有晶状体眼后房型人工晶状体植入术与角膜屈光手术治疗高度近视眼有效性、安全性及可预测性的Meta分析

The efficacy,safety and predictability of the implantable collamer lens and corneal refractive surgery for high myopia:Meta-analysis

目的系统评价有晶状体眼后房型人工晶状体植入术(ICL)与角膜屈光手术(CRS)治疗高度近视眼的有效性、安全性及可预测性。方法检索Pubmed、Embase、Cochrane Library、中国知网及万方数据库等数据库,检索日期为自建库之始至2020年5月,搜集ICL与CRS治疗高度近视眼的观察性研究与随机对照试验。由两位研究员独立筛选文献并提取平均等效球镜、等效球镜范围、ICL手术类型、CRS手术类型及屈光不正类型等结局指标。文献研究间的异质性采用I_(2)检验。若I_(2)>50%,采用随机效应模型进行比较,否则采用固定效应模型。二分类变量采用相对风险度(RR)及其95%可信区间(CI)表示。结果初步检索获得相关文献476篇,排除重复、与本研究无关及不符合本研究结局指标的文献,最终纳入文献11篇,共计988只眼。11篇文献均为观察性研究。所有受试者均为高度近视眼或高度近视眼伴散光的成年人(18岁或以上)。ICL组和CRS组患者的术前等效球镜屈光度范围分别为-6.00 D~-25.75 D和-6.00 D~-23.75 D。纳入研究的随访时间为1~49个月。按照NOS量表评价纳入研究的偏倚风险,6篇研究得分为7,5篇研究得分为8。说明纳入研究质量较高。经敏感性分析,末次随访时ICL组患者未矫正视力(UCVA)优于或等于20/20的术眼比例大于CRS组。各研究间的组间异质性较小(I_(2)=0)。经固定效应模型分析,两组比较的差异有统计学意义(RR=1.19,95%CI:1.06~1.34,P<0.05)。经敏感性分析,ICL组患者的最佳矫正视力(BCVA)增加1行及以上术眼比例大于CRS组。各研究间的组间异质性较大(I_(2)=83%)。经随机效应模型分析,两组比较的差异无统计学意义(RR=1.65,95%CI:0.94~2.90,P>0.05)。经敏感性分析,ICL组BCVA失去1行及以上的术眼比例较CRS组更低。各研究间的组间异质性较小(I_(2)=0)。经固定效应模型分析,两组比较的差异有统计学意义(RR=0.11,95%CI:0.02~0.56,P<0.05)。ICL组和CRS组并发症或二次手术总发生率分别为12.6%和20.8%。各研究间的组间异质性较小(I_(2)=45%)。经固定效应模型分析,两组比较的差异无统计学意义(RR=0.56,95%CI:0.28~1.14,P>0.05)。ICL组患者术后实际屈光度与预期屈光度差值在±0.50 D以内的比例高于CRS组。各研究间的组间异质性较小(I_(2)=0)。经固定效应模型分析,两组比较的差异有统计学意义(RR=1.31,95%CI:1.12~1.53,P<0.05)。ICL组患者术后末次随访时实际屈光度与预期屈光度差值在±1.00 D以内的比例高于CRS组。各研究的组间异质性较大(I_(2)=85%)。经随机效应模型分析,两组患者比较的差异无统计学意义(RR=1.07,95%CI:0.96~1.20,P>0.05)。结论ICL矫正高度近视眼的有效性、安全性及可预测性优于CRS,两者的并发症或二次手术总发生率相当。

Objective The aim of this study was to systematically evaluate the efficacy,safety and predictability of implantable collamer lens(ICL)and corneal refractive surgery(CRS)for high myopia.Methods The Pubmed,Embase,Cochrane Librara,and CNKI databases were searched using the subject terms(phakic intraocular lenses,keratectomy,keratomileusis,laser in situ,photorefractive keratectomy,refractive errors and myopia).The search time was from the self-built database to May 2020.All clinical controlled trials of collect randomized controlled trials and observational studies.Two researchers independently screened the literatures and extracted uncorrected visual acuity(UCVA),best corrected visual acuity(BCVA),average spherical equivalent error(SER),the scope of SER,the type of ICL and CRS.The I2 statistics were used to evaluate the heterogeneity of the data.When the heterogeneity was large(I2>50%),the random effects model was used to analysis;otherwise,the fixed effects model test was used.Binary variables was represented by risk ratio(RR)and its 95%confidence interval(CI).Results After preliminary search,476 related studies were obtained,and then the repeated,irrelevant and outcome indicators that did not meet studies were excluded.Finally,11 studies were included,with a total of 988 eyes.All studies were observational design.All subjects were adults(aged 18 or above)with high myopia or high myopic astigmatism.Patients′SER ranged from-6.00 D to-25.75 D and-6.00 D to-23.75 D in the ICL group and CRS group,respectively.The follow-up duration of included studies ranged from 1 to 49 months.There were 6 studies with 7 scores,5 studies with 8 scores according to the evaluation of risk of bias by NOS,which had high quality.During the last follow-up,the proportion of UCVA 20/20 in the ICL group was higher than that in CRS group by the sensitive-analysis.The heterogeneity of two groups was relatively small(I2=0).After the fixed effects model test,the difference between two groups was statistically significant(RR=1.19,95%CI:1.06 to 1.34,P<0.05).Compared with CRS group,ICL group had more patients gaining BCVA of 1 lines or more and less patients in losing BCVA of 1 line or more by the sensitive-analysis.The heterogeneity of two groups in gaining BCVA of 1 lines or more was relatively larger(I2=83%).After the random effects model analysis,the difference between two groups was not statistically significant(RR=1.65,95%CI:0.94~2.90,P>0.05).The heterogeneity of two groups in losing BCVA of 1 line or more was relatively small(I2=0).After the fixed effects model test,the difference between two groups was statistically significant(RR=0.11,95%CI:0.02 to 0.56,P<0.05).The secondary surgeries/complications were 12.6%and 20.8%by the sensitive-analysis.The heterogeneity of two groups was relatively small(I2=45%).After the fixed effects model test,the difference between two groups was not statistically significant(RR=0.56,95%CI:0.28 to 1.14,P>0.05).The proportion of predictability within±0.50 D and±1.00 D of the ICL group were higher than that in CRS group by the sensitive-analysis.The heterogeneity of two groups was within±0.50 D relatively small(I2=0).After the fixed effects model test,the difference between two groups was statistically significant(RR=1.31,95%CI:1.12 to 1.53,P<0.05).The heterogeneity of two groups was within±1.00 D relatively large(I2=85%).After the random effects model analysis,the difference between two groups was not statistically significant(RR=1.07,95%CI:0.96 to 1.20,P>0.05).Conclusions For the treatment of high myopia,ICL shows a better performance in terms of the efficacy,safety and predictability than CRS;while there was not statistical difference in the secondary surgeries or complications between them.