摘要：Background Researches showed that femtosecond laser corneal small incision lenticule extraction (SMILE) was used in the correction of myopia and myopic astigmatism due to its fast recovery,good shortterm efficacy and few complications.However,few research focused on its long-term efficacy.Objective Thisstudy was to evaluate the effectiveness,safety,predictability,stability and complications of SMILE.Methods A serial cases-observational study was carried out under the approval of Ethic Committee of Henan Eye Institute and informed consent of patients.Sixty-seven eyes of 34 patients with myopia and myopic astigmatism were included in Henan Eye Institute from January to June 2013.All the patients received SMILE and followed-up for 2-year duration.The uncorrected visual acuity (UCVA),best corrected visual acuity (BCVA),automatic optometry,intraocular pressure and corneal topography were examined before surgery and 1 day,1 week,1 month,3 months,1 year and 2 years after surgery and calculated the spherical equivalent (SE).The long-term efficacy of SMILE included effective index (preoperative BCVA/postoperative UCVA),safety index (postoperative BCVA/ preoperative BCVA),predictability (linear regression analysis between actual SE and attempted SE) and refractive stability (SE changes at postoperative time points).Results The preoperative BCVA was ≥ 20/20 in 60 eyes with the percentage of 89.55％.UCVA≥ 20/20 were found in 61 eyes and 60 eyes in postoperative 3 months and 2 years respectively (91.04％ and 89.55％).The effective index was 1.038±0.182 and 1.029±0.231 in postoperative 3 months and 2 years respectively,showing an insignificant difference between them (t =0.400,P ＞ 0.05).Compared with the preoperative BCVA,8.96％ (6/67) and 10.45％ (7/67) eyes lost 1 line at 3 months and 2 years after surgery,respectively.The safety indexes were 1.141±0.193 and 1.312±0.242 at 3 months and 2 years after surgery,with no significant difference between them (t =0.414,P＞0.05).A linear correlation was found between actual SE and attempted SE both at postoperative 3 months and 2 years,with the linear regression equations of Y=0.897 1X-0.440 8 (R2 =0.914 2,P＜0.05) and Y =0.893 7X-0.382 3 (R2 =0.915 7,P＜0.05),respectively.The SE was (0.013±0.578),(-0.033±0.489),(-0.106±0.508),(-0.103±0.375),(-0.154±0.518) and (-0.147±0.366)D 1 day,1 week,1 month,3 months,1 year and 2 years after surgery,respectively,and there were no significant difference among different time points (F =0.185,P =0.176).Eighteen in the 67 eyes occurred opaque bubble layer after surgery.Diffuse lamellar keratitis appeared in 6 eyes and punctate keratitis was in 2 eyes.These complications were cured 1 month after administration of drugs.Conclusions SMILE is good in effectiveness,safety,predictability and refreactive stability and has fewer complications during 2-year following-up.%背景 已有研究表明飞秒激光小切口基质透镜取出术(SMILE)短期疗效好,术后视力恢复快,并发症少,因此已广泛用于临床,但目前仍缺乏其术后长期疗效和安全性评价研究. 目的 评估SMILE矫正近视及近视散光的远期有效性、安全性、可预测性、稳定性及相关手术并发症. 方法 采用系列病例观察研究方法,纳入2013年1-6月在河南省眼科研究所就诊的近视及近视散光患者34例67眼,所有患者均由同一有角膜屈光手术经验的医师行SMILE,分别于术前,术后1d、1周、1个月、3个月、1年及2年时进行随访观察,检查患者裸眼视力(UCVA)、最佳矫正视力(BCVA)、电脑验光、主觉验光、眼压及角膜地形图等参数.SMILE的效果评价指标主要包括有效性指数(术前BCVA/术后UCVA值)、安全性指数(术后BCVA/术前BCVA值)、可预测性[对术眼实际等效球镜度(SE)与预矫正SE进行线性回归分析]和术后屈光稳定性(术后不同时间点SE变化). 结果 术前术眼BCVA≥20/20者60眼,占89.55％;术后3个月及2年分别有61眼和60眼UCVA≥20/20,分别占91.04％和89.55％.术后3个月和2年时SMILE有效性指数分别为1.038±0.182和1.029±0.231,差异无统计学意义(t=0.400,P＞0.05).与术前BCVA相比,术后3个月及2年分别有8.96％和10.45％术眼BCVA降低1行,未发现BCVA降低2行及以上者;术后3个月和2年SMILE安全性指数分别为1.141±0.193和1.312±0.242,差异有统计学意义(t=0.414,P＞0.05).术后3个月及2年术眼实际SE与预矫正SE均呈明显线性关系,回归方程分别为Y=0.897 1X-0.440 8(R2 =0.914 2,P＜0.05)和y=0.893 7X-0.382 3(R2=0.915 7,P＜0.05).术后1d、1周、1个月、3个月、1年和2年术眼SE分别为(0.013±0.578)、(-0.033±0.489)、(-0.106±0.508)、(-0.103±0.375)、(-0.154±0.518)和(-0.147±0.366)D,总体比较差异无统计学意义(F=0.185,P=0.176).术中12例18眼出现轻度弥散型不透明气泡(OBL),4例6眼发生弥漫性板层角膜炎(DLK),1例2眼出现点状角膜炎,药物治疗后症状消失. 结论 SMILE治疗近视及近视散光并发症少,术后2年随访证实其有效性、安全性、可预测性和稳定性较好.