Pseudophakic cystoid macular edema: ketorolac alone vs. ketorolac plus prednisolone.

BACKGROUND

Pseudophakic cystoid macular edema (CME) following phacoemulsification is the most common complication after cataract surgery. Treatment focuses on the reduction of inflammation with topical use of both steroids and NSAIDS. The latter have been shown to be of benefit in chronic CME, but topical NSAID and steroid treatment has only recently been shown to be of benefit in acute CME. We evaluated the use of topically administered NSAIDS and steroids in the management of both acute and chronic pseudophakic CME.

METHODS

This was a prospective double-masked randomized controlled trial. Patients with clinical CME occurring at least 6 weeks following cataract extraction were referred for consideration of enrolment. Patients were excluded if they had Snellen vision better than 20/40, no CME on clinical examination, no CME on angiography, recent use of steroids, preexisting macular disease or diabetic maculopathy on angiography. Ten patients were randomly assigned to receive either 0.5% ketorolac tromethamine plus placebo (four patients) or 0.5% ketorolac tromethamine plus 1% prednisolone acetate (six patients); all 10 completed the study. Patients were assessed at baseline and at 30, 60 and 90 days. Fluorescein angiography was performed at baseline and at 90 days. The primary outcome measures were improvement in Early Treatment Diabetic Retinopathy Study Snellen equivalent vision and resolution of cysts on clinical examination.

RESULTS

No statistically significant differences were found between the two groups in either of the outcome measures at any visit. Subgroup analysis of the patients with chronic CME also showed no significant difference between the two groups.

INTERPRETATION: We found no statistically significant difference in outcome between patients who received ketorolac and those who received ketorolac plus prednisolone for acute or chronic CME. The value of topical steroid therapy for chronic CME remains unproven.