Prophylaxis of pseudophakic cystoid macular edema with topical indomethacin.

A prospective double-masked study of 500 patients was performed to assess the effect of topical indomethacin on the angiographic incidence of cystoid macular edema (CME) in patients undergoing intraocular lens implant surgery. All patients received either topical indomethacin or placebo before surgery and for nine months after surgery. All patients underwent planned extracapsular extraction (PEC) or posterior chamber phacoemulsification (PC-KPE). Implantation of a posterior chamber lens and a primary capsulotomy were performed in all cases. All cases received postoperative topical corticosteroids. Of the 500 cases, 390 (78%) underwent fluorescein angiography; most were performed between 2 1/2 and 5 months after surgery. The incidence of angiographically confirmed CME was significantly higher in the placebo-treated patients as compared to those treated with indomethacin (18.5% vs 9.6%; P = 0.04). Patients 60 years of age or older had a significantly higher incidence of CME than younger individuals (15% vs. 3.4%; P = 0.03). When corrected for the effects of drug regimen and age, by means of multiple logistic regression, there was no significant correlation between procedure (PEC vs. PC-KPE) and CME rate (P = 0.62). There was no significant difference in postoperative visual acuity between the indomethacin- and placebo-treated patients (P = 0.65).

RCT Entities:   Population Interventions Outcomes