Prospective, Randomized Study Comparing the Effect of 0.1% Nepafenac and 0.4% Ketorolac Tromethamine on Macular Thickness in Cataract Surgery Patients With Low Risk for Cystoid Macular Edema.

Abstract

This study aimed to compare the short-term efficacy of 0.1% nepafenac with that of 0.4% ketorolac tromethamine in patients with low risk factors for cystoid macular edema (CME) undergoing phacoemulsification. A prospective, randomized, parallel-assignment efficacy trial. Two hundred eyes of 200 patients were randomized into 2 groups, one receiving nepafenac and the other receiving ketorolac perioperatively. Primary outcome measures were change in central macular thickness (CMT) at the 30th postoperative day and the incidence of possible subclinical CME (increase in CMT of >10 and >40 μm from baseline) on ocular coherence tomography (OCT). Secondary outcomes measured were the incidence of definite subclinical CME on OCT (>40 μm increase in CMT from baseline) and clinically significant CME at 1-month follow-up. A subgroup analysis of diabetic and hypertensive patients included in the study was made postoperatively. Difference in CMT at 1 month (P = 0.43) and presence of possible subclinical CME (P = 0.18) were comparable in both groups. The incidence of possible subclinical CME was 22.7%. None of the patients developed clinical CME or definite subclinical CME. In the diabetic subgroup, nepafenac showed significantly less CMT difference than ketorolac did at 1 week after the operation (P = 0.04) but not at 1 month (P = 0.09). Postoperative macular thickening after cataract surgery in eyes with low CME risk is similar with nepafenac and ketorolac. A larger population of diabetic patients should be studied to verify any beneficial effect of nepafenac on this subgroup.