Seyed-Farzad Mohammadi1, Elham Ashrafi2, Nima Norouzi1, Tahereh Abdolahinia1, Mohsen Mir-AbouTalebi1, Mahmoud Jabbarvand1. 1. From Tehran University of Medical Sciences, International Campus (Ashrafi), the Eye Research Center (Mohammadi, Ashrafi, Norouzi, Mir-AbouTalebi, Jabbarvand), Farabi Eye Hospital, Tehran University of Medical Sciences, and the Noor Ophthalmology Research Center (Abdolahinia), Noor Eye Hospital, Tehran, Iran. 2. From Tehran University of Medical Sciences, International Campus (Ashrafi), the Eye Research Center (Mohammadi, Ashrafi, Norouzi, Mir-AbouTalebi, Jabbarvand), Farabi Eye Hospital, Tehran University of Medical Sciences, and the Noor Ophthalmology Research Center (Abdolahinia), Noor Eye Hospital, Tehran, Iran. Electronic address: el.ashrafi@gmail.com.
Abstract
PURPOSE: To assess the effect of mitomycin-C (MMC) on the tear film, corneal biomechanics, and surface irregularity in surface ablation (photorefractive keratectomy [PRK]) for low to moderate myopia. SETTING:Refractive Surgery Unit, Farabi Eye Hospital, Tehran, Iran. DESIGN: Double-masked randomized clinical trial. METHODS: In patients with spherical equivalent myopia of -0.75 to -3.87 diopters (D) and astigmatism up to -1.75 D, the first eye was randomly assigned to the application of MMC 0.02% or a balanced salt solution for 15 seconds. The fellow eye received the alternate in a masked fashion after excimer photoablation. RESULTS: The study enrolled 60 patients. In fellow eyes, the changes in the tear-film index were comparable 1 month and 6 months postoperatively. There was no significant difference in changes in total higher-order aberrations, spherical aberration, coma, or Q values (Pentacam HR) between fellow eyes at 1 month and 6 months. There was a trend toward a higher asymmetry index at 1 month; however, a statistically significant drop was observed at 6 months in the MMC group (P<.01). It was hypothesized that stromal remodeling was delayed, but better, in MMC-treated eyes. No haze was recorded at 6 months in either group. CONCLUSION: Use of MMC in PRK did not appear to contribute significantly to surface irregularity, transient tear-film dysfunction, or biomechanical weakening of the cornea compared with PRK without MMC. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To assess the effect of mitomycin-C (MMC) on the tear film, corneal biomechanics, and surface irregularity in surface ablation (photorefractive keratectomy [PRK]) for low to moderate myopia. SETTING: Refractive Surgery Unit, Farabi Eye Hospital, Tehran, Iran. DESIGN: Double-masked randomized clinical trial. METHODS: In patients with spherical equivalent myopia of -0.75 to -3.87 diopters (D) and astigmatism up to -1.75 D, the first eye was randomly assigned to the application of MMC 0.02% or a balanced salt solution for 15 seconds. The fellow eye received the alternate in a masked fashion after excimer photoablation. RESULTS: The study enrolled 60 patients. In fellow eyes, the changes in the tear-film index were comparable 1 month and 6 months postoperatively. There was no significant difference in changes in total higher-order aberrations, spherical aberration, coma, or Q values (Pentacam HR) between fellow eyes at 1 month and 6 months. There was a trend toward a higher asymmetry index at 1 month; however, a statistically significant drop was observed at 6 months in the MMC group (P<.01). It was hypothesized that stromal remodeling was delayed, but better, in MMC-treated eyes. No haze was recorded at 6 months in either group. CONCLUSION: Use of MMC in PRK did not appear to contribute significantly to surface irregularity, transient tear-film dysfunction, or biomechanical weakening of the cornea compared with PRK without MMC. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
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