactive pupils (P < 0.001) and abnormal ocular movements (P = 0.03) compared with those in category 2. Five patients (6%) presented to ophthalmologists with ocular

Effect of topical ophthalmic epinastine and olopatadine on tear volume in mice.

Science.gov (United States)

Villareal, Arturo L; Farley, William; Pflugfelder, Stephen C

2006-12-01

To investigate the effects of topical epinastine and olopatadine on tear volume by using a mouse model. Eighty-five C57BL6 mice (170 eyes) were treated twice daily with topical ophthalmic epinastine 0.05%, olopatadine 0.1%, or atropine 1% or served as untreated controls. A thread-wetting assay was used to measure tear volume at baseline and 15, 45, 90, 120, and 240 minutes after the last instillation of the drug on days 2 and 4 of treatment. After 2 days of treatment, epinastine-treated mice showed greater mean tear volumes than olopatadine-treated mice did at 15, 45, 90, and 240 minutes, with statistical significance at 15 and 45 minutes (Placrimal functional unit, epinastine may be an especially good choice for the treatment of allergic conjunctivitis in patients with dry eye disease or in those who are at risk for developing dry eye.

N-Butyl Cyanoacrylate Proved Beneficial to Avoid a Nontarget Embolization of the Ophthalmic Artery in Endovascular Management of Epistaxis

Science.gov (United States)

Shuster, A.; Gunnarsson, T.; Klurfan, P.; Larrazabal, R.

2011-01-01

Summary Epistaxis is a common disorder affecting equally both genders. Posterior origin of epistaxis in some instances requires endovascular treatment. Anastomoses between external carotid artery and internal carotid or ophthalmic arteries heighten the risk of stroke or blindness, if particles of polyvinyl alcohol are used for embolization. We report a case of 90-year-old man for whom successful embolization with N-Butyl Cyanoacrylate glue was performed as an alternative treatment for recurrent epistaxis. PMID:21561554

Pituitary Dysfunction from an Unruptured Ophthalmic Internal Carotid Artery Aneurysm with Improved 2-year Follow-up Results: A Case Report.

Science.gov (United States)

Qi, Meng; Ye, Ming; Li, Meng; Zhang, Peng

2018-01-01

Internal carotid artery (ICA) supraclinoid segment aneurysms extending into the sellar region and leading to pituitary dysfunction are a rare occurrence. To date, long-term follow up of pituitary function 2 years post-treatment has never been reported. Herein, we present a case of pituitary dysfunction due to an unruptured ophthalmic segment internal carotid artery aneurysm and report improved 2-year follow-up results. A 76-year-old male presented with disturbed consciousness due to hyponatremia, which was caused by hypoadrenocorticism resulting from pituitary dysfunction complicated by hypogonadism and hypothyroidism. Computed tomography angiography revealed an intracranial aneurysm of the ophthalmic segment of the right ICA with an intrasellar extension. Thus, digital subtraction angiography and coil embolization were performed, followed by hormone replacement therapy. A 2-year follow-up revealed a partial improvement in the pituitary function, including complete restoration of thyroid-stimulating hormone level and other thyroid hormones levels, and partial restoration of testosterone levels, followed by discontinuation of thyroid hormone replacement therapy. However, the mechanisms of such pituitary dysfunction and the effects of various treatments, including clipping and coiling, on different hormones of pituitary function recovery remain unclear. A long-term follow-up of >2 years may elucidate the pituitary function recovery post-treatment and provide a medication adjustment for hormone replacement therapy.

Are ultrasound-guided ophthalmic blocks injurious to the eye? A comparative rabbit model study of two ultrasound devices evaluating intraorbital thermal and structural changes.

Science.gov (United States)

Palte, Howard D; Gayer, Steven; Arrieta, Esdras; Scot Shaw, Eric; Nose, Izuru; Lee, Elizabete; Arheart, Kristopher L; Dubovy, Sander; Birnbach, David J; Parel, Jean-Marie

2012-07-01

Since Atkinson's original description of retrobulbar block in 1936, needle-based anesthetic techniques have become integral to ophthalmic anesthesia. These techniques are unfortunately associated with rare, grave complications such as globe perforation. Ultrasound has gained widespread acceptance for peripheral nerve blockade, but its translation to ocular anesthesia has been hampered because sonic energy, in the guise of thermal or biomechanical insult, is potentially injurious to vulnerable eye tissue. The US Food and Drug Administration (FDA) has defined guidelines for safe use of ultrasound for ophthalmic examination, but most ultrasound devices used by anesthesiologists are not FDA-approved for ocular application because they generate excessive energy. Regulating agencies state that ultrasound examinations can be safely undertaken as long as tissue temperatures do not increase >1.5°C above physiological levels. Using a rabbit model, we investigated the thermal and mechanical ocular effects after prolonged ultrasonic exposure to single orbital- and nonorbital-rated devices. In a dual-phase study, aimed at detecting ocular injury, the eyes of 8 rabbits were exposed to continuous 10-minute ultrasound examinations from 2 devices: (1) the Sonosite Micromaxx (nonorbital rated) and (2) the Sonomed VuMax (orbital rated) machines. In phase I, temperatures were continuously monitored via thermocouples implanted within specific eye structures (n = 4). In phase II the eyes were subjected to ultrasonic exposure without surgical intervention (n = 4). All eyes underwent light microscopy examinations, followed at different intervals by histology evaluations conducted by an ophthalmic pathologist. Temperature changes were monitored in the eyes of 4 rabbits. The nonorbital-rated transducer produced increases in ocular tissue temperature that surpassed the safe limit (increases >1.5°C) in the lens of 3 rabbits (at 5.0, 5.5, and 1.5 minutes) and cornea of 2 rabbits (both at 1

A New Generation Fiber Optic Probe: Characterization of Biological Fluids, Protein Crystals and Ophthalmic Diseases

Science.gov (United States)

Ansari, Rafat R.; Suh, Kwang I.

1996-01-01

A new fiber optic probe developed for determining transport properties of sub-micron particles in fluids experiments in a microgravity environment has been applied to characterize particulate dispersions/suspensions in various challenging environments which have been hitherto impossible. The probe positioned in front of a sample delivers a low power light (few nW - 3mW) from a laser and guides the light which is back scattered by the suspended particles through a receiving optical fiber to a photo detector and to a digital correlator. The probe provides rapid determination of macromolecular diffusivities and their respective size distributions. It has been applied to characterize various biological fluids, protein crystals, and ophthalmic diseases.

