Purpose

To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism.

Design

Prospective, multicenter clinical trial.

Participants

The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between –1.00 and –10.00 diopters (D), with manifest spherical equivalent (MSE) of up to –11.50 D and refractive cylinder of up to –3.00 D.

Methods

-Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes.

Main Outcome Measures

Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events.

Results

Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from –5.39±2.30 D at baseline to –0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from –1.53±0.70 D at baseline to –0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences.

Conclusions

Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.

中文翻译：

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小切口小孔摘除术（SMILE），用于矫正散光的近视：美国食品药品监督管理局上市前批准临床试验的结果。

目的

展示美国食品药品监督管理局上市前批准的小切口小孔镜摘除术（SMILE）用于矫正近视和散光的临床试验结果。

设计

前瞻性，多中心临床试验。

参加者

该研究包括357例接受SMILE治疗的患者的357只眼睛（近视50例，散光近视307例）。术前球的范围在–1.00至–10.00屈光度（D）之间，明显的球当量（MSE）最高为–11.50 D，屈光柱面最高为–3.00D。

方法

-参与者随访了12个月。提出了307例散光近视眼的矫正远视力（CDVA）和未矫正远视力（UDVA），明显屈光的稳定性以及屈光力的载体分析。呈现了所有357眼的不良事件（AE）。

主要观察指标

矫正远视力，未矫正远视力，明显屈光，散光结果和不良事件。

结果

在这项研究中纳入的307散光眼中，有304眼得到了成功治疗。在3只眼中，由于术中吸力减退而中止了手术。平均MSE从基线时的–5.39±2.30 D降至12个月时的–0.01±0.24D。在12个月内，所有眼睛中有95.3％处于正视眼0.50 D以内。UDVA为20/20或更高的眼睛百分比为89.0％。在12个月的随访中未观察到2株或更多株CDVA的损失。屈光柱从基线时的–1.53±0.70 D降低至12个月时的–0.18±0.31D。屈光柱的平均矫正率为0.96±0.16，对于较高的像散矫正尝试，轻微矫正是明显的。发生了3次术中不良事件，这些不良事件与难以摘除的小球和由此导致的帽裂有关，并且在术后第1天全部消失而没有后遗症。

结论

小切口小孔摘除术治疗近视和散光是安全有效的，并且已报道的不良事件对视敏度没有显着影响。屈光镜筒的轻微欠矫需要进一步注意。