Shen Zeren, Shi Keda, Yu Yinhui, Yu Xiaoning, Lin Yuchen, Yao Ke
Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Department of Gastroenterology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
PLoS One. 2016 Jul 1;11(7):e0158176. doi: 10.1371/journal.pone.0158176. eCollection 2016.
The goal of this study was to compare small incision lenticule extraction (SMILE) with femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for treating myopia.
The CENTRAL, EMBASE, PubMed databases and a Chinese database (SinoMed) were searched in May of 2016. Twelve studies with 1,076 eyes, which included three randomized controlled trials (RCTs) and nine cohorts, met our inclusion criteria. The overall quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group framework. Data were extracted and analysed at three to six months postoperatively. Primary outcome measures included a loss of one or more lines of best spectacle corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA) of 20/20 or better, mean logMAR UCVA, postoperative mean spherical equivalent (SE) and postoperative refraction within ±1.0 D of the target refraction. Secondary outcome measures included ocular surface disease index (OSDI), tear breakup time (TBUT) and Schirmer's 1 test (S1T) as dry eye parameters, along with corneal sensitivity.
The overall quality of evidence was considered to be low to very low. Pooled results revealed no significant differences between the two groups with regard to a loss of one or more lines in the BSCVA (OR 1.71; 95% CI: 0.81, 3.63; P = 0.16), UCVA of 20/20 or better (OR 0.71; 95% CI: 0.44, 1.15; P = 0.16), logMAR UCVA (MD 0.00; 95% CI: -0.03, 0.04; P = 0.87), postoperative refractive SE (MD -0.00; 95% CI: -0.05, 0.05; P = 0.97) or postoperative refraction within ±1.0 D of the target refraction (OR 0.78; 95% CI: 0.22, 2.77; P = 0.70) within six months postoperatively. The pooled analysis also indicated that the FS-LASIK group suffered more severely from dry eye symptoms (OSDI; MD -6.68; 95% CI: -11.76, -2.00; P = 0.006) and lower corneal sensitivity (MD 12.40; 95% CI: 10.23, 14.56; P < 0.00001) at six months postoperatively.
In conclusion, both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK.
本研究的目的是比较小切口基质透镜切除术（SMILE）与飞秒激光原位角膜磨镶术（FS-LASIK）治疗近视的效果。
于2016年5月检索CENTRAL、EMBASE、PubMed数据库以及一个中文数据库（中国生物医学文献数据库）。12项研究共涉及1076只眼，其中包括3项随机对照试验（RCT）和9个队列研究，符合我们的纳入标准。使用推荐分级的评估、制定与评价（GRADE）工作组框架对证据的总体质量进行评估。在术后三至六个月提取并分析数据。主要结局指标包括最佳矫正视力（BSCVA）下降一行或多行、裸眼视力（UCVA）达到20/20或更好、平均logMAR UCVA、术后平均球镜等效度（SE）以及术后屈光度在目标屈光度±1.0 D范围内。次要结局指标包括眼表疾病指数（OSDI）、泪膜破裂时间（TBUT）和Schirmer试验1（S1T）作为干眼参数，以及角膜敏感性。
证据的总体质量被认为是低至极低。汇总结果显示，两组在术后六个月内，BSCVA下降一行或多行（比值比[OR]1.71；95%置信区间[CI]：0.81，3.63；P = 0.16）、UCVA达到20/20或更好（OR 0.71；95% CI：0.44，1.15；P = 0.16）、logMAR UCVA（平均差[MD]0.00；95% CI：-0.03，0.04；P = 0.87）、术后屈光SE（MD -0.00；95% CI：-0.05，0.05；P = 0.97）或术后屈光度在目标屈光度±1.0 D范围内（OR 0.78；95% CI：0.22，2.77；P = 0.70）方面无显著差异。汇总分析还表明，FS-LASIK组在术后六个月干眼症状更严重（OSDI；MD -6.68；95% CI：-11.76，-2.00；P = 0.006），角膜敏感性更低（MD 12.40；95% CI：10.23，14.56；P < 0.00001）。
总之，FS-LASIK和SMILE都是治疗近视安全、有效且可预测的手术选择。然而，SMILE术后干眼症状和角膜敏感性丧失可能比FS-LASIK术后更少见。