Automatic segmentation of closed-contour features in ophthalmic images using graph theory and dynamic programming

Science.gov (United States)

Chiu, Stephanie J.; Toth, Cynthia A.; Bowes Rickman, Catherine; Izatt, Joseph A.; Farsiu, Sina

2012-01-01

This paper presents a generalized framework for segmenting closed-contour anatomical and pathological features using graph theory and dynamic programming (GTDP). More specifically, the GTDP method previously developed for quantifying retinal and corneal layer thicknesses is extended to segment objects such as cells and cysts. The presented technique relies on a transform that maps closed-contour features in the Cartesian domain into lines in the quasi-polar domain. The features of interest are then segmented as layers via GTDP. Application of this method to segment closed-contour features in several ophthalmic image types is shown. Quantitative validation experiments for retinal pigmented epithelium cell segmentation in confocal fluorescence microscopy images attests to the accuracy of the presented technique. PMID:22567602

Survey of ophthalmic anterior segment findings and intraocular pressure in 95 North American box turtles (Terrapene spp.).

Science.gov (United States)

Espinheira Gomes, Filipe; Brandão, João; Sumner, Julia; Kearney, Michael; Freitas, Inês; Johnson, James; Cutler, Daniel; Nevarez, Javier

2016-03-01

To describe the ophthalmic biomicroscopy findings and intraocular pressures (IOP) in a captive population of box turtles and to determine whether a relationship exists between body morphometrics or health status and IOP. Hundred and three box turtles (69 Gulf coast, 24 three-toed, one ornate, one eastern, and eight unidentified) were triaged into three different color-coded groups: green (healthy), yellow (abnormal physical examination with no need for immediate care), and red (immediate care required). Both eyes were evaluated by rebound tonometry and slit-lamp biomicroscopy. Body weight and morphometric data were recorded. Intraocular pressures measurements were available for 190 eyes, slit-lamp biomicroscopy was available for 170 eyes, and morphometric data were available for 81 turtles. IOP in Gulf coast turtles (138 eyes) was 6.7 ± 1.4 mmHg OU. IOP in three-toed turtles (48 eyes) was 8.3 ± 1.5 mmHg OU, which was significantly higher than in Gulf coast turtles (P turtles only. There was a mild negative correlation between morphometrics and IOP in Gulf coast and three-toed turtles. Fifteen of 87 turtles had unilateral corneal or lenticular opacities; 3/87 had bilateral corneal or lenticular disease; and 3/87 had adnexal abnormalities. Different subspecies of box turtles have different normal intraocular pressures as measured by rebound tonometry, which was influenced by the animals' health status in one subspecies. Some morphometric parameters were found to be associated with IOP. Box turtles are often affected with ophthalmic abnormalities of unknown clinical significance. © 2015 American College of Veterinary Ophthalmologists.

Liquid Crystalline Nanoparticles as an Ophthalmic Delivery System for Tetrandrine: Development, Characterization, and In Vitro and In Vivo Evaluation

Science.gov (United States)

Liu, Rui; Wang, Shuangshuang; Fang, Shiming; Wang, Jialu; Chen, Jingjing; Huang, Xingguo; He, Xin; Liu, Changxiao

2016-05-01

The purpose of this study was to develop novel liquid crystalline nanoparticles (LCNPs) that display improved pre-ocular residence time and ocular bioavailability and that can be used as an ophthalmic delivery system for tetrandrine (TET). The delivery system consisted of three primary components, including glyceryl monoolein, poloxamer 407, and water, and two secondary components, including Gelucire 44/14 and amphipathic octadecyl-quaternized carboxymethyl chitosan. The amount of TET, the amount of glyceryl monoolein, and the ratio of poloxamer 407 to glyceryl monoolein were selected as the factors that were used to optimize the dependent variables, which included encapsulation efficiency and drug loading. A three-factor, five-level central composite design was constructed to optimize the formulation. TET-loaded LCNPs (TET-LCNPs) were characterized to determine their particle size, zeta potential, entrapment efficiency, drug loading capacity, particle morphology, inner crystalline structure, and in vitro drug release profile. Corneal permeation in excised rabbit corneas was evaluated. Pre-ocular retention was determined using a noninvasive fluorescence imaging system. Finally, pharmacokinetic study in the aqueous humor was performed by microdialysis technique. The optimal formulation had a mean particle size of 170.0 ± 13.34 nm, a homogeneous distribution with polydispersity index of 0.166 ± 0.02, a positive surface charge with a zeta potential of 29.3 ± 1.25 mV, a high entrapment efficiency of 95.46 ± 4.13 %, and a drug loading rate of 1.63 ± 0.07 %. Transmission electron microscopy showed spherical particles that had smooth surfaces. Small-angle X-ray scattering profiles revealed an inverted hexagonal phase. The in vitro release assays showed a sustained drug release profile. A corneal permeation study showed that the apparent permeability coefficient of the optimal formulation was 2.03-fold higher than that of the TET solution. Pre-ocular retention

Traditional eye medicine use by newly presenting ophthalmic patients to a teaching hospital in south-eastern Nigeria: socio-demographic and clinical correlates

Directory of Open Access Journals (Sweden)

Uche Judith

2009-10-01

Full Text Available Abstract Background This study set out to determine the incidence, socio-demographic, and clinical correlates of Traditional Eye Medicine (TEM use in a population of newly presenting ophthalmic outpatients attending a tertiary eye care centre in south-eastern Nigeria. Methods In a comparative cross-sectional survey at the eye clinic of the University of Nigeria Teaching Hospital (UNTH, Enugu, between August 2004 - July 2006, all newly presenting ophthalmic outpatients were recruited. Participants' socio-demographic and clinical data and profile of TEM use were obtained from history and examination of each participant and entered into a pretested questionnaire and proforma. Participants were subsequently categorized into TEM- users and non-users; intra-group analysis yielded proportions, frequencies, and percentages while chi-square test was used for inter-group comparisons at P = 0.01, df = 1. Results Of the 2,542 (males, 48.1%; females, 51.9% participants, 149 (5.9% (males, 45%; females, 55% used TEM for their current eye disease. The TEMs used were chemical substances (57.7%, plant products (37.7%, and animal products (4.7%. They were more often prescribed by non-traditional (66.4% than traditional (36.9% medicine practitioners. TEMs were used on account of vision loss (58.5%, ocular itching (25.4% and eye discharge (3.8%. Reported efficacy from previous users (67.1% and belief in potency (28.2% were the main reasons for using TEM. Civil servants (20.1%, farmers (17.7%, and traders (14.1% were the leading users of TEM. TEM use was significantly associated with younger age (p Conclusion The incidence of TEM use among new ophthalmic outpatients at UNTH is low. The reasons for TEM use are amenable to positive change through enhanced delivery of promotive, preventive, and curative public eye care services. This has implications for eye care planners and implementers. To reverse the trend, we suggest strengthening of eye care programmes, even

