Diclofenac drops to treat inflammation after cataract surgery.

PURPOSE: To compare the anti-inflammatory effect of topical diclofenac sodium 0.1% in a fixed combination with gentamicin 0.3% to the anti-inflammatory effect of dexamethasone phosphate 0.1% in a prospective randomized double-masked double-dummy study in patients undergoing cataract surgery.

SETTING: Trial performed from June 1991 to April 1992 at the Hôpital Jules Gonin, Department of Ophthalmology, University of Lausanne, Lausanne, Switzerland.

METHODS: Inclusion of patients scheduled for extracapsular cataract extraction (ECCE) with implantation of an all PMMA intraocular lens (IOL). Double-masked comparison of post-operative inflammation in two randomized treatment groups: (1) fixed diclofenac sodium 0.1%/gentamicin 0.3% and vehicle drops 4X/day until day 12-14 and diclofenac sodium 0.1% 3X/day until day 28. (2) dexamethasone phosphate 0.1% drops 4X/day until postoperative day 12-14 and 3X/day until day 28 and gentamicin 0.3% drops 4X/day until day 12-14. Anterior chamber flare and cells, measured by laser flare-cell photometry, were analyzed as the primary outcomes.

RESULTS: Eighty-seven patients were recruited, 45 being assigned to the diclofenac group and 42 to the dexamethasone control group. Diclofenac was significantly better than dexamethasone at controlling flare at day 3 (p< or =0.01) and day 12-14 (p< or =0.002). Mean anterior chamber cells were also significantly lower at day 12-14 (p< or =0.021) and day 28 (p< or =0.012). The commonest adverse event was transient punctate keratitis, which occurred in 15 diclofenac and 3 dexamethasone patients.

CONCLUSIONS: While both treatments were effective at controlling post-operative inflammation, the diclofenac-gentamicin combination followed by diclofenac alone was significantly better at suppressing flare and cells but showed a slightly higher incidence of punctate keratitis and eye discomfort.