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.