The eye of the Barbary sheep or aoudad (Ammotragus lervia: Reference values for selected ophthalmic diagnostic tests, morphologic and biometric observations

Directory of Open Access Journals (Sweden)

G.A. Fornazari

2016-06-01

Full Text Available The purpose of this study was to describe the normal ocular anatomy and establish reference values for ophthalmic tests in the Barbary sheep or aoudad (Ammotragus lervia. Aoudad eyes are large and laterally positioned in the head with several specialized anatomic features attributed to evolutionary adaptations for grazing. Normal values for commonly used ophthalmic tests were established, Schirmer tear test (STT - 27.22 ± 3.6 mm/min; Predominant ocular surface bacterial microbiota - Staphylococcus sp.; Corneal esthesiometry- 1.3 ± 0.4 cm; Intraocular pressure by rebound tonometry- 19.47 ± 3.9 mmHg; Corneal thickness- 630.07 ± 20.67 μm, B-mode ultrasonography of the globe- axial eye globe length 29.94 ± 0.96 mm, anterior chamber depth 5.03 ± 0.17 mm, lens thickness 9.4 ± 0.33 mm, vitreous chamber depth 14.1 ± 0.53 mm; Corneal diameter- horizontal corneal diameter 25.05 ± 2.18 mm, vertical corneal diameter 17.95 ± 1.68 mm; Horizontal palpebral fissure length- 34.8 ± 3.12 mm. Knowledge of these normal anatomic variations, biometric findings and normal parameters for ocular diagnostic tests may assist veterinary ophthalmologists in the diagnosis of ocular diseases in this and other similar species.

Pituitary dysfunction from an unruptured ophthalmic internal carotid artery aneurysm with improved 2-year follow-up results: A case report

Directory of Open Access Journals (Sweden)

Qi Meng

2018-04-01

Full Text Available Internal carotid artery (ICA supraclinoid segment aneurysms extending into the sellar region and leading to pituitary dysfunction are a rare occurrence. To date, long-term follow up of pituitary function 2 years post-treatment has never been reported. Herein, we present a case of pituitary dysfunction due to an unruptured ophthalmic segment internal carotid artery aneurysm and report improved 2-year follow-up results. A 76-year-old male presented with disturbed consciousness due to hyponatremia, which was caused by hypoadrenocorticism resulting from pituitary dysfunction complicated by hypogonadism and hypothyroidism. Computed tomography angiography revealed an intracranial aneurysm of the ophthalmic segment of the right ICA with an intrasellar extension. Thus, digital subtraction angiography and coil embolization were performed, followed by hormone replacement therapy. A 2-year follow-up revealed a partial improvement in the pituitary function, including complete restoration of thyroid-stimulating hormone level and other thyroid hormones levels, and partial restoration of testosterone levels, followed by discontinuation of thyroid hormone replacement therapy. However, the mechanisms of such pituitary dysfunction and the effects of various treatments, including clipping and coiling, on different hormones of pituitary function recovery remain unclear. A long-term follow-up of >2 years may elucidate the pituitary function recovery post-treatment and provide a medication adjustment for hormone replacement therapy.

Evaluation of MEWDS-like lesions with fluorescein angiography and its frequency at an ophthalmic emergency department in Rio de Janeiro

Directory of Open Access Journals (Sweden)

Lillian Abreu Dias

2015-08-01

Full Text Available ABSTRACTPurpose:To characterize multiple evanescent white dot syndrome (MEWDS-like lesions as diagnosed by clinical exam and fluorescein angiography (FA to build an epidemiological profile of this disease and highlight the most common angiographical aspects. It is important to emphasize the existence of this syndrome and improve patients’ information about the natural good course of this disease.Methods:A cross-sectional study including all FA performed from July 2006 to October 2012 (6,111 exams analyzed in patients at our ophthalmic emergency department, with analysis of the different angiographic aspects of the MEWDS-diagnosed cases.Results:Among the 6,111 angiographies analyzed, 15 MEWDS cases were detected; the patients ranged in age from 13 to 42 years old, and the male/female ratio was 60% to 40% (nine male and six female. The most common FA aspects included hyperfluorescent dots, dots and spots in the retinal mid-periphery, and foveal granularity in 46% of the cases.Conclusions:MEWDS has a good prognosis, with spontaneous involution, which makes it difficult to diagnose because of the delayed access to ophthalmological assistance, in special FA examination, which highlights the lesions. This study was possible due to the quick access facility at a private ophthalmic emergency department and examination by an experienced ophthalmologist, along with complementary diagnosis by FA and better perception of the patients, thus ensuring good prognosis.

Evaluation of MEWDS-like lesions with fluorescein angiography and its frequency at an ophthalmic emergency department in Rio de Janeiro.

Science.gov (United States)

Dias, Lillian Abreu; Morizot, Eduardo H

2015-01-01

To characterize multiple evanescent white dot syndrome (MEWDS)-like lesions as diagnosed by clinical exam and fluorescein angiography (FA) to build an epidemiological profile of this disease and highlight the most common angiographical aspects. It is important to emphasize the existence of this syndrome and improve patients' information about the natural good course of this disease. A cross-sectional study including all FA performed from July 2006 to October 2012 (6,111 exams analyzed) in patients at our ophthalmic emergency department, with analysis of the different angiographic aspects of the MEWDS-diagnosed cases. Among the 6,111 angiographies analyzed, 15 MEWDS cases were detected; the patients ranged in age from 13 to 42 years old, and the male/female ratio was 60% to 40% (nine male and six female). The most common FA aspects included hyperfluorescent dots, dots and spots in the retinal mid-periphery, and foveal granularity in 46% of the cases. MEWDS has a good prognosis, with spontaneous involution, which makes it difficult to diagnose because of the delayed access to ophthalmological assistance, in special FA examination, which highlights the lesions. This study was possible due to the quick access facility at a private ophthalmic emergency department and examination by an experienced ophthalmologist, along with complementary diagnosis by FA and better perception of the patients, thus ensuring good prognosis.

Infraorbital nerve involvement on magnetic resonance imaging in European patients with IgG4-related ophthalmic disease: a specific sign.

