方法：前瞻性非随机临床研究。收集符合研究标准的600眼接受全面眼科检查，包括矫正远视力、对比敏感度、像差和干眼的评估。SMILE采用VisuMax全飞秒激光系统。术后1，15d及3mo对患者进行随访，并记录术前和术后3mo内的裸眼视力、矫正远视力、像差、干眼和对比敏感度。数据分析采用SPSS(美国，版本17.0)软件。计量资料采用配对t检验统计，计数资料采用Yate卡方检验统计。P<0.05则差异有统计学意义。

结果：本研究包含305例(600眼)患者。其中，10位患者由于屈光参差仅单眼接受SMILE。术后3mo，98.83%眼裸眼视力达到或超过20/20。所有患者矫正远视力无下降并且有37眼(6.17%)提高了一行。术后产生的彗差和球面像差最小。术后早期对比敏感度减少(P<0.01)，但3mo后增加，特别是低频尤为明显(P=0.43、0.47、0.46)。

结论：结果表明，ReLEx^®SMILE治疗近视和近视散光精确安全，与其他屈光手术一样，术后干眼和像差有所增加，但低频对比敏感度的下降不明显。

METHODS: In this prospective, non-randomized clinical study, done at Nethradhama Super Speciality Eye Hospital, a total of 600 eyes that met the inclusion criteria underwent a thorough preoperative examination, including corrected distance visual acuity(CDVA), contrast sensitivity, aberrometry, and dry eye assessment. VisuMax femtosecond laser system was used to perform SMILE. Patients were followed up on 1, 15d and 3mo. Pre and postoperative uncorrected visual acuity(UCVA), CDVA, aberrations, dry eye, and contrast sensitivity during 3mo of follow-up were recorded. Data analysis was done with the help of a computer using SPSS for Windows Software(version 17.0, SPSS, Inc., New York, USA). A paired t-test was used to test the significance of difference between quantitative variables and Yate's Chi-square test for qualitative variables. P value less than 0.05 denoted a significant relationship.

RESULTS: The study enrolled 600 eyes of 305 patients, of which 10 patients underwent SMILE in 1 eye only due to anisometropia. At 3mo, 98.83% of eyes had attained a UCVA of 20/20 or better. No patient had a loss of CDVA, and 37 eyes(6.17%)showed a gain in 1 line in postoperative CDVA. Postoperative induction of coma and spherical aberrations was minimal. Contrast sensitivity reduced immediate postoperatively(P<0.001)but showed improvement by 3mo, especially at lower spatial frequencies(P=0.43, 0.47, 0.46)

CONCLUSION:Our results demonstrate the high refractive accuracy and safety of ReLEx^® SMILE for the treatment of myopia and myopic astigmatism. Increase in postoperative dryness and aberrations, both accepted drawbacks of any corneal refractive surgery were observed, while decrease in contrast sensitivity was insignificant at lower spatial frequencies.