SMILE与改良去瓣Epi-LASIK矫正近视的疗效比较

摘要

目的:比较飞秒激光小切口角膜基质透镜取出术(SMILE)与改良去瓣机械法准分子激光原位角膜上皮瓣下磨镶术(Epi-LASIK)矫正近视术后1年的临床效果.方法:回顾性病例对照研究.选择2013年3月至2014年8月在南京总医院行SMILE的近视散光患者52例(103眼)作为SMILE组,行改良去瓣Epi-LASIK的近视散光患者43例(86眼)作为Epi-LASIK组.分别在术前,术后1d、1周、1个月、3个月、6个月、1年测量患者的裸眼视力(UCVA)、最佳矫正视力(BCVA)、残余散光、等效球镜度(SE),并于术后1年测量2组的对比敏感度(CS)、调制传递函数(MTF)、波前像差等.采用重复测量方差分析、t检验和卡方检验对数据进行分析.结果:术后1d及1周,SMILE组UCVA优于Epi-LASIK组,差异均有统计学意义(t=5.065、5.994,P＜ 0.001),余时间段2组间UCVA差异均无统计学意义.术后1年,2组间SE在±0.50 D和±1.00 D范围内的眼数百分比差异均无统计学意义,SMILE组柱镜度在±0.50 D范围内的眼数百分比高于Epi-LASIK组,差异有统计学意义(x2=10.734,P=0.001).术后1年,SMILE组在有眩光低空间频率(3、6cpd)的CS高于Epi-LASIK组,差异均有统计学意义(t=4.106、3.848,P＜ 0.001);2组在有眩光余空间频率和无眩光所有空间频率的CS差异均无统计学意义.在4 mm瞳孔直径下,2组间全眼像差、低阶像差、高阶像差、球差、慧差、三叶草像差及MTF值在各空间频率上的差异均无统计学意义.在6 mm瞳孔直径下,SMILE组的高阶像差、球差低于Epi-LASIK组,差异均有统计学意义(t=3.881、6.843,P＜0.001),2组间其他像差差异均无统计学意义;SMILE组在低空间频率和高空间频率(5、20、25、30 cpd)的MTF值均高于Epi-LASIK组,差异均有统计学意义(t=3.272,P=0.001;t=2.926,P=0.004;t=3.280,P=0.001;t=3.975,P＜0.001),其他空间频率差异均无统计学意义.结论:SMILE与改良去瓣Epi-LASIK矫正近视均安全、有效、稳定、预测性好,但SMILE对散光的矫正准确性更佳,且在6m m瞳孔直径下的视觉质量优于改良去瓣Epi-LASIK.%Objective:To compare one-year clinical outcomes between small incision lenticular extraction (SMILE) and off-flap epipolis laser in situ keratomileusis (Epi-LASIK) for myopia.Methods:In this retrospective case-control study,choosing from Nanjing General Hospital of PLA between March 2013 and August 2014,103 eyes of 52 patients underwent SMILE,and 86 eyes of 43 patients underwent off-flap Epi-LASIK.Uncorrected visual acuity (UCVA),best corrected visual acuity (BCVA),residual astigmatism,and spherical equivalent (SE) were evaluated preoperatively,at 1 day,1 week,at 1,3,and 6 months,and at 1 year postoperatively.Contrast sensitivity (CS),modulation transfer function (MTF),and wavefront aberrations were evaluated at 1 year postoperatively.Data were analyzed using repeated measures analysis of variance,independent-samples t-tests,and Chi-square tests.Results:At 1 day and 1 week after surgery,the UCVA for the SMILE group was significantly better than for the Epi-LASIK group (t=5.065,5.994,respectively,P＜0.001 for both);however for all other follow-up times,there were no significant differences in the UCVA between the two groups.At 1 year postoperatively,there was no significant difference in the frequency of eyes SE within ±0.5 diopter (D) or within ±1.0 D between the two groups respectively.However,the frequency with which the SMILE group attained a cylindrical refractive error within ±0.5 D was clearly higher than for the Epi-LASIK group (x2=10.734,P=0.001).The CS with glare at lowspatial frequency [3 and 6 cycles per degree (cpd)] in the SMILE group was significantly higher than for the Epi-LASIK group (t=4.106,3.848,P＜0.001).However,there were no significant differences in CS at other spatial frequencies,with or without glare between the two groups.Total order aberrations,lower-order aberrations,higher-order aberrations,spherical aberrations,coma,trefoil aberrations,and MTFs at all spatial frequencies with 4.0-mm pupils were not significantly different between the two groups.However with 6.0-mm pupils,higher-order aberrations and spherical aberrations of the SMILE group were significantly lower than in the Epi-LASIK group (t=3.881,6.843,P＜0.001 each).There were no significant differences in the other aberrations between the two groups.The MTFs were significantly higher in the SMILE group than in the Epi-LASIK group with 6-mm pupils at low and high spatial frequency (5,20,25,30 cpd) (t=3.272,P=0.001;t=2.926,P=0.004;t=3.280,P=0.001;t=3.975,P＜0.001 respectively).There were no significant differences in the MTFs at residual spatial frequency between the two groups.Conclusions:Both SMILE and off-flap Epi-LASIK are safe,efficient,stable,and predictable for the treatment of myopia.However,SMILE had better correction of astigmatic error,and with 6.0-mm pupils,SMILE had better visual quality than off-flap Epi-LASIK.