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≤0.01) and day 12–14 (p≤0.002). Mean anterior chamber cells were also significantly lower at day 12–14 (p≤0.021) and day 28 (p≤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.