方法：回顾性研究。纳入2019-07/12行SMILE手术的近视及近视合并散光患者85例85眼，术后随访1a，观察裸眼远视力(UDVA)、矫正远视力(CDVA)、等效球镜度(SE)等情况，评估手术的有效性、安全性及可预测性，并测量全角膜高阶像差及客观视觉质量。

结果：术后1a，本组患者SMILE手术有效性指数1.08，其中84眼UDVA(99%)达到或高于术前CDVA，22眼(26%)UDVA高于术前CDVA 1行； 手术安全性指数1.04，其中59眼(69%)CDVA与术前CDVA一致，24眼(28%)CDVA较术前CDVA增加1行，2眼(2%)CDVA较术前CDVA增加2行； 85眼(100%)等效球镜度均在±0.50D范围内； 术前预期矫正SE与术后实际矫正SE呈高度线性相关(Y=0.9949X-0.0033； R²=0.9977)； 本组患者6mm瞳孔直径下全角膜总高阶像差(HOA)、球差、彗差均较术前增加(P<0.001)； 调制传递函数截止频率(MTF_cutoff)和斯特列尔比(SR)均高于术前(P<0.05)。

结论：SMILE手术治疗近视安全、有效、稳定、预测性良好，矫正中低度散光准确性好，术后视网膜成像质量优于术前。

METHODS: Retrospective comparative analysis of 85 patients(85 eyes)were treated with SMILE between July and December 2019. Pre- and postoperative uncorrected distance visual acuity(UDVA), corrected distance visual acuity(CDVA), spherical equivalent refraction(SE)were all observed, to evaluate the efficacy, safety and predictability after SMILE refractive surgery. Total corneal higher-order aberrations(HOAs), modulation transfer function cut-off(MTF_cutoff), strehl ratio(SR), and objective scattering index(OSI)were evaluated.

RESULTS: One year after SMILE refractive surgery, the efficacy index was 1.08, 84 eyes(99%)reached an UDVA as or over CDVA preoperatively, 22 eyes(26%)gained one line of CDVA than preoperatively. The safety index was 1.04, 59 eyes(69%)of the treated eyes had an unchanged CDVA postoperatively, 24 eyes(28%)gained one line of CDVA, 2 eyes(2%)gained two lines of CDVA. 85 eyes(100%)were all within ±0.50D. The pre-correction is highly related with the actual correction of SE(Y=0.9949X-0.0033; R²=0.9977). HOA, spherical aberration and coma were increased under pupil diameters of 6mm(all P<0.001). Both MTF_cutoff and SR were higher than that of SMILE preoperatively(P<0.05).

CONCLUSION: SMILE demonstrated to be safe, effective, and predictable in the treatment of myopia and myopic astigmatism, and good accuracy in correcting medium and low astigmatism. The post-quality of retinal image is better than that of SMILE preoperatively.