Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification

PURPOSE: To evaluate the efficacy of prophylactic ketorolac 0.5% versus nepafenac 0.1% versus placebo on rnacular volume 1 month after uneventful phacoemulsification and evaluate the health-related quality-of-life (HRQOL) of topical nonsteroidal antiinflammatory drugs (NSAIDs) in the context of cataract surgery. SETTING: Hotel Dieu Hospital, Kingston, Ontario, Canada. DESIGN: Prospective placebo-controlled parallel-assignment double-masked randomized clinical trial. METHODS: In this study, patients 18 years or older scheduled for routine phacoemulsification were randomized to a placebo, ketorolac 0.5%, or nepafenac 0.1% and dosed 4 times a day starting 1 day before surgery and continuing for 4 weeks. Spectral-domain macular cube ocular coherence tomography scans measuring central subfield thickness, macular cube volume, and average macular cube thickness were performed at baseline and 1 month postoperatively. The HRQOL metrics were determined with the Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire. RESULTS: Each study group comprised 54 patients. One month postoperatively, although a trend toward significance occurred for nepafenac and ketorolac, analysis of the means of differences showed no statistically significant differences between the 3 study groups (P=.2901). The COMTOL analysis found no difference in tolerability, compliance, side-effect frequency and bother, and effects on HRQOL between ketorolac and nepafenac compared with the placebo. CONCLUSIONS: One month after uneventful phacoemulsification, there was no difference in macular volume between the placebo, ketorolac, and nepafenac. Ketorolac and nepafenac were well tolerated with minimal side-effect profiles. Thus, for patients without risk factors having routine surgery, prophylactic topical NSAIDs are not recommended.