Wang Jia-Song, Xie Hua-Tao, Jia Ye, Zhang Ming-Chang
Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Int J Ophthalmol. 2017 Jan 18;10(1):115-121. doi: 10.18240/ijo.2017.01.19. eCollection 2017.
To examine differences in efficacy, accuracy, safety, aberrations and corneal biomechanical between Small incision lenticule extraction (SMILE) and femtosecond lenticule extraction (FLEx) for myopia.
Comprehensive studies were conducted on the PubMed, MEDLINE, EMBASE, and Cochrane Controlled Trials Register before 31 July, 2015. Meta-analyses were performed on the primary outcomes [loss of ≥2 lines of corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA) ≥20/20, spherical equivalent (SE) within ±0.50 diopters (D), final refractive SE], secondary outcomes were high-order aberrations (HOAs) and corneal biomechanical [central corneal thickness (CCT), corneal hysteresis (CH) and corneal resistance factor (CRF)].
Seven trials describing a total of 320 eyes with myopia were included in this Meta-analysis. No significant differences were found in the efficacy [UDVA weighted mean difference (WMD) -0.01; 95%CI: -0.04 to 0.01; =0.37, UDVA ≥20/20, OR 1.49; 95%CI: 0.78 to 2.86; =0.23], accuracy (SE WMD -0.03; 95%CI: -0.12 to 0.07; =0.58, SE within ±0.5 D OR 1.25; 95%CI: 0.34 to 4.65; =0.74), HOAs (WMD -0.04; 95%CI: -0.09 to 0.01; =0.14) and CCT WMD 1.83; 95%CI: -7.07 to 10.72; =0.69, CH WMD -0.01; 95%CI: -0.42 to 0.40; =0.97, CRF WMD 0.17; 95%CI: -0.33 to 0.67; =0.50) in the last fellow-up. But for safety, FLEx may achieve fewer CDVA lost two or more two lines (OR 11.11; 95%CI: 1.27 to 96.86; =0.03) than SMILE, however CDVA (WMD 0.00; 95%CI: -0.03 to 0.02; =0.77) is similar.
SMILE and FLEx are comparable in terms of both efficacy, accuracy, aberrations and corneal biomechanical measures in the follow-up, but FLEx seems to be better in safety measures. The results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed.
探讨小切口基质透镜切除术（SMILE）与飞秒激光基质透镜切除术（FLEx）治疗近视在疗效、准确性、安全性、像差及角膜生物力学方面的差异。
于2015年7月31日前在PubMed、MEDLINE、EMBASE和Cochrane对照试验注册库进行全面检索。对主要结局指标[矫正远视力（CDVA）下降≥2行、未矫正远视力（UDVA）≥20/20、等效球镜度（SE）在±0.50屈光度（D）范围内、最终屈光SE]进行荟萃分析，次要结局指标为高阶像差（HOAs）和角膜生物力学指标[中央角膜厚度（CCT）、角膜滞后（CH）和角膜阻力因子（CRF）]。
本荟萃分析纳入了7项共320只近视眼的试验。末次随访时，在疗效[UDVA加权均数差（WMD）-0.01；95%CI：-0.04至0.01；P = 0.37，UDVA≥20/20，OR 1.49；95%CI：0.78至2.86；P = 0.23]、准确性（SE WMD -0.03；95%CI：-0.12至0.07；P = 0.58，SE在±0.5 D范围内OR 1.25；95%CI：0.34至4.65；P = 0.74）、HOAs（WMD -0.04；95%CI：-0.09至0.01；P = 0.14）以及CCT WMD 1.83；95%CI：-7.07至10.72；P = 0.69，CH WMD -0.01；95%CI：-0.42至0.40；P = 0.97，CRF WMD 0.17；95%CI：-0.33至0.67；P = 0.50]方面未发现显著差异。但在安全性方面，FLEx可能比SMILE导致CDVA下降两行或更多行的情况更少（OR 11.11；95%CI：1.27至96.86；P = 0.03），不过CDVA（WMD 0.00；95%CI：-0.03至0.02；P = 0.77）相似。
SMILE和FLEx在随访中的疗效、准确性、像差及角膜生物力学指标方面具有可比性，但FLEx在安全性方面似乎更好。尽管相关证据仍在积累，但由于证据有限，对结果的解释应谨慎。迫切需要进一步开展大规模、设计良好的随机对照试验。
