drugset / Trial / NCT03383328

Study for Optimizing Anti-inflammatory Prophylaxis

NCT03383328

Phase 4 Completed 470 enrolled Line Kessel
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.

Timeline

Start
2018-02-01
Primary completion
2019-12-18
Completion
2019-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 2 mg Other
Comparator Ketorolac Tromethamine Small molecule 5 mg/ml Topical
Comparator Prednisolone Other / unclassified 1 % Topical

Indications