Efficacy of diclofenac eyedrops in preventing postoperative inflammation and long-term cystoid macular edema. Italian Diclofenac Study Group.

PURPOSE: To compare the efficacy and tolerance of diclofenac 0.1% eyedrops with a regimen that included a brief course of steroids in the treatment of postoperative inflammation after extracapsular cataract surgery and posterior chamber intraocular lens implantation. A second objective was to compare the efficacy of diclofenac 0.1% eyedrops in the same patients and control group in preventing cystoid macular edema (CME).

SETTING: Eight university/hospital centers and one company in Italy.

METHODS: The multicenter, controlled, randomized, prospective, double-blind study included 281 patients. All were evaluated at baseline, at surgery, and after 1, 5, 36, 67, and 140 days. Postoperative inflammation was measured by the clinical assessment of inflammation: conjunctival hyperemia, ciliary flush, Tyndall effect, and cells in the anterior chamber. Fluorescein angiography was performed to evaluate the presence/absence of CME before surgery and after 36 and 140 days.

RESULTS: During follow-up, no differences in intraoperative pressure were observed within or between groups or between operated and fellow eyes. No statistically significant between-group differences in postoperative inflammation were found. After 36 days, angiographic CME was found in 9 patients (6.43%) in the diclofenac group and 20 (15.15%) in the control group (P = .033) with a relative risk for developing CME of 0.40 (CI95 0.19 to 0.84). At the end of follow-up, it was found in 4 patients in the diclofenac group (3.31%) and 10 (9.26%) in the control group (P = .05) with a relative risk of 0.36 (CI95 0.12 to 0.90).

CONCLUSION: Diclofenac sodium was as effective as the control regimen in controlling postoperative inflammation after cataract surgery. It also had a protective effect on the development of angiographic CME after 36 and 140 days.