PURPOSE To compare U.S. Food and Drug Administration (FDA)-reported visual and refractive outcomes following surgical correction of myopia and myopic astigmatism using the Visian Toric Implantable Collamer Lens (STAAR Surgical, Monrovia, CA) (Toric ICL), small incision lenticule extraction (SMILE), and topography-guided laser in situ keratomileusis (TG-LASIK). METHODS FDA summary of safety and effectiveness data (SSED) were analyzed for each of the three platforms. Primary outcomes measured were efficacy, safety, stability, and accuracy of refractive correction. Stratified mean refractive spherical equivalent (MRSE) data were assessed. RESULTS One hundred twenty-four Toric ICL patients (210 eyes), 357 SMILE patients (357 eyes), and 212 TG-LASIK patients (249 eyes) were included. SMILE eyes had a significant improvement in postoperative uncorrected distance visual acuity with respect to preoperative corrected distance visual acuity from 3 to 12 months (P < .001), whereas TG-LASIK had no further improvement from 3 to 12 months (P = .79). For preoperative MRSE greater than 10.00 diopters (D), there was a significant difference in the percentage of eyes achieving postoperative MSRE within ±0.50 D between Toric ICL (66%) and SMILE (100%) (P < .001). SMILE was consistently more accurate than Toric ICL for cylinder within ±0.25 D (P < .001), ±0.50 D (P < .001), and ±1.00 D (P = .0014). CONCLUSIONS All three platforms analyzed in this study had excellent efficacy, safety, stability, and accuracy. Stratified analysis revealed that SMILE may be comparable to Toric ICL for patients with high myopia or myopic astigmatism, and SMILE may have a longer visual recovery compared to TG-LASIK than previously indicated. [J Refract Surg. 2019;35(11):699-706.].

中文翻译：

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FDA报告的复曲面ICL镜片，SMILE和地形学指导的LASIK矫正近视和近视散光的视觉和屈光结果比较。

目的比较美国食品和药物管理局（FDA）报告的使用Visian Toric植入式散光镜（STAAR Surgical，Monrovia，CA）（Toric ICL），小切口小孔摘除术（ SMILE）和地形导向的激光原位角膜磨镶术（TG-LASIK）。方法对三个平台中的每个平台，分析FDA安全性和有效性数据摘要（SSED）。测得的主要结局为疗效，安全性，稳定性和屈光矫正的准确性。评估了分层平均屈光球当量（MRSE）数据。结果包括124例Toric ICL患者（210眼），357例SMILE患者（357眼）和212例TG-LASIK患者（249眼）。与3到12个月的术前矫正远视力相比，SMILE眼的术后未矫正远视力有显着改善（P <.001），而TG-LASIK从3到12个月无进一步改善（P = .79） ）。对于术前MRSE大于10.00屈光度（D）的患者，Toric ICL（66％）和SMILE（100％）之间在±0.50 D之内达到术后MSRE的眼睛百分比存在显着差异（P <.001）。对于气缸在±0.25 D（P <.001），±0.50 D（P <.001）和±1.00 D（P = .0014）之内的圆柱体，SMILE始终比Toric ICL更准确。结论本研究中分析的所有三个平台均具有出色的功效，安全性，稳定性和准确性。分层分析显示，对于高度近视或近视散光患者，SMILE可能与Toric ICL相当，并且与TG-LASIK相比，SMILE的视觉恢复时间更长。[J Refract Surg。2019; 35（11）：699-706。]。