Visual and Refractive Outcomes of Femtosecond Lenticule Extraction and Small-Incision Lenticule Extraction for Myopia
Visual and Refractive Outcomes of Femtosecond Lenticule Extraction and Small-Incision Lenticule Extraction for Myopia
复制标题
DOI：
10.1016/j.ajo.2013.08.011
复制
发表时间：
2014-01-01
影响因子：
4.2
通讯作者：
Kobashi, Hidenaga
中科院分区：
文献类型：
--
作者：
Kamiya, Kazutaka;Shimizu, Kimiya;Kobashi, Hidenaga
目得：比较飞秒激光晶状体摘除术（FLEx）和小切口晶状体摘除术（SMILE）治疗近视眼的视力和屈光结果。设计：前瞻性、随机、设盲的个体内比较临床试验。方法：本研究评价了26例等效球镜为-4.19 +/-1.65屈光度（D）的连续患者的52只眼（平均标准+/-差），其中1只眼睛接受了FLEx，另一只眼睛接受了SMILE。在术前、术后1周、1个月、3个月和6个月，我们评估了两种手术技术的安全性、有效性、可预测性、稳定性和不良事件。FLEx组的LogMAR裸眼视力和矫正远视力分别为-0.17 +/- 0.10、-0.20 +/- 0.07和-0.15 +/- 0.10，术后6个月，SMILE组为-0.19 +/- 0.07。在FLEx和SMILE组中，术后6个月，分别有96%和100%的眼睛在目标等效球镜矫正的0.5 D范围内。FLEx和SMILE组从1周至6个月的明显屈光变化分别为-0.02 +/- 0.39 D和0.00 +/- 0.30 D。在FLEx或SMILE group.CONCLUSIONS：在整个6个月的观察期内，FLEx和SMILE在近视矫正方面均表现良好。在安全性、有效性、可预测性和稳定性方面，FLEx可能基本上等同于SMILE，这表明是否存在提升皮瓣不会显著影响这些视力和屈光结果。(C)2014年，Elsevier Inc. All rights reserved.
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. (C) 2014 by Elsevier Inc. All rights reserved.