方法：前瞻性临床对照研究。近视及近视散光患者547例1 080眼，按患者选择的手术方式分为两组，小切口角膜基质透镜取出术(small incision lenticule extraction，SMILE)组285例560眼，飞秒激光辅助的准分子激光原位角膜磨镶术(femtosecond laser assisted laser in situ keratomileusis，FS-LASIK)组262例520眼。术后随访12mo，分别于术后第1d，1wk，1、6、12mo复查，检查裸眼及矫正视力、屈光度、裂隙灯及角膜地形图，并测量偏中心切削值。

结果：术后第1d，1wk，1、6、12mo，SMILE组的裸眼视力(uncorrected visual acuity，UCVA，以LogMAR视力表示)分别为0.029±0.13、0.001±0.11、-0.019±0.11、-0.020±0.08、-0.011±0.10； FS-LASIK组分别为-0.017±0.08、-0.019±0.09、-0.031±0.10、-0.024±0.09、-0.002±0.12； 术后1d和1wk，SMILE组视力低于FS-LASIK组，两组比较差异有统计学意义(P<0.05)，其它时间点差异无统计学意义(P>0.05)。术后1、6、12mo，SMILE组的等效球镜(spherical equivalent，SE)分别为-0.03±0.29、-0.04±0.28、-0.06±0.32D； FS-LASIK组分别为0.02±0.20、-0.01±0.29、-0.08±0.33D，两组比较术后1mo的结果差异有统计学意义(P<0.05)，其余时间点两组的差异无统计学意义(P>0.05)。术后3mo，SMILE组测量的偏中心切削值为0.21±0.11mm，FS-LASIK组为0.20±0.08mm，两组比较差异无统计学意义(P>0.05)。

结论：SMILE治疗近视及近视散光有良好的有效性、可预测性、稳定性和安全性，但与FS-LASIK比较，术后早期视力恢复慢。

METHODS: This was a prospective clinical controlled study involved 547 patients(1080 eyes)with myopia and astigmatism. Out of these, 560 eyes of 285 patients were treated with SMILE and 520 eyes of 262 patients were treated with femtosecond laser assisted laser in situ keratomileusis(FS-LASIK). The patients were followed up 12mo after operation and received ophthalmologic examinations including uncorrected visual acuity(UCVA), best corrected visual acuity(BCVA), manifest refraction, slitlamp examination and corneal topography at 1d,1wk and 1,6 and 12mo. The value of decentration from pupil center was measured at 3mo.

RESULTS: The UCVA at 1d, 1wk, 1, 6 and 12mo were respectively 0.029±0.13 LogMAR, 0.001±0.11LogMAR,-0.019±0.11 LogMAR, -0.020±0.08 LogMAR, -0.011±0.10 LogMAR in SMILE group, and -0.017±0.08 LogMAR, -0.019±0.09 LogMAR, -0.031±0.10 LogMAR, -0.024±0.09 LogMAR, -0.002±0.12 LogMAR in FS-LASIK group. The UCVA in SMILE group were significantly lower than that in FS-LASIK group at 1d and 1wk(P<0.05), while no difference were observed at other time points. The spherical equivalent(SE)at 1,6 and 12mo were respectively -0.03±0.29D, -0.04±0.28D,-0.06±0.32D in SMILE group, and 0.02±0.20D,-0.01±0.29D,-0.08±0.33D in FS-LASIK group, and the difference was statistically significant at 1mo(P<0.05), except other time points. At 3mo, the mean decentration from pupil center were 0.21±0.11mm for SMILE group and 0.20±0.08mm for FS-LASIK group, there was no significant difference between the two groups(P>0.05).

CONCLUSION: SMILE is effective, predictable, stable and safe for myopia and astigmatism. However, SMILE showed slower vision recovery compared with FS-LASIK in the early postoperative period.