摘要
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跟和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=0．8971X-0．4408（R^2=0．9142，P〈0．05）和Y=0．8937X-0．3823（R^2=0．9157，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。
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 short-term efficacy and few complications. However, few research focused on its long-term efficacy. Objective This study was to evaluate the effectiveness, safety, predictability, stability and complications of SMILE. Methods A serial cases-observational studv 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 Heuan 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- 0.4408 （R^2=0.9142,P〈0.05） and Y= 0. 893 7X-0. 382 3 （R^2=0.9157,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.
出处
《中华实验眼科杂志》
CAS
CSCD
北大核心
2016年第9期818-822,共5页
Chinese Journal Of Experimental Ophthalmology
关键词
角膜基质/手术
激光疗法
治疗效果
近视/手术
散光/手术
飞秒激光
基质透镜取出术
小切口
人
Corneal stroma/surgery
Laser therapy
Treatment outcome
Myopia/surgery
Astigmatism/ surgery
Femtoseeond laser
Corneal lenticule extraction
Small incision
Human
