P K Kaiser1, R Pineda. 1. Division of Ophthalmology A31, Cleveland Clinic Foundation, OH 44195, USA.
Abstract
OBJECTIVE: To evaluate the effectiveness of an ophthalmic nonsteroidal anti-inflammatory drug (NSAID) in the treatment of noninfected, non-contact lens-related, traumatic corneal abrasions and no pressure patch. DESIGN: A single-center, randomized, double-masked, placebo-controlled study. PARTICIPANTS: One hundred patients with noninfected, non-contact lens-related, traumatic or foreign body removal-related corneal abrasions less than 36 hours in duration. INTERVENTION: All patients received a cycloplegic drop and erythromycin or polymyxin B (Polysporin Ophthalmic Ointment, Burroughs Wellcome, Research Triangle Park, NC). Patients were then randomized to receive either ketorolac tromethamine 0.5% ophthalmic solution or control vehicle drops. MAIN OUTCOME MEASURES: The main outcome measures were six subjective symptoms monitored daily, evaluation of corneal abrasion, and determination of adverse events. Long-term complications were determined 3 to 8 months after randomization. RESULTS:Twelve patients were excluded from the study. One day after randomization, patients receiving ketorolac tromethamine 0.5% ophthalmic solution noted significantly decreased levels of pain (P < 0.002), photophobia (P < 0.009), and foreign body sensation (P < 0.003) as compared with the control vehicle group. In addition, the time to resumption of normal activities was shorter in the group who received ketorolac tromethamine 0.5% ophthalmic solution (P < 0.001). There was no statistical difference in the amount of tearing, healing time, acuity changes, or complication rates between the two groups. CONCLUSIONS:Ketorolac tromethamine 0.5% ophthalmic solution provides increased patient comfort without clinical adverse effects when used as adjunctive therapy in the treatment of noninfected, non-contact lens-related, traumatic corneal abrasions.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of an ophthalmic nonsteroidal anti-inflammatory drug (NSAID) in the treatment of noninfected, non-contact lens-related, traumatic corneal abrasions and no pressure patch. DESIGN: A single-center, randomized, double-masked, placebo-controlled study. PARTICIPANTS: One hundred patients with noninfected, non-contact lens-related, traumatic or foreign body removal-related corneal abrasions less than 36 hours in duration. INTERVENTION: All patients received a cycloplegic drop and erythromycin or polymyxin B (Polysporin Ophthalmic Ointment, Burroughs Wellcome, Research Triangle Park, NC). Patients were then randomized to receive either ketorolac tromethamine 0.5% ophthalmic solution or control vehicle drops. MAIN OUTCOME MEASURES: The main outcome measures were six subjective symptoms monitored daily, evaluation of corneal abrasion, and determination of adverse events. Long-term complications were determined 3 to 8 months after randomization. RESULTS: Twelve patients were excluded from the study. One day after randomization, patients receiving ketorolac tromethamine 0.5% ophthalmic solution noted significantly decreased levels of pain (P < 0.002), photophobia (P < 0.009), and foreign body sensation (P < 0.003) as compared with the control vehicle group. In addition, the time to resumption of normal activities was shorter in the group who received ketorolac tromethamine 0.5% ophthalmic solution (P < 0.001). There was no statistical difference in the amount of tearing, healing time, acuity changes, or complication rates between the two groups. CONCLUSIONS:Ketorolac tromethamine 0.5% ophthalmic solution provides increased patient comfort without clinical adverse effects when used as adjunctive therapy in the treatment of noninfected, non-contact lens-related, traumatic corneal abrasions.