SMILE矫正近视术后一年临床疗效

A Small Incision Lenticule Extraction Procedure for the Correction of Myopia after One Year

目的:观察飞秒激光小切口角膜基质透镜取出术(SMILE)矫正低、中、高度近视术后1年的临床疗效。方法:回顾性系列病例研究。收集2014年12月至2015年9月于中国人民解放军武汉总医院眼科行SMILE并完成1年随访的近视患者86例(141眼)病历资料,按照术前等效球镜度(SE)分为3组:低度近视组:-0.50D<SE≤-3.00D,35眼;中度近视组:-3.00D<SE≤-6.00D,54眼;高度近视组:-6.00D<SE≤-10.00D,52眼。分析患者术前,术后1个月、3个月、6个月和1年的裸眼视力(UCVA)、最佳矫正视力(BCVA)和SE情况。采用重复测量方差分析和单因素方差分析进行统计分析。结果:术后各组UCVA随时间点的变化均逐渐提高(P<0.001)。术后1年,3组UCVA≥5.0的眼数分别为35(100%)、54(100%)、50(96%);3组有效指数(EI)分别为1.00±0.01、1.00±0.01、0.99±0.02;3组BCVA均较术前提高,低、中度近视组术后与术前比较差异均有统计学意义(F=4.73,P<0.001;F=19.53,P<0.001),高度近视组术后与术前比较差异无统计学意义;3组均无BCVA较术前下降2行及以上者,BCVA达到术前或更好者分别为:34(97%)、51(94%)、47(90%);3组安全性指数(SI)分别为1.01±0.01、1.01±0.01、1.00±0.01。术后1年内低度近视组SE保持稳定;中度近视组术后早期SE略偏正,后逐渐趋于0,并保持稳定;高度近视组术后早期为正视,到术后1年略偏负。结论:低、中、高度近视患者SMILE术后均获得了良好的视力,良好的有效性、安全性、可预测性和稳定性,其中低、中度近视效果更佳。

Objective:To evaluate the clinical effect after a femtosecond laser corneal small incision lenticule extraction(SMILE)procedure for the correction of low,moderate,and high myopia.Methods:This was a retrospective case series study.86 patients(141 eyes)with myopia were chosen to undergo the SMILE procedure between December 2014 and September 2015 at the Department of Ophthalmology,Wuhan General Hospital of the Chinese PLA,all patients completed 1 year of follow-up.The average age of the patients was 23.9±5.2 years(range 18 to 35 years).According to the preoperative spherical equivalent(SE),treated eyes were divided into three groups:a low myopia group(-0.50 D<SE≤-3.00 D)with 35 eyes,a moderate myopia group(-3.00 D<SE≤-6.00 D)with 54 eyes,and a high myopia group(-6.00 D<SE≤-10.00 D)with 52 eyes.Preoperative SE was-2.12±0.63 D,-4.71±0.88 D,and-7.24±0.76 D in the three groups,respectively.Follow-up visits were at 1 day,1 week and 1,3,6,12 months after surgery.The outcome measures included uncorrected visual acuity(UCVA),best corrected visual acuity(BCVA)and postoperative SE.The results were analyzed with repeated measures analysis of variance and single factor analysis.Results:UCVA gradually increased with time after surgery in all three groups(P<0.001).At one year postoperatively,35 eyes(100%),54 eyes(100%)and 50 eyes(96%)had a UCVA of 5.0 or greater in the three respective groups.The efficacy indexes were 1.00±0.01,1.00±0.01,0.99±0.02 for the three groups.BCVA gradually increased after SMILE in the low and moderate myopia groups(F=4.73,P<0.001;F=19.53,P<0.001),but there was no significant difference in the high myopia group(F=1.87,P=0.12).No eyes lost two or more lines.Thirty-four eyes achieved a stable or improved BCVA postoperatively included 34(97%),51(94%),47(90%)in the low,moderate and high myopia groups,respectively.The safety indexes were 1.01±0.01,1.01±0.01,1.00±0.01 for the three groups.The postoperative SE in the low myopia group remained stable,while in the moderate myopia group,it was overcorrected in the early stages after surgery and gradually reached emmetropia at one year.In the high myopia group,there was a little regression at one year.Conclusions:All patients achieved good vision after SMILE,and SMILE is a safe and effective procedure for the correction of low,moderate,and high myopia,and has excellent predictability and stability,especially for low and moderate myopia.