Xia Fei, Shen Yang, Han Tian, Zhao Jing, Xu Haipeng, Zhou Xingtao
Department of Ophthalmology and Optometry, Eye and ENT Hospital, Fudan University, Shanghai, China.
NHC Key Laboratory of Myopia (Fudan University), Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China.
J Ophthalmol. 2020 Apr 22;2020:3825864. doi: 10.1155/2020/3825864. eCollection 2020.
To investigate the long-term outcomes of refraction, corneal tomography, and wavefront aberrations after small incision lenticule extraction (SMILE) for moderate and high myopia.
Prospective, nonconsecutive case series. A total of 26 patients (26 eyes) who underwent SMILE from May 2010 to March 2013 at the Fudan University Eye and ENT Hospital (Shanghai, China) were enrolled. The periods of follow-up were 1 month, 1 year, 5 years, and 7 years after surgery. The routine eye examinations included uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, and corneal tomography.
All surgeries were executed without any complications. At the final visit, an UDVA of 20/20 or better was achieved in 26 eyes (100%) and 11 eyes (42%) exhibited no change in CDVA. 9 eyes (35%) gained one line, 6 eyes (23%) gained two lines, and no eyes lost CDVA. 24 eyes (92%) and 26 eyes (100%) were within ±0.5 D and ±1.00 D of the target refraction, respectively. A mean refractive regression of -0.17 D was observed between 1 month and 7 years postoperatively. Mean corneal front curvature (MCFC) was significantly decreased between pre- and post-SMILE surgery ( < 0.0001). Higher-order aberrations (HOAs) and vertical coma were significantly increased after SMILE compared to those measured before surgery (all < 0.001). There were no significant differences in trefoil and spherical aberration between pre- and post-SMILE surgery (all > 0.05).
SMILE is an effective, safe, and stable procedure for moderate and high myopia, with relatively constant corneal stability and wavefront aberrations. This trial is registered with ChiCTR-ONRC-13003114.
探讨小切口透镜切除术（SMILE）治疗中高度近视后屈光、角膜地形图及波前像差的长期结果。
前瞻性、非连续性病例系列研究。纳入2010年5月至2013年3月在复旦大学附属眼耳鼻喉科医院（中国上海）接受SMILE手术的26例患者（26只眼）。随访时间为术后1个月、1年、5年和7年。常规眼部检查包括裸眼远视力（UDVA）、矫正远视力（CDVA）、显验光和角膜地形图。
所有手术均无并发症发生。末次随访时，26只眼（100%）的UDVA达到20/20或更好，11只眼（42%）的CDVA无变化。9只眼（35%）提高了一行，6只眼（23%）提高了两行，无眼CDVA下降。24只眼（92%）和26只眼（100%）分别在目标屈光度的±0.5 D和±1.00 D范围内。术后1个月至7年观察到平均屈光回退-0.17 D。SMILE手术前后平均角膜前表面曲率（MCFC）显著降低（<0.0001）。与术前测量相比，SMILE术后高阶像差（HOAs）和垂直彗差显著增加（均<0.001）。SMILE手术前后三叶草像差和球差无显著差异（均>0.05）。
SMILE是一种治疗中高度近视有效、安全且稳定的手术，角膜稳定性和波前像差相对恒定。本试验已在中国临床试验注册中心注册，注册号为ChiCTR-ONRC-13003114。
