Key Lab of Myopia, Ministry of Health, Department of Ophthalmology, EYE & ENT Hospital of Fudan University, Shanghai, China.
Department of Medicine, The Mount Sinai Hospital, New York, New York, USA.
Acta Ophthalmol. 2019 May;97(3):e373-e380. doi: 10.1111/aos.14017. Epub 2019 Jan 11.
To compare visual outcomes and aberration outcomes in small incision lenticule extraction (SMILE) versus femtosecond laser LASIK (FS-LASIK).
This prospective, comparative, nonrandomized clinical study included 68 eyes of 37 patients receiving SMILE and 55 eyes of 30 patients receiving FS-LASIK between December 2011 and January 2013 at the Fudan University Eye and ENT Hospital (Shanghai, People's Republic of China). Patients were followed up at 3, 6 months and 5 years after surgery. Main outcome measurements included uncorrected (UDVA) and corrected (CDVA) distance visual acuity, manifest refraction, central corneal thickness (CCT), total corneal refractive power (TCRP) and wavefront aberrations.
About 98% (49/50) of treated eyes in the SMILE group and 95% (39/41) in the FS-LASIK group had a postoperative logMAR UDVA of 0 or better. Spherical equivalent (SE) after 5 years was -0.01 ± 0.35 D in the SMILE group and -0.23 ± 0.41 D in the FS-LASIK group. A regression of -0.02 ± 0.39 D in the SMILE group and -0.12 ± 0.32 D in the FS-LASIK group was observed between 6 months and 5 years postoperative time-points. TCRP increased by 0.39 ± 0.38 D in the SMILE group and 0.45 ± 0.49 D in the FS-LASIK group between 6-month and 5-year time-points. However, no statistically significant difference was found between the SMILE and FS-LASIK groups in terms of ∆SE, ∆CCT and ∆TCRP between 6 months and 5 years postoperative time-points.
Myopic regression was observed in terms of TCRP but not in subjective refraction. No statistically significant difference in stability was found between SMILE and FS-LASIK.
比较小切口微透镜取出术（SMILE）与飞秒激光 LASIK（FS-LASIK）的视力和像差结果。
本前瞻性、对照、非随机临床研究纳入 2011 年 12 月至 2013 年 1 月在复旦大学眼耳鼻喉科医院（中国上海）接受 SMILE 治疗的 37 例 38 眼患者和接受 FS-LASIK 治疗的 30 例 30 眼患者。术后随访 3、6 个月和 5 年。主要观察指标包括未矫正（UDVA）和矫正（CDVA）远视力、主观屈光度、中央角膜厚度（CCT）、总角膜屈光力（TCRP）和波前像差。
SMILE 组 50 只眼（98%）和 FS-LASIK 组 41 只眼（95%）术后 logMAR UDVA 为 0 或更好。SMILE 组术后 5 年等效球镜度（SE）为-0.01±0.35 D，FS-LASIK 组为-0.23±0.41 D。SMILE 组术后 6 个月至 5 年的 SE 呈-0.02±0.39 D 的回归，FS-LASIK 组呈-0.12±0.32 D 的回归。SMILE 组和 FS-LASIK 组术后 6 个月至 5 年时间点的 TCRP 分别增加 0.39±0.38 D 和 0.45±0.49 D。然而，SMILE 组和 FS-LASIK 组在术后 6 个月至 5 年的时间点上，SE、CCT 和 TCRP 的变化差异均无统计学意义。
在 TCRP 方面观察到近视回退，但在主观屈光度方面未观察到。SMILE 和 FS-LASIK 之间的稳定性差异无统计学意义。