Science.gov (United States)

Soussan, J Ben; Deschamps, R; Sadik, J C; Savatovsky, J; Deschamps, L; Puttermann, M; Zmuda, M; Heran, F; Galatoire, O; Picard, H; Lecler, A

2017-04-01

To measure the frequency of infraorbital nerve enlargement (IONE) on magnetic resonance imaging (MRI) in European patients suffering from an IgG4-related ophthalmic disease (IgG4-ROD) as compared to patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD). From January 2006 through April 2015, 132 patients were admitted for non-lymphoma, non-thyroid-related orbital inflammation. Thirty-eight had both pre-therapeutic orbital MRI and histopathological IgG4 immunostaining. Fifteen patients were classified as cases of IgG4-ROD and 23 patients as cases of non-IgG4-ROD. Two readers performed blinded analyses of MRI images. The main criterion was the presence of an IONE, defined as the infraorbital nerve diameter being greater than the optic nerve diameter in the coronal section. IONE was present in 53% (8/15) of IgG4-ROD cases whereas it was never present (0/23) in cases of non-IgG4-ROD (P IgG4-ROD. Recognition of this pattern may facilitate the accurate diagnosis for clinicians and allow for the adequate management and appropriate care of their patients. • IONE on an MRI is a specific sign of IgG4-ROD. • IONE recognition allows for a quicker diagnosis and appropriate management. • IONE appears when inflammation is in direct contact with the ION canal.

Colour Doppler analysis of ophthalmic vessels in the diagnosis of carotic artery and retinal vein occlusion, diabetic retinopathy and glaucoma: systematic review of test accuracy studies.

Science.gov (United States)

Bittner, Mario; Faes, Livia; Boehni, Sophie C; Bachmann, Lucas M; Schlingemann, Reinier O; Schmid, Martin K

2016-12-07

Colour Doppler analysis of ophthalmic vessels has been proposed as a promising tool in the diagnosis of various eye diseases, but the available diagnostic evidence has not yet been assessed systematically. We performed a comprehensive systematic review of the literature on the diagnostic properties of Colour Doppler imaging (CDI) assessing ophthalmic vessels and provide an inventory of the available evidence. Eligible papers were searched electronically in (Pre) Medline, Embase and Scopus, and via cross-checking of reference lists. The minimum requirement to be included was the availability of original data and the possibility to construct a two-by-two table. Study selection, critical appraisal using the QUADAS II instrument and extraction of salient study characteristics was made in duplicate. Sensitivity and specificity was computed for each study. We included 11 studies (15 two-by-two tables) of moderate methodological quality enrolling 820 participants (range 30 to 118). In 44.4% participants were female (range 37-59% in specific subgroups). CDI was assessed for internal carotid stenosis, diabetic retinopathy, glaucoma, and branch or central retinal vein occlusion diagnosis. There was insufficient data to pool the results for specific illnesses. For the assessments of ophthalmic arteries, mean sensitivity was 0.69 (range 0.27-0.96) with a corresponding mean specificity of 0.83 (range 0.70-0.96). Mean sensitivity of the central retinal artery assessments was 0.58 (range 0.31-0.84) and the corresponding mean specificity was 0.82 (range 0.63-0.94). Robust assessments of the diagnostic value of colour Doppler analysis remain uncommon, limiting the possibilities to extrapolate its true potential for clinical practice. PROSPERO 2014:CRD42014014027.

Development of a reference system and a methodology for the calibration of ophthalmic applicators utilized in brachytherapy

International Nuclear Information System (INIS)

Oliveira, Mercia Liane de

2005-01-01

90 Sr+ 90 Y beta radiation sources are widely utilized in brachytherapy, in the treatment of superficial lesions of eyes and skin. According to international recommendations, these applicators should be specified in terms of the absorbed dose rate to water at the reference point (1 mm from the source surface, along its axis of symmetry). Two mini-extrapolation chambers were developed with adequate geometrical characteristics for the dosimetry of plane and concave 90 Sr+ 90 Y sources. These chambers have 3.0 cm of outer diameter and 11.3 cm of length. Aluminized polyester foils are used as entrance windows, and the collecting electrodes were made of graphited polymethylmethacrylate. The mini-chambers were tested in 90 Sr+ 90 Y radiation beams from a beta check source and plane and concave ophthalmic applicators. All results obtained show the usefulness of these chambers as reference primary standards for the calibration of 90 Sr+ 90 Y applicators. The previous calibration of the mini-chambers in relation to a standard ionization chamber or to a standard beta source is unnecessary. The minichamber with plane window showed utility for low energy X-rays too. In order to establish an alternative method for the calibration of beta radiation sources, different thermoluminescent materials were tested: LiF, CaF 2 :Mn, CaF 2 :Dy and CaS0 4 :Dy. For their characterization, the response reproducibility, calibration curves, TL response as a function of the source-detector distance, transmission factors and the linearity of the sample response were determined. The calibration procedures of ophthalmic applicators were established utilizing the ionometric technique and thermoluminescence dosimetry. (author)

Dosimetric Benefit of a New Ophthalmic Radiation Plaque

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Marwaha, Gaurav, E-mail: marwahg2@ccf.org [Department of Radiation Oncology, Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Cleveland Clinic Foundation, Cleveland, Ohio (United States); Wilkinson, Allan [Department of Radiation Oncology, Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Cleveland Clinic Foundation, Cleveland, Ohio (United States); Bena, James [Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Cleveland Clinic Foundation, Cleveland, Ohio (United States); Macklis, Roger [Department of Radiation Oncology, Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Cleveland Clinic Foundation, Cleveland, Ohio (United States); Singh, Arun D. [Department of Radiation Oncology, Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Department of Ophthalmic Oncology, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio (United States); Cleveland Clinic Foundation, Cleveland, Ohio (United States)

2012-12-01

Purpose: To determine whether the computed dosimetry of a new ophthalmic plaque, EP917, when compared with the standard Collaborative Ocular Melanoma Study (COMS) plaques, could reduce radiation exposure to vision critical structures of the eye. Methods and Materials: One hundred consecutive patients with uveal melanoma treated with COMS radiation plaques between 2007 and 2010 were included in this study. These treatment plans were generated with the use of Bebig Plaque Simulator treatment-planning software, both for COMS plaques and for EP917 plaques using I-125. Dose distributions were calculated for a prescription of 85 Gy to the tumor apex. Doses to the optic disc, opposite retina, lens, and macula were obtained, and differences between the 2 groups were analyzed by standard parametric methods. Results: When compared with the COMS plaques, the EP917 plaques used fewer radiation seeds by an average difference of 1.94 (P<.001; 95% confidence interval [CI], -2.8 to -1.06) and required less total strength of radiation sources by an average of 17.74 U (air kerma units) (P<.001; 95% CI, -20.16 to -15.32). The total radiation doses delivered to the optic disc, opposite retina, and macula were significantly less by 4.57 Gy, 0.50 Gy, and 11.18 Gy, respectively, with the EP917 plaques vs the COMS plaques. Conclusion: EP917 plaques deliver less overall radiation exposure to critical vision structures than COMS treatment plaques while still delivering the same total therapeutic dose to the tumor.

