摘要背景 飞秒激光小切口角膜基质透镜取出术(SMILE)已广泛用于屈光不正的矫正,但是关于SMILE对不同程度屈光不正,尤其对不同程度近视及散光矫正后的早期临床效果评估研究较少. 目的 探讨和比较SMILE矫正低、中、高度近视的安全性、有效性、可预测性、早期稳定性及术眼角膜恢复特点.方法 采用系列病例观察研究方法.纳入2012年5-12月在天津市眼科医院拟行SMILE手术的近视患者108例195眼.根据临床近视分类标准将患眼分为低度近视组(≤-3.00 D)、中度近视组(＞-3.00 ～-6.00 D)和高度近视组(＞-6.00 D),其中低度近视组39例57眼,中度近视组38例76眼,高度近视组31例62眼,所有术眼均接受SMILE手术,分别于术前及术后1d、1周、1个月、3个月行裸眼视力(UCVA) (LogMAR)、最佳矫正视力(BCVA) (LogMAR)、屈光度、眼压、眼前节和角膜地形图检查,比较各组间术眼的有效性指数、安全性指数、等效球镜度(SE)、可预测性和稳定性. 结果 术后3个月时,低、中、高度近视组术眼UCVA(LogMAR) ＜0.1者分别占100％、97.1％和92.8％;所有术眼术后BCVA均达到术前BCVA;低、中、高度近视组术眼残余SE分别为(-0.07±0.16)、(-0.05±0.20)和(-0.08±0.27)D;低、中、高度近视组术眼的残余SE在±0.5D间者分别占100％、98.7％和93.6％,所有术眼残余SE均在±1.0D内.低、中、高度近视组术眼实际矫正SE均随着术前预计矫正SE的增加而增加(r=0.942、0.959、0.957,均P＜0.001). 结论 SMILE矫正低、中及高度近视均有较好的安全性、有效性、可预测性和早期稳定性.低度近视眼术后1周以内角膜创伤恢复时间较中度、高度近视眼略慢;少数高度近视眼在SMILE术后3个月表现出轻度屈光度回退,而中度近视眼SMILE矫正的安全性更好.

abstractsBackground Small incision lenticule extraction (SMILE) is increasingly applied in the correction of myopia and astigmatism.However,the early clinical outcomes of SMILE for different refractive myopia and astigmatism is seldom reported.Objective This study was to investigate the safety,efficacy,predictability and early stability after SMILE in low,moderate and high myopia.Methods A series of cases-observational study was carried out.A total of 195 eyes of 108 myopic patients were enrolled in Tianjin Eye Hospital from May to December 2012 under the informed consent.The patients were divided into the low (≤-3.00 D),moderate (＞-3.00 to-6.00 D) and high myopia (＞-6.00 D) groups according to different diopters,with 57 eyes,76 eyes and 62 eyes,respectively.SMILE was performed on all the eyes.The uncorrected visual acuity (UCVA)(LogMAR),best corrected visual acuity (BCVA) (LogMAR),equivalent sphere (SE),intraocular pressure,anterior segment and corneal topography were examined before operation and 1 day,1 week,1 month and 3 months after operation to evaluate the effective index (postoperative UCVA/preoperative BCVA),safety index (postoperative BCVA/preoperative BCVA),predictability and early stability of SMILE.The linear regression analysis was used to analyze the relationships between the attempted refraction and the achieved refraction postoperative 3 months in three groups.Results The percentage of UCVA (LogMAR)＜0.1 was 100％,97.1％ and 92.8％ in the low,moderate and high myopia group,respectively in 3 months after SMILE.The postoperative BCVA of all the operated eyes reached preoperative one.The residual SE was (-0.07±0.16),(-0.05 ±0.20) and (-0.08±0.27)D in the low,moderate and high myopia group,respectively in 3 months after SMILE.The percentage of residual SE±0.5 D was 100％,98.7％ and 93.6％ in the low,moderate and high group,and that of SE±1.0 D was 100％ in all of the groups.The postoperative corrected SE was gradually increased with the raise of predicted SE in the low,moderate and high myopia groups (r=0.942,0.959,0.957,all at P＜0.001).Conclusions SMILE is safe,effective,predictable and stable for the correction of low,moderate and high myopia.The corneal wound healing was slightly slower in the low myopia group than that in the moderate and high group.A slight regression of myopic power appears in high myopia eyes 3 months after SMILE.