方法：选取超高度近视患者64例 128眼，随机分为SMILE组与FS-LASIK组各32例 64 眼，分别给予VisuMax飞秒激光系统下SMILE治疗和飞秒激光制瓣的LASIK(femtosecond laser LASIK，FS-LASIK)，观察术前，术后1d，1wk，1、3、6mo裸眼视力、最佳矫正视力、等效球镜，计算有效性指数及安全性指数等。

结果：安全性指数：SMILE组与FS-LASIK组术后6mo时分别为1.10±0.10和1.08±0.12，两组相比差异无统计学意义(P>0.05)。有效性指数：SMILE组与FS-LASIK组术后6mo时分别为1.08±0.12和1.06±0.14，两组相比差异无统计学意义(P>0.05)。术后6mo时的等效球镜SMILE组为0.09±0.36D，FS-LASIK组为0.36±0.46D，两组患者等效球镜在±0.50D 者SMILE组有58眼(90.1%)，FS-LASIK组有49 眼(76.6%)； 在±1.0D 者SMILE组有64 眼(100%)， FS-LASIK组有60眼(93.8%)。

结论：采用SMILE 治疗超高度近视安全有效，与FS-LASIK相比SMILE术后视力和屈光度能更早稳定下来。

METHODS: Totally 64 cases(128 eyes)patients with super high myopia, were randomly divided into observation group and control group, 32 cases(64 eyes)in each group. The two groups were separately treated with SMILE or femtosecond laser LASIK(FS-LASIK). We calculated the effectiveness index and safety index by contrastive observation of clinical effects in all patients included uncorrected visual acuity, best corrected visual acuity and postoperative spherical equivalent at preoperative and postoperative 1d, 1wk, 1, 3 and 6mo.

RESULTS: The safety index: the observation group and the control group at 6mo after operation were respectively 1.10±0.10 and 1.08±0.12, the difference between the two groups was not statistically significant(P>0.05). The validity index: the observation group and the control group at 6mo after operation were respectively 1.08±0.12 and 1.06±0.14 and there was no significant difference between the two groups(P>0.05). Postoperative spherical equivalent at 6mo in the observation group was 0.09±0.36D, that in the control group was 0.36±0.46D. After 6mo, the count of spherical equivalent refraction within ±0.50D were 58 eyes(90.1%)in observation group and 49 eyes(76.6%)in the control group, within±1.0D were 64 eyes(100%)and 60 eyes(93.8%).

CONCLUSION: SMILE is safe and effective in the treatment for super high myopia. The postoperative visual acuity and diopter can be stabilized earlier by comparing with FS-LASIK.