Dosimetric Benefit of a New Ophthalmic Radiation Plaque

International Nuclear Information System (INIS)

Marwaha, Gaurav; Wilkinson, Allan; Bena, James; Macklis, Roger; Singh, Arun D.

2012-01-01

Purpose: To determine whether the computed dosimetry of a new ophthalmic plaque, EP917, when compared with the standard Collaborative Ocular Melanoma Study (COMS) plaques, could reduce radiation exposure to vision critical structures of the eye. Methods and Materials: One hundred consecutive patients with uveal melanoma treated with COMS radiation plaques between 2007 and 2010 were included in this study. These treatment plans were generated with the use of Bebig Plaque Simulator treatment-planning software, both for COMS plaques and for EP917 plaques using I-125. Dose distributions were calculated for a prescription of 85 Gy to the tumor apex. Doses to the optic disc, opposite retina, lens, and macula were obtained, and differences between the 2 groups were analyzed by standard parametric methods. Results: When compared with the COMS plaques, the EP917 plaques used fewer radiation seeds by an average difference of 1.94 (P<.001; 95% confidence interval [CI], −2.8 to −1.06) and required less total strength of radiation sources by an average of 17.74 U (air kerma units) (P<.001; 95% CI, −20.16 to −15.32). The total radiation doses delivered to the optic disc, opposite retina, and macula were significantly less by 4.57 Gy, 0.50 Gy, and 11.18 Gy, respectively, with the EP917 plaques vs the COMS plaques. Conclusion: EP917 plaques deliver less overall radiation exposure to critical vision structures than COMS treatment plaques while still delivering the same total therapeutic dose to the tumor.

Reversal in the Diameter of the Superior Ophthalmic Vein after an Epidural Blood Patch in a Case of Spontaneous Intracranial Hypotension

International Nuclear Information System (INIS)

Hsiao, Chen Yu; Tsai, Yuh Feng

2011-01-01

Spontaneous intracranial hypotension (SIH) is caused by single or multiple cerebrospinal fluid (CSF) leaks in the spine with the prototypical symptom of postural headache. One of the characteristic MRI features in SIH is intracranial venous engorgement. This report presents a case of SIH with engorgement of the bilateral superior ophthalmic veins (SOVs) which resume their normal diameters by the third day of successful epidural blood patches (EBPs). We define this phenomenon as the 'reversal of the SOV' sign.

Moorfields technique of donor cornea mounting for femtosecond-assisted keratoplasty: use of viscoelastic in the artificial anterior chamber.

Science.gov (United States)

Iovieno, Alfonso; Chowdhury, Vivek; Stevens, Julian D; Maurino, Vincenzo

2012-07-01

Appropriate mounting and cutting of the donor sclero-corneal cap is often cumbersome during femtosecond laser-assisted keratoplasty. The authors describe a technique for donor cornea femtosecond laser cutting using ophthalmic viscoelastic devices. The donor sclero-corneal cap is mounted on the artificial anterior chamber using a dispersive ophthalmic viscoelastic device instead of saline solution. The chances of artificial anterior chamber pressure loss, inadequate applanation, and fluid leaks are consistently reduced with the use of dispersive ophthalmic viscoelastic devices. The speed of donor femtosecond laser cutting is increased. The viscosity and elasticity of dispersive ophthalmic viscoelastic devices greatly assist the procedure with regard to ease of applanation, corneal endothelium protection, and decreased distortion of the applanated cornea. Copyright 2012, SLACK Incorporated.

Acanthamoeba encystment: multifactorial effects of buffers, biocides, and demulcents present in contact lens care solutions

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Kovacs CJ

2015-10-01

Full Text Available Christopher J Kovacs, Shawn C Lynch, Marjorie J Rah, Kimberly A Millard, Timothy W Morris Bausch & Lomb Incorporated, Rochester, NY, USA Purpose: To determine whether agents which are purportedly capable of inducing encystment of Acanthamoeba can recapitulate the signal when tested in differing formulations. Methods: In accordance with the International Standard ISO 19045, Acanthamoeba castellanii ATCC 50370 trophozoites were cultured in antibiotic-free axenic medium, treated with test solutions, and encystment rates plus viability were measured via bright field and fluorescent microscopy. Test solutions included phosphate-buffered saline (PBS, borate-buffered saline, biguanide- and hydrogen peroxide (H2O2-based biocides, propylene glycol (PG and povidone (POV ophthalmic demulcents, and one-step H2O2-based contact lens disinfection systems. Results: Only PBS solutions with 0.25 ppm polyaminopropyl biguanide (PAPB and increasing concentrations of PG and POV stimulated A. castellanii encystment in a dose-dependent manner, whereas PBS solutions containing 3% H2O2 and increasing concentrations of PG and POV did not stimulate encystment. Borate-buffered saline and PBS/citrate solutions containing PG also did not stimulate encystment. In addition, no encystment was observed after 24 hours, 7 days, or 14 days of exposures of trophozoites to one-step H2O2 contact lens disinfection products or related solutions. Conclusion: The lack of any encystment observed when trophozoites were treated with existing or new one-step H2O2 contact lens care products, as well as when trophozoites were exposed to various related test solutions, confirms that Acanthamoeba encystment is a complex process which depends upon simultaneous contributions of multiple factors including buffers, biocides, and demulcents. Keywords: propylene glycol, contact lens care system, hydrogen peroxide disinfecting solution

Toward the development of a low-cost laser Doppler module for ophthalmic microscopes

Science.gov (United States)

Cattini, Stefano; Rovati, Luigi

2012-03-01

A laser Doppler module easily integrated into a commercial ophthalmic microscope is proposed. Such setup adds flow measurement capability to standard visual inspection of the fundus. The proposed instrument may provide important clinical information such as the detection of vessel occlusion provided by surgical treatments (i.e. photocoagulation). The measuring system is based on a self-mixing laser diode Doppler flowmeter (SM-DF). Reduced costs, easy implementation and small size represent the main features of SM-DF. Moreover, this technique offers the advantage to have the excitation and measurement beams spatially overlapped, thus both overcoming the alignment difficulty of traditional laser Doppler flowmeter and, well fitting with to limited optical aperture of the pupil. Thanks to an on-board DSP-microcontroller, the optoelectronic module directly estimates the blood flow; USB connection and an ad-hoc developed user-friendly software interface allow displaying the result on a personal computer. Preliminary test demonstrates the applicability of the proposed measuring system.

