The effect of diclofenac sodium ophthalmic solution on intraocular pressure following cataract extraction.

Ninety-two nonglaucomatous patients undergoing extracapsular cataract extraction with implantation of a posterior chamber intraocular lens by residents at a Veterans hospital were randomized in double-masked fashion to receive either a topical nonsteroidal antiinflammatory agent, diclofenac sodium 0.1%, or a placebo consisting of vehicle only. One drop of placebo or diclofenac sodium 0.1% was administered on an inpatient basis by trained staff every 6 hours for three doses, starting the afternoon prior to surgery. A further drop was given at 90, 60, 30, and 15 minutes before the operation. Starting 24 hours after surgery, all patients received diclofenac sodium 0.1%. All patients remained hospitalized for 72 hours postoperatively. Mean baseline intraocular pressure (IOP) was 14.0 and 14.1 mm Hg in the diclofenac and placebo groups, respectively. IOP rose 8.6 mm Hg in both groups at 6 hours after surgery. At 24 hours, the mean IOP elevation from baseline was 11.3 mm Hg in the diclofenac group and 9.6 mm Hg in the placebo group (P = .47). Within the first 24 hours, IOP spiked more than 10 mm Hg in 57% (26/46) of the diclofenac patients and in 54% (25/46) of the placebo patients. These results suggest that diclofenac sodium 0.1% drops affect neither the incidence nor the height of IOP elevation following cataract surgery.

RCT Entities:   Population Interventions Outcomes