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.