Evaluation the index of ophthalmic arteries in diabetic patients with retinopathy compared to diabetic patients without retinopathy using color Doppler ultrasound

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Mohammad Ghasem Hanafi

2016-12-01

Full Text Available Diabetic retinopathy is the most common eye complication in diabetic patients that early detection of this complication is essential. The aim of this study was to evaluate ophthalmic artery index in diabetic retinopathy by Doppler ultrasound. . In this cross-sectional study, 64 patients were studied in 4 groups (healthy, diabetic without retinopathy, background retinopathy and proliferative retinopathy. Resistance index (RI and Pulsatile Index (PI were assessed by color Doppler ultrasound. The obtained data were analyzed by ANOVA and chi-square test and ROC curve. RI in diabetic patients with proliferative retinopathy has the highest mean (0.83 and the lowest mean was observed in healthy subjects (0.54 (P <0.001 as well as in PI, the highest rate was in diabetic patients with proliferative retinopathy (1.41 and the lowest was in healthy subjects (0.92 (P <0.001. The results of our study showed that the sensitivity, specificity, positive and negative predictive values and overall accuracy of RI and PI in diabetic patients with proliferative retinopathy in the best cut-off points (0.645 and 1.0175 respectively were 100%.Ophthalmic artery index RI and PI was significantly increased in patients with diabetic retinopathy and the sensitivity and specificity for detection retinopathy was 100%. Color Doppler ultrasound method is more efficient for screening diabetic patients with retinopathy.

A method for the calibration of concave sup 90 Sr+ sup 90 Y ophthalmic applicators

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Soares, C G [National Inst. of Standards and Technology, Gaithersberg, MD (United States). Ionizing Radiation Div.

1992-04-01

At the Amersham Laboratory (Amersham, UK) absorbed-dose rate in tissue at a depth of 7 mg cm{sup -2} from curved ophthalmic applicators is measured with calibrated scintillator probes (Amersham International 1979, Sinclair and Trott 1956). The probes are approximately 3 mm in diameter, 0.5 mm thick and are covered with 7 mg cm{sup -2} of aluminium. They are calibrated using standard sources whose dose rate has been determined using an extrapolation chamber equipped with a 3 mm diameter collecting electrode. Crucial to this technique is the availability of well calibrated sources of nearly the same geometry and dose rate as the source to be calibrated. A technique is presented here which yields accurate measurement of the surface absorbed-dose rate in a very simple and straightforward fashion. (author).

Design and Evaluation of Voriconazole Eye Drops for the Treatment of Fungal Keratitis

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Sakshi Malhotra

2014-01-01

Full Text Available Voriconazole is a novel antifungal agent with excellent broad spectrum activity commercially available for oral and intravenous administration. The purpose of this study was to prepare ophthalmic formulation of hydroxypropyl beta cyclodextrin (HP-β-CD based voriconazole containing benzalkonium chloride BAK and EDTA with or without viscosity modifiers and study its permeation characteristics through freshly excised goat cornea. The results were observed that viscosity and force of bioadhesion of the voriconazole HP-β-CD solutions containing xanthan gum (XG are more as compared to polyvinyl alcohol. The results revealed that voriconazole drop containing PVA provided least viscosity and higher corneal permeation of drug, while drop formulated with XG had maximum viscosity and least permeation. The HP-β-CD based voriconazole (1.5% ophthalmic formulation containing xanthan gum (1.5, preserved with BAK and EDTA, could provide shelf life of 2 years. The microbiological studies showed that voriconazole ophthalmic solution containing xanthan gum shows better antifungal activity as compared to voriconazole and xanthan gum alone. Thus, it can be concluded that HP-β-CD based voriconazole (1.5%, pH 7.0 ophthalmic solution containing BAK and EDTA with viscosity modifier XG provided maximum precorneal residence time as compared to other viscosity modifiers and polyvinyl alcohol provided less precorneal residence time than other viscosity modifiers.

Endovascular treatment of a cavernous sinus dural arteriovenous fistula by transvenous embolisation through the superior ophthalmic vein via cannulation of a frontal vein

International Nuclear Information System (INIS)

Venturi, C.; Bracco, S.; Cerase, A.; Gennari, P.; Lore, F.; Polito, E.; Casasco, A.E.

2003-01-01

We describe a new approach for transvenous embolisation of cavernous sinus dural arteriovenous fistulae through the superior ophthalmic vein (SOV), i.e., via percutaneous cannulation of a frontal vein. Modern neurointerventional angiographic materials make it possible to reach the SOV in this way without puncturing it in the orbit or a surgical exposure. Orbital phlebography should still be in the repertoire of interventional neuroradiology units in large centres. (orig.)

Infraorbital nerve involvement on magnetic resonance imaging in European patients with IgG4-related ophthalmic disease: a specific sign

Energy Technology Data Exchange (ETDEWEB)

Soussan, J. Ben; Sadik, J.C.; Savatovsky, J.; Heran, F.; Lecler, A. [Fondation Ophtalmologique Adolphe de Rothschild, Department of Radiology, Paris (France); Deschamps, R. [Fondation Ophtalmologique Adolphe de Rothschild, Department of Neurology, Paris (France); Deschamps, L. [Bichat Hospital, APHP, Department of Pathology, Paris (France); Puttermann, M. [Necker-Enfants Malades Hospital, APHP, Department of Pathology, Paris (France); Zmuda, M.; Galatoire, O. [Fondation Ophtalmologique Adolphe de Rothschild, Department of Orbitopalpebral Surgery, Paris (France); Picard, H. [Fondation Ophtalmologique Adolphe de Rothschild, Clinical Research Unit, Paris (France)

