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Review of the FDA Premarket Approval Studies Comparing SMILE and LASIK.
Journal of Refractive Surgery ( IF 2.9 ) Pub Date : 2020-02-01 , DOI: 10.3928/1081597x-20191212-01
Montserrat Garcia-Gonzalez , Juan Gros-Otero , Isabel Rodriguez-Perez , Miguel A. Teus 1
Affiliation  

We have read with interest the review by Schallhorn et al.1 comparing the results obtained with small incision lenticule extraction (SMILE)2 and two excimer laser–based procedures in the correction of myopia with astigmatism.3,4 The problem with the conclusions of this article is that the populations in the different studies submitted to the U.S. Food and Drug Administration had significant differences in some preoperative features that may be clinically relevant (ie, amount of preoperative cylinder and corrected distance visual acuity [CDVA]).2–4 In addition, the postoperative uncorrected

中文翻译:

FDA比较SMILE和LASIK的上市前批准研究。

我们感兴趣地阅读了Schallhorn等人的评论[1],比较了小切口小孔镜提取(SMILE)2和两种基于准分子激光的程序在矫正散光近视中获得的结果[3,4]。本文认为,提交给美国食品和药物管理局的不同研究中的人群在某些可能与临床相关的术前特征方面存在显着差异(即术前柱面量和矫正远视力[CDVA])。2-4另外,术后未矫正
更新日期:2020-02-10
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