Dishler Laser Institute, Greenwood Village, Colorado.
Slade & Baker Vision Center, Houston, Texas.
Ophthalmology. 2020 Aug;127(8):1020-1034. doi: 10.1016/j.ophtha.2020.01.010. Epub 2020 Jan 15.
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.
Prospective, multicenter clinical trial.
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.
-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.
Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events.
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.
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.
介绍美国食品和药物管理局（FDA）对小切口透镜提取（SMILE）治疗近视和散光的上市前临床试验结果。
前瞻性、多中心临床试验。
本研究共纳入 357 只眼（50 只为单纯近视，307 只为近视合并散光）的 357 例患者。术前球镜度数范围为-1.00 至-10.00 屈光度（D），等效球镜值（MSE）高达-11.50 D，矫正柱镜值高达-3.00 D。
参与者随访 12 个月。报告了 307 只治疗近视合并散光的眼的矫正远视力（CDVA）和未矫正远视力（UDVA）、显现有效屈光的稳定性以及矫正柱镜的矢量分析。报告了所有 357 只眼的不良事件（AE）。
矫正远视力、未矫正远视力、显现有效屈光、散光结果和不良事件。
307 只散光眼中，304 只眼治疗成功。3 只眼因术中吸力丧失而中止手术。MSE 均值从基线时的-5.39±2.30 D 降低至 12 个月时的-0.01±0.24 D。所有眼中，12 个月时 95.3%的眼在 0.50 D 以内达到正视。89.0%的眼 UDVA 达到 20/20 或更好。12 个月随访时，没有眼视力下降 2 行或更多。矫正柱镜从基线时的-1.53±0.70 D 降低至 12 个月时的-0.18±0.31 D。矫正柱镜的平均矫正比值为 0.96±0.16，对于更高的散光尝试矫正，出现轻微欠矫。术中发生 3 例与透镜取出困难和随之发生的角膜瓣撕裂相关的不良事件，但均在术后第 1 天无后遗症地解决。术后期间记录了 8 例不良事件，但均无明显后果。
SMILE 治疗近视和散光安全有效，报道的不良事件对视敏度无明显影响。矫正柱镜的轻微欠矫需要进一步关注。
