Kazutaka Kamiya1, Kimiya Shimizu2, Akihito Igarashi2, Hidenaga Kobashi2. 1. Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan. Electronic address: kamiyak-tky@umin.ac.jp. 2. Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan.
Abstract
PURPOSE: To compare the visual and refractive outcomes of femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) in eyes with myopia. DESIGN: Prospective, randomized, masked clinical trial with intraindividual comparison. METHODS: This study evaluated 52 eyes of 26 consecutive patients with spherical equivalents of -4.19 ± 1.65 diopters (D) (mean ± standard deviation) who underwent FLEx in 1 eye and SMILE in the other eye by randomized assignment. Before surgery, and 1 week and 1, 3, and 6 months after surgery, we assessed safety, efficacy, predictability, stability, and adverse events of the 2 surgical techniques. RESULTS:LogMAR uncorrected and corrected distance visual acuity was, respectively, -0.17 ± 0.10, -0.20 ± 0.07 in the FLEx group and -0.15 ± 0.10, -0.19 ± 0.07 in the SMILE group 6 months postoperatively. In the FLEx and SMILE groups 6 months postoperatively, 96% and 100% of eyes, respectively, were within 0.5 D of the targeted spherical equivalent correction. Changes of -0.02 ± 0.39 D and 0.00 ± 0.30 D occurred in manifest refraction from 1 week to 6 months in the FLEx and SMILE groups, respectively. No clinically significant complications occurred in the FLEx or the SMILE group. CONCLUSIONS: Both FLEx and SMILE performed well in the correction of myopia throughout the 6-month observation period. FLEx may be essentially equivalent to SMILE in terms of safety, efficacy, predictability, and stability, suggesting that the presence or absence of lifting the flap does not significantly affect these visual and refractive outcomes.
RCT Entities:
PURPOSE: To compare the visual and refractive outcomes of femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) in eyes with myopia. DESIGN: Prospective, randomized, masked clinical trial with intraindividual comparison. METHODS: This study evaluated 52 eyes of 26 consecutive patients with spherical equivalents of -4.19 ± 1.65 diopters (D) (mean ± standard deviation) who underwent FLEx in 1 eye and SMILE in the other eye by randomized assignment. Before surgery, and 1 week and 1, 3, and 6 months after surgery, we assessed safety, efficacy, predictability, stability, and adverse events of the 2 surgical techniques. RESULTS: LogMAR uncorrected and corrected distance visual acuity was, respectively, -0.17 ± 0.10, -0.20 ± 0.07 in the FLEx group and -0.15 ± 0.10, -0.19 ± 0.07 in the SMILE group 6 months postoperatively. In the FLEx and SMILE groups 6 months postoperatively, 96% and 100% of eyes, respectively, were within 0.5 D of the targeted spherical equivalent correction. Changes of -0.02 ± 0.39 D and 0.00 ± 0.30 D occurred in manifest refraction from 1 week to 6 months in the FLEx and SMILE groups, respectively. No clinically significant complications occurred in the FLEx or the SMILE group. CONCLUSIONS: Both FLEx and SMILE performed well in the correction of myopia throughout the 6-month observation period. FLEx may be essentially equivalent to SMILE in terms of safety, efficacy, predictability, and stability, suggesting that the presence or absence of lifting the flap does not significantly affect these visual and refractive outcomes.