Intraindividual comparison of nepafenac 0.3% for the prevention of macular edema after phacoemulsification.

PURPOSE: To compare the antiinflammatory efficacy of topical nepafenac 0.3% for prophylaxis of macular edema after cataract extraction.

SETTING: São Paulo University, São Paulo, Brazil.

DESIGN: Prospective randomized clinical trial.

METHODS: Patients with bilateral cataract were included in this study. Each patient was assigned randomly to receive nepafenac 0.3% drops in 1 eye and a placebo in the fellow eye. The primary outcome measure was the change in the mean spectral-domain optical coherence tomography central subfield thickness 5 weeks postoperatively. The secondary outcome measures were the total macular volume 1, 5, and 12 weeks postoperatively; the percentage of patients in both groups who developed macular edema, and the corrected distance visual acuity within 5 weeks and 12 weeks after cataract surgery.

RESULTS: The study comprised 224 eyes of 112 patients. For all retinal thickness measurements, a significant increase in both groups was detected starting from the first postoperative week until 12 weeks. At 5 weeks, there was a statistically significant difference in central subfield thickness and total macular volume between the nepafenac group and control group (P = .01 and P < .001, respectively). At the fifth postoperative week, no eye in the nepafenac group and 4 eyes (3.57%) in the control group had macula edema, highlighting a trend toward a greater incidence in the control group. The between-group differences in visual outcomes were not statistically significant.

CONCLUSION: Used prophylactically after cataract surgery, nepafenac 0.3% was efficacious in reducing macular thickness compared with a placebo 5 weeks postoperatively, without a difference in final visual acuity.