目的：比较飞秒激光微切口角膜基质透镜摘除术(femtosecond laser micro-incision corneal stroma lens removal，SMILE)与准分子激光原位角膜磨镶术(excimer laser in situ wear for cornea， LASIK)治疗近视的术后疗效，探讨SMILE的安全性、可操作性和预测性。

方法：前瞻性临床对照研究。随机选取我院同时期行SMILE患者100例200眼和行LASIK患者100例200眼。比较两组1d； 1wk； 1，3，6mo； 1a术后裸眼视力、屈光度、矫正视力、裂隙灯角膜的检查、眼压及前节OCT、角膜地形图(ObscanⅡ)。采用独立样本t检验进行数据分析。

结果：(1)术后裂隙灯检查：术后1d，SMILE组少部分术眼有轻度角膜层间混浊或水肿； 术后1wk，SMILE组角膜层间的混浊水肿均消失，角膜恢复清亮透明。(2)术后视力恢复：术后1d，LASIK组视力恢复优于SMILE组，差异有显著统计学意义(P<0.01)，术后1wk； 1，3，6mo； 1a差异均无统计学意义(P>0.05)。(3)ObscanⅡ检查：术后随访中，SMILE组角膜前表面图形更加规则和居中，无偏心和不规则图形，优于LASIK组。(4)眼前节OCT的检查：SMILE组术后角膜瓣更加均匀和精准； 而LASIK组角膜瓣中间薄，中周部略厚。(5)术后视觉质量评估采用主观问卷调查。两组4分和1分差异有统计学意义(P<0.05)，LASIK组抱怨者多于SMILE组，而完全没有抱怨者SMILE组多于LASIK组。术后患者夜视力和暗环境下的眩光情况，SMILE组明显优于LASIK组。

结论：SMILE对于矫正近视安全、有效、稳定、可预测性好。

AIM: To analyze and compare the effect of femtosecond laser micro-incision corneal stromal lens excision(SMILE)and excimer laser in situ keratomileusis(LASIK)in the treatment of myopia after operation, to explore the safety, operability and prediction of SMILE.

METHODS: In this prospective clinical controlled study, 100 cases(200 eyes)received SMILE and 100 cases(200 eyes)undergone LASI in our hospital in the same period were selected. Uncorrected visual acuity, diopter, corrected visual acuity, slit lamp examination, intraocular pressure and corneal anterior segment OCT, corneal topography(Obscan II)of two groups in 1d, 1wk, 1, 3, 6mo, 1a were compared. Independent samples t test was used for data analysis.

RESULTS: 1)Postoperative slit lamp examination: after 1d in SMILE group, there were less eyes had corneal layer between mild cloudy or edema; postoperative 1wk corneal layer disappeared, cornea became clear and transparent. 2)Postoperative vision recovery: 1d after operation, vision recovery in LASIK group was better than that in SMILE group, the difference was statistically significant(P<0.01), there were no significant differences at 1wk, 1, 3, 6mo, 1a after operation(P>0.05). 3)Obscan II examination: graphics in the SMILE group was more regular and placed in the center, no eccentric and irregular graphics, better than that in the LASIK group. 4)Anterior segment OCT examination: postoperative corneal flap in the SMILE group was more uniform and accurate, but it was thin in the center and slightly thick the peripheral part in the LASIK groups. 5)Postoperative visual quality assessment used subjective questionnaire survey. The two groups had statistically significant difference on 4 points and 1 points(P<0.05). Complains in the LASIK groups were more that that in the SMILE group. While, no complain of the SMILE group was higher than that of the LASIK group. Glare of postoperative patients with night vision and dark environment in the SMILE group was better than that of the LASIK group.

CONCLUSION: SMILE is safe, effective, stable and predictable for the correction of myopia.