Xia Fei, Qin Bing, Shang Jianmin, Chen Zhuoyi, Zhou Xueyi, Zhao Jing, Wang Xiaoying, Zhou Xingtao
Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China.
NHC Key Laboratory of Myopia, Fudan University, Shanghai, China.
Front Med (Lausanne). 2020 Nov 16;7:575779. doi: 10.3389/fmed.2020.575779. eCollection 2020.
To evaluate the long-term safety, efficacy, predictability, and stability of small incision lenticule extraction (SMILE) for the treatment of high myopia and myopic astigmatism >-10.0 D. This was a prospective study that incorporated 35 consecutive patients (35 eyes) undergoing SMILE from September 2015 to March 2016. These patients had a mean preoperative spherical equivalent refraction of -10.06 ± 0.64 D. Patients were followed over a 4-year period and assessed for outcomes including uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, and corneal topography. At 4 years post-SMILE, respective efficacy and safety indices were 1.01 ± 0.19 and 1.07 ± 0.15. In total, 97% of operated eyes achieved an UDVA of 20/25 or better. ≥1 line was gained for 9 eyes (26%), with 25 eyes (71%) remaining stable. Twenty-four (69%) and 33 (94%) eyes, respectively, were within ±0.50 D and ±1.0 D of target refraction. From 3 months to 4 years postoperatively, a mean refractive regression of -0.22 D (-0.06 D per year) was detected, whereas no significant changes in mean corneal back curvature or posterior central elevation were detected ( = 0.617 and 0.754, respectively). We detected significant increases in higher-order aberrations (HOAs) of the anterior and total cornea (all < 0.001), with spherical aberrations and vertical coma being particularly common, whereas posterior corneal HOA remained fairly stable (all < 0.05). SMILE is a safe, effective, predictable, and stable means of correcting high myopia and myopic astigmatism over a 4-year postoperative period.
评估小切口透镜切除术（SMILE）治疗高度近视和近视散光>-10.0 D的长期安全性、有效性、可预测性和稳定性。这是一项前瞻性研究，纳入了2015年9月至2016年3月连续接受SMILE手术的35例患者（35只眼）。这些患者术前平均等效球镜度为-10.06±0.64 D。对患者进行了4年的随访，并评估了包括未矫正远视力（UDVA）、矫正远视力（CDVA）、显验光和角膜地形图等结果。SMILE术后4年，相应的有效性和安全性指标分别为1.01±0.19和1.07±0.15。总体而言，97%的手术眼达到了20/25或更好的UDVA。9只眼（26%）提高了≥1行，25只眼（71%）保持稳定。分别有24只眼（69%）和33只眼（94%）的屈光度数在目标屈光度的±0.50 D和±1.0 D范围内。术后3个月至4年，检测到平均屈光回退-0.22 D（每年-0.06 D），而平均角膜后表面曲率或后中央高度未检测到显著变化（分别为 = 0.617和0.754）。我们检测到前角膜和全角膜的高阶像差（HOA）显著增加（所有 < 0.001），其中球差和垂直彗差尤为常见，而后角膜HOA保持相当稳定（所有 < 0.05）。SMILE是一种在术后4年内矫正高度近视和近视散光的安全、有效、可预测且稳定的方法。
