Double-masked comparison of ketorolac tromethamine 0.4% versus nepafenac sodium 0.1% for postoperative healing rates and pain control in eyes undergoing surface ablation

Abstract

Purpose: Determine the degree of postoperative pain and rate of healing in eyes treated with either ketorolac tromethamine 0.4% (Acular LS) or nepafenac sodium 0.1% (Nevanac) after flapless surface ablation [epi-laser in situ keratomileusis (LASIK)].

Methods: Prospective, randomized, double-masked, paired-eye comparison. Patients undergoing flapless surface ablation were randomized to receive ketorolac in 1 eye and nepafenac in the other. Drops were instilled immediately after the surgical procedure, and patients continued to instill the masked drops 3 times daily for 5 days. Study follow-up visits were at days 1 and 5 postoperatively. Patients were queried by phone regarding their level of pain at 5 hours postoperatively and on days 2, 3, and 4. Outcome measures included postoperative pain levels including need for additional rescue medications, rate of healing, and adverse events.

Results: Although the original target population was 60 eyes of 30 patients, this study was halted after only 14 eyes of 7 patients because of concern for patient safety, because most patients in 1 arm developed haze. Eyes treated with nepafenac healed at a slower rate than eyes treated with ketorolac in 57% of patients. Mean time to healing was 5.7 +/- 1.1 days with ketorolac and 7.9 +/- 2.1 days with nepafenac (P = 0.066). Moreover, eyes treated with nepafenac exhibited statistically significant greater mean hazing scores at week 2 (P = 0.024) and month 1 (P = 0.039). Throughout the study, a greater percentage of nepafenac-treated eyes exhibited haze than did ketorolac-treated eyes. This difference was statistically significant at week 2 (P = 0.005) and month 1 (P = 0.039). Patients reported significantly more pain in nepafenac-treated eyes at day 3 when pain was at its peak (P = 0.046).

Conclusions: In patients undergoing epi-LASIK, a statistically significant trend postoperative toward increased corneal haze was seen with nepafenac compared with ketorolac. Nepafenac therapy resulted in a non-statistically significant trend toward delayed healing. The study was halted because of safety concerns.