Comparison of Preservative-free Non-Steroidal Anti-Inflammatory Drug and Preservative-free Corticosteroid after Uncomplicated Cataract Surgery : A multicenter, Randomized, Evaluator-blinded, Between-two-eye Clinical trial

The Catholic University of Korea, Yeouido St. Mary's Hospital0 个研究点目标入组 123 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

暂无简介。

•1. bilateral senile cataract (=50 years old) with nuclear opalescence/color 3~4 and no posterior subcapsular cataract according to the Lens Opacities Classification System III scale
•2. scheduled to get cataract surgeries for both eyes with less than 7day interval between the two
•3. corneal endothelial density =1,500 cells/? for both eyes
•4. volentary agreement with signed informed consent

•1. current or history of ocular disorders possibly affecting the study results(ocular surgery, malformation or diseases)
•1) eye trauma, corneal transplantation
•2) congenital cataract, aniridia, iris atrophy
•3) visual acquity affecting retinal disease like diabetic retinopathy, epiretinal membrane, retinal edema etc
•4) pseudoexfoliation syndrome
•5) other inappropriate conditions by ophthalmologist's judge
•2. medical condition to be treated with topical agents besides artifical tear within 2 weeks from cataract surgery and during the study period
•1) chronic or recurrent ocular inflammatory diseases lik uveitis, scleritis etc
•2) glaucoma, ocular allergy, dry eye to be treated with drops
•3. systemic diseases affecting the study results
•1) uncontrolled diabetes or hypertension
•2) conditions to take systemic steroid or NSAID(non-steroidal anti-inflammatory drug) within 2 weeks(45 days for delayed releasing formulation) from cataract surgery and during the study period
•4. investigator's judge to be treated with intensive anti-inflammatory therapy after surgery (surgery complication like posterior capsular rupture, vitreous loss etc)
•5. known hypersensitivity to study medications
•6. clinical study participants within 6 months
•7. pregnancy or lactation
•8. investigator's judge of inappropiation

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