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A prospective randomized trial of topical soluble 0.1% indomethacin versus 0.1% diclofenac versus placebo for the control of pain following excimer laser photorefractive keratectomy.

Author(s): Assouline M, Renard G, Arne JL, David T, Lasmolles C, Malecaze F, Pouliquen YJ

Affiliation(s): Department of Ophthalmology, Hotel-Dieu de Paris, INSERM U86, University of Paris VI, Medical School, France.

Publication date & source: 1998-05, Ophthalmic Surg Lasers., 29(5):365-74.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND AND OBJECTIVE: To compare the safety and efficacy of topical nonsteroidal antiinflammatory drugs (NSAIDs) for the control of pain after excimer laser photorefractive keratectomy (PRK). PATIENTS AND METHODS: One hundred twenty informed patients were enrolled in a double-masked, randomized, comparative study and assigned to either 0.1% indomethacin, 0.1% diclofenac, or placebo treatment. Subjective postoperative pain, symptoms, re-epithelialization rate, and systemic medications were monitored for 2 days following photoablation. RESULTS: Compared with the placebo, 0.1% indomethacin solution significantly reduced pain on the day of surgery (D0) (P < .05), whereas 0.1% diclofenac did not reach a significant level (P = .46). At D0, analgesic intake by the oral route was significantly greater in the placebo group (P < .05). Severe photophobia was significantly less frequent in the group treated with 0.1% indomethacin (P < .05). Corneal wound healing was significantly delayed in the patients treated with 0.1% diclofenac at D2 as compared with other groups (P = .04). CONCLUSION: Topical 0.1% indomethacin solution helps control the pain induced by excimer laser photoablation of the cornea without any detrimental effect to the corneal epithelial wound healing.

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