drugset / Trial / NCT03292796

RCT to Investigate if Prostaglandin Analogue Drops Increase the Risk of Cystoid Macular Oedema After Cataract Surgery.

NCT03292796

Phase 2 Completed 56 enrolled Julie Dawson
RandomizedParallel-groupSingle-blindTreatment

Summary

Post-operative cystoid macular oedema (CMO) is a common complication causing visual loss following routine cataract surgery. This complication is more prevalent in eyes with excessive inflammation as they heal from surgery. Prostaglandin analogues (PGA) are the commonest first line drugs used in the long-term treatment of primary open angle glaucoma (POAG)- where they reduce the pathologically high pressure in the eye. Prostaglandins are inflammatory mediators. In the post-operative care of glaucoma patients undergoing cataract surgery, there is a clinical dilemma whether to stop or continue the use of prostaglandin eye drops. Clinical practice is completely dichotomized between continuing and stopping PGA treatment in the postoperative period. There is conflicting scientific literature on the effect of PGA on the incidence of CMO; and only a single randomized control trial (Miyake K, Arch Ophthalmol 1999, 117:34-40), where the post operative regime is not applicable to present practice, compared the incidence of CMO following routine cataract surgery in POAG on PGA.

Timeline

Start
2016-12-07
Primary completion
2019-10-21
Completion
2020-07-25

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bimatoprost Other / unclassified Topical
Subject Latanoprost Small molecule Topical
Subject Tafluprost Other / unclassified Topical
Subject Travaprost Unknown Topical

Indications