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A prospective, randomized, contralateral eye-controlled study demonstrated that eyes treated with nepafenac 0.1% (Nevanac, Alcon Laboratories) for 4 to 5 days after PRK had significantly greater haze than eyes treated with ketorolac tromethamine 0.4% (Acular LS, Allergan). The study findings and similar experience of other surgeons raise questions about the safety of nepafenac use after surface ablation procedures.
Dr. Trattler presented the findings of a multicenter, randomized, masked, contralateral eye-controlled study comparing nepafenac and ketorolac tromethamine 0.4% (Acular LS, Allergan) for post-PRK treatment in 32 patients.1 The nonsteroidal anti-inflammatory drugs (NSAIDs) were administered three times a day for 4 to 5 days, beginning immediately after surgery. Two of the four investigators (Majmudar and Tauber) enrolled a total of seven patients, in whom the first NSAID drop was placed directly on the cornea prior to application of the bandage contact lens (BCL). Following these cases, the remaining patients received their NSAID drops only after the BCL had been placed.
The two NSAIDs provided comparable symptom control, and no significant difference was noticed between treatments in mean time to healing. Mean haze scores were low for both treatment groups throughout the study, but they were significantly higher in the nepafenac-treated eyes compared with eyes in the ketorolac group at evaluations conducted at 2 weeks and 1, 2, and 3 months after surgery. In addition, responses to questionnaires administered during early follow-up showed that the study patients had a strong preference for the quality of vision in the ketorolac-treated eye.
He continued: "In the large, placebo-controlled clinical trial for FDA approval of ketorolac 0.4%, the drops were placed directly on the stromal bed after surgery and used for up to 4 days. Yet there was no significant difference in mean time to healing or early corneal haze in ketorolac-treated eyes compared with controls. All of these findings should be taken into account when considering use of nepafenac after surface ablation procedures. For those doctors who plan to use nepafenac for pain control with surface ablation, it should be placed on top of the [BCL] and continued for just 2 to 3 days."
The flapless epi-LASIK study to which he referred was halted prematurely after seven patients were enrolled.5 With the aim of enrolling 30 patients, this study, too, was a randomized, masked, contralateral eye-controlled trial comparing nepafenac and ketorolac. In that trial, the initial drops were placed on the stromal bed and then treatment was continued for 5 days.
Four of the first seven patients enrolled experienced significant epithelial healing problems in the nepafenac-treated eyes, so the study was terminated. Analysis of data from the seven patients showed that nepafenac was associated with significantly greater haze and a delay in healing by more than 2 days, on average, although the latter between-group difference was not statistically significant due to the small sample size.