drugset / Trial / NCT07696104

Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification

NCT07696104

Phase 4 Completed 88 enrolled Pomeranian Medical University Szczecin
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.

Timeline

Start
2020-10-14
Primary completion
2024-05-22
Completion
2024-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Bromfenac Other / unclassified 0.09 % Topical
Subject Diclofenac Other / unclassified 0.1 % Topical
Subject Nepafenac Other / unclassified 0.1 % Topical

Indications