2017-04-15

To measure the frequency of infraorbital nerve enlargement (IONE) on magnetic resonance imaging (MRI) in European patients suffering from an IgG4-related ophthalmic disease (IgG4-ROD) as compared to patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD). From January 2006 through April 2015, 132 patients were admitted for non-lymphoma, non-thyroid-related orbital inflammation. Thirty-eight had both pre-therapeutic orbital MRI and histopathological IgG4 immunostaining. Fifteen patients were classified as cases of IgG4-ROD and 23 patients as cases of non-IgG4-ROD. Two readers performed blinded analyses of MRI images. The main criterion was the presence of an IONE, defined as the infraorbital nerve diameter being greater than the optic nerve diameter in the coronal section. IONE was present in 53% (8/15) of IgG4-ROD cases whereas it was never present (0/23) in cases of non-IgG4-ROD (P < 0.0001). IONE was only present in cases where, on MRI, the inflammation of the inferior quadrant was present and in direct contact with the ION canal. In European patients suffering from orbital inflammation, the presence of IONE on an MRI is a specific sign of IgG4-ROD. Recognition of this pattern may facilitate the accurate diagnosis for clinicians and allow for the adequate management and appropriate care of their patients. (orig.)

Infraorbital nerve involvement on magnetic resonance imaging in European patients with IgG4-related ophthalmic disease: a specific sign

International Nuclear Information System (INIS)

Soussan, J. Ben; Sadik, J.C.; Savatovsky, J.; Heran, F.; Lecler, A.; Deschamps, R.; Deschamps, L.; Puttermann, M.; Zmuda, M.; Galatoire, O.; Picard, H.

2017-01-01

To measure the frequency of infraorbital nerve enlargement (IONE) on magnetic resonance imaging (MRI) in European patients suffering from an IgG4-related ophthalmic disease (IgG4-ROD) as compared to patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD). From January 2006 through April 2015, 132 patients were admitted for non-lymphoma, non-thyroid-related orbital inflammation. Thirty-eight had both pre-therapeutic orbital MRI and histopathological IgG4 immunostaining. Fifteen patients were classified as cases of IgG4-ROD and 23 patients as cases of non-IgG4-ROD. Two readers performed blinded analyses of MRI images. The main criterion was the presence of an IONE, defined as the infraorbital nerve diameter being greater than the optic nerve diameter in the coronal section. IONE was present in 53% (8/15) of IgG4-ROD cases whereas it was never present (0/23) in cases of non-IgG4-ROD (P < 0.0001). IONE was only present in cases where, on MRI, the inflammation of the inferior quadrant was present and in direct contact with the ION canal. In European patients suffering from orbital inflammation, the presence of IONE on an MRI is a specific sign of IgG4-ROD. Recognition of this pattern may facilitate the accurate diagnosis for clinicians and allow for the adequate management and appropriate care of their patients. (orig.)

Multiscale modelling approach combining a kinetic model of glutathione metabolism with PBPK models of paracetamol and the potential glutathione-depletion biomarkes ophthalmic acid and 5-oxoproline in humans and rats

NARCIS (Netherlands)

Geenen, S.; Yates, J.W.T.; Kenna, J.G.; Bois, F.Y.; Wilson, I.D.; Westerhoff, H.V.

2014-01-01

A key role of the antioxidant glutathione is detoxification of chemically reactive electrophilic drug metabolites within the liver. Therefore glutathione depletion can have severe toxic consequences. Ophthalmic acid and 5-oxoproline are metabolites involved in glutathione metabolism, which can be

Design and construction of ophthalmic simulators for clinical applications

International Nuclear Information System (INIS)

Sanchez, Andrea

2006-01-01

This work presents a calculational methodology for dose determination in human eye structures, such as: sclera, choroid, retina, lens, vitreous body, optic nerve and disc, and cornea, as well as tumor due to treatment to the eye plaques. A human eye model was constructed taking into consideration its main structural and dimension characteristics. Beyond that a mathematical model for the Co-60 and 1-125 plaques with all geometric details were built employing the MCNP-4C code. This model is able to calculate the axial and radial doses in any point of the eye and for each of its structures. An acrylic eye simulator was also built with the aim to obtain experimental results for the both model validations. This simulator is made of an acrylic sphere split into foils of 1 mm thickness which allow the introduction of a radiographic film to measure the axial and radial doses. The experimental data were used to validate the MCNP-4C results. The data from the mathematical model will serve as the basis to build a data bank for all the eye structures allowing different position and sizes of tumor as well as the replacement of all ophthalmic plaques used in the treatment. This data bank will be the principal part for the construction of a national software for the dose calculation and can be of great help for a reliable treatment system planning in radiotherapy/brachytherapy. (author)

The Influence of Early Ophthalmic Hospitals on the Journal.

Science.gov (United States)

Pathipati, Akhilesh S; Tsai, James C

2018-05-09

To consider the American Journal of Ophthalmology's (AJO's) role not only as a forum to describe clinical and scientific advances but also as a record of institutional histories. We used the New York Eye and Ear Infirmary of Mount Sinai, the Massachusetts Eye and Ear Infirmary, and the Wills Eye Hospital as case studies on the Journal's role in documenting the people and organizations that have moved ophthalmology forward. Perspective. Using the ScienceDirect database, we conducted a literature search to gather all mentions of the 3 eye hospitals in the Journal's archives from 1918 to 2018. We evaluated those search results to identify a few of the individuals and articles that highlight how the history of eye institutions are reflected in the AJO. Searches for the aforementioned 3 hospitals yielded over 3400 results in Journal archives. These included articles on their histories, proceedings from clinical case conferences, profiles of prominent surgeons, and information about educational offerings, among others. Many of those articles were written by physicians from those institutions who also served on the AJO's editorial board or had a long history of publishing in the Journal. The AJO has played a crucial role in the last 100 years as a register of ophthalmic history. The New York Eye and Ear Infirmary of Mount Sinai, Massachusetts Eye and Ear Infirmary, and Wills Eye Hospital provide 3 examples of how that role manifests. Copyright © 2018 Elsevier Inc. All rights reserved.

Transvenous embolization of indirect carotid-cavernous fistula via upper ophthalmic/facial vein - Case report and literature review

International Nuclear Information System (INIS)

Sirakov, S.; Penkov, M.; Sirakov, A.; Kamenov, B.; Todorov, Y.; Ninov, K.; Bachvarov, Ch.

