Diclofenac drops to treat inflammation after cataract surgery

Purpose: To compare the anti-inflammatory effect of topical diclofenac sodi um 0.1% in a fixed combination with gentamicin 0.3% to the anti-inflammator y 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 Hopital Jules Gonin, Department of Ophthalmology, University of Lausanne, Lausanne, Switz erland. Methods: Inclusion of patients scheduled for extracapsular cataract extract ion (ECCE) with implantation of an all PMMA intraocular lens (IOL), Double- masked comparison of post-operative inflammation in two randomized treatmen t groups: (1) fixed diclofenac sodium 0.1%/gentamicin 0.3% and vehicle drop s 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 a nd 3X/day until day 28 and gentamicin 0.3% drops 4X/day until day 12-14, An terior chamber flare and cells, measured by laser flare-cell photometry, we re analyzed as the primary outcomes. Results: Eighty-seven patients were recruited, 45 being assigned to the dic lofenac group and 42 to the dexamethasone control group. Diclofenac was sig nificantly better than dexamethasone at controlling flare at day 3 (p less than or equal to 0.01) and day 12-14 (p less than or equal to 0.002). Mean anterior chamber cells were also significantly lower at day 12-14 (p less t han or equal to 0.021) and day 28 (p less than or equal to 0.012). The comm onest adverse event was transient punctate keratitis, which occurred in 15 diclofenac and 3 dexamethasone patients. Conclusions: While both treatments were effective at controlling post-opera tive inflammation, the diclofenac-gentamicin combination followed by diclof enac alone was significantly better at suppressing flare and cells but show ed a slightly higher incidence of punctate keratitis and eye discomfort.