2015-01-01

Indirect carotid-cavernous fistula or dural arterio-venous fistula of cavernous sinus is relatively rare pathologic finding. Different classifications of carotid-cavernous fistulae are proposed. Now days more and more they are treated by endovascular approach. A case of authors' practice of transvenous embolization of carotid-cavernous fistula via upper ophthalmic vein in 52 year old female is presented with review of the literature. A week later ocular symptoms of the patient regressed. Control angiography at the third month follow up does not visualize fistula. The transvenous approach in management of carotid cavernous fistulae is safe and effective in cases direct arterial approach is absent or technically impossible. Key words: Indirect Carotid-Cavernous Fistula. Embolization. Transvenous Approach

Ophthalmic nepafenac use in the Netherlands and Denmark.

Science.gov (United States)

Margulis, Andrea V; Houben, Eline; Hallas, Jesper; Overbeek, Jetty A; Pottegård, Anton; Torp-Pedersen, Tobias; Perez-Gutthann, Susana; Arana, Alejandro

2017-08-01

To describe nepafenac use in the Netherlands and Denmark with reference to its approved indications. For context, we also describe the use of ketorolac and diclofenac. We identified users in the PHARMO Database Network (the Netherlands, 2008-2013) and the Danish national health registers (Denmark, 1994-2014). We described prevalence of cataract surgery and duration of use in patients with cataract surgery with and without diabetes. In the Netherlands, 9530 nepafenac users (mean age, 71 years; 60% women) contributed 12 691 therapy episodes, of which 21% had a recently recorded cataract surgery. Of 2266 episodes in adult non-diabetic patients with cataract surgery, 60% had one bottle dispensed (treatment duration ≤21 days). Of 441 episodes in adult diabetic patients with cataract surgery, 90% had up to two bottles dispensed (≤60 days). Denmark had 60 403 nepafenac users (mean age, 72 years; 58% women) and 73 648 episodes (41% had recorded cataract surgery). Of 26 649 nepafenac episodes in adult non-diabetic patients with cataract surgery, 92% had one bottle dispensed. Of 3801 episodes in adult diabetic patients with cataract surgery, 99.8% had up to two bottles dispensed. Use patterns of nepafenac, ketorolac and diclofenac were roughly similar in the Netherlands, but not in Denmark. Less than half of therapy episodes were related to cataract surgery; around 90% of episodes with surgery were within the approved duration. Underrecording of ophthalmic conditions and procedures was a challenge in this study. © 2017 The Authors Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

Self-assembled liquid crystalline nanoparticles as a novel ophthalmic delivery system for dexamethasone: Improving preocular retention and ocular bioavailability.

Science.gov (United States)

Gan, Li; Han, Shun; Shen, Jinqiu; Zhu, Jiabi; Zhu, Chunliu; Zhang, Xinxin; Gan, Yong

2010-08-30

The object of this study was to design novel self-assembled liquid crystalline nanoparticles (cubosomes) as an ophthalmic delivery system for dexamethasone (DEX) to improve its preocular retention and ocular bioavailability. DEX cubosome particles were produced by fragmenting a cubic crystalline phase of monoolein and water in the presence of stabilizer Poloxamer 407. Small angle X-ray diffraction (SAXR) profiles revealed its internal structure as Pn3m space group, indicating the diamond cubic phase. In vitro, the apparent permeability coefficient of DEX administered in cubosomes exhibited a 4.5-fold (F1) and 3.5-fold (F2) increase compared to that of Dex-Na phosphate eye drops. Preocular retention studies revealed that the retention of cubosomes was significantly longer than that of solution and carbopol gel, with AUC(0-->180min) of Rh B cubosomes being 2-3-fold higher than that of the other two formulations. In vivo pharmacokinetics in aqueous humor was evaluated by microdialysis, which indicated a 1.8-fold (F1) increase in AUC(0-->240min) of DEX administered in cubosomes relative to that of Dex-Na phosphate eye drops, with about an 8-fold increase compared to that of DEX suspension. Corneal cross-sections after incubation with DEX cubosomes demonstrated an unaffected corneal structure and tissue integrity, which indicated the good biocompatibility of DEX cubosomes. In conclusion, self-assembled liquid crystalline nanoparticles might represent a promising vehicle for effective ocular drug delivery. Crown Copyright 2010. Published by Elsevier B.V. All rights reserved.

Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease.

Science.gov (United States)

Huang, Jing-Feng; Yafawi, Rolla; Zhang, Min; McDowell, Michael; Rittenhouse, Kay D; Sace, Frederick; Liew, Shiao Hui Melissa; Cooper, Scott R; Pickering, Eve H

2012-07-01

To evaluate the immunomodulatory effect of topical ophthalmic tofacitinib (CP-690,550) after an 8-week treatment period in patients with dry eye disease (DED). Biomarker substudy of a phase 1/2 prospective, randomized, vehicle- and comparator-controlled clinical trial (NCT00784719). A total of 82 patients with moderate to severe DED enrolled. Patients received 1 of 5 doses of tofacitinib (0.0003%, 0.001%, 0.003%, or 0.005% twice daily [BID] or 0.005% once daily [QD]), active comparator (cyclosporine ophthalmic emulsion, 0.05% [Restasis, Allergan Inc., Irvine, CA]), or vehicle control BID for 8 weeks. Conjunctival impression cytology and tear fluid samples were collected at baseline and after an 8-week treatment period. Conjunctival cells were analyzed by flow cytometry for human leukocyte antigen DR-1 (HLA-DR). Tear fluids were analyzed by microsphere-based immunoassays for tear levels of cytokines and inflammation markers. Reduction in inflammation assessed by change from baseline in conjunctival cell surface level of HLA-DR and tear level of cytokines and inflammation markers. At week 8, a decrease in conjunctival cell surface expression of HLA-DR was observed in patients treated with tofacitinib 0.005% QD and 0.003% BID: 71% and 67% of baseline, respectively, compared with 133% of baseline in patients treated with vehicle (P=0.023 and P=0.006, compared with vehicle, respectively). Matrix metalloproteinase (MMP)-3 in tears was reduced from baseline at week 8 (40% of baseline, P=0.035) in the tofacitinib 0.005% QD group, whereas the vehicle group showed 77% of baseline (P>0.20). Interleukin (IL)-1β in tears was 36% of baseline (P=0.053) in the tofacitinib 0.005% QD group and 95% of baseline (P > 0.20) in the vehicle group. Several other cytokines and inflammation markers in tears, including MMP-9, IL-15, IL-17A, and IL-12p70, were markedly reduced in the tofacitinib 0.005% QD group but not the vehicle group. There was an association between the changes in HLA

Malassezia pachydermatis keratomycosis in a dog

Directory of Open Access Journals (Sweden)