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中华眼科医学杂志(电子版)

中华眼科医学杂志(电子版) ›› 2021, Vol. 11 ›› Issue (01) : 22 -28. doi: 10.3877/cma.j.issn.2095-2007.2021.01.004

所属专题： 青少年近视防控；

论著

飞秒激光小切口角膜基质透镜切除术与有晶状体眼后房型人工晶状体植入术矫正高度近视眼疗效的Meta分析
何海龙1, 刘振宇2, 周春媛3, 张立平4, 王进达5, 万修华5,†()   
  1. 1. 100730　首都医科大学附属北京同仁医院2018级硕士研究生
    2. 100730　首都医科大学附属北京同仁医院2019级硕士研究生
    3. 100038　首都医科大学附属北京世纪坛医院2018级硕士研究生
    4. 100045　首都医科大学附属北京儿童医院2018级硕士研究生
    5. 100730　首都医科大学附属北京同仁医院　北京同仁眼科中心　北京市眼科研究所　北京市眼科学与视觉科学重点实验室
  • 收稿日期:2020-07-30 出版日期:2021-02-28
  • 通信作者: 万修华
  • 基金资助:
    国务院妇女儿童工作委员会课题(2014108); 北京市眼科研究所突破计划(201910)

Femtosecond laser small incision lenticule extraction and posterior chamber phakic intraocular lens implantation for the correction of high myopia: a review and meta-analysis

Hailong He1, Zhenyu Liu2, Chunyuan Zhou3, Liping Zhang4, Jinda Wang5, Xiuhua Wan5,†()   

  1. 1. Master′s degree 2018, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
    2. Master′s degree 2019, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
    3. Master′s degree 2018, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
    4. Master′s degree 2018, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China
    5. Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Institute of Ophthalmology, Beijing Key Laboratory of Ophthalmology and Visual Sciences, Beijing 100730, China
  • Received:2020-07-30 Published:2021-02-28
  • Corresponding author: Xiuhua Wan
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引用本文：

何海龙, 刘振宇, 周春媛, 张立平, 王进达, 万修华. 飞秒激光小切口角膜基质透镜切除术与有晶状体眼后房型人工晶状体植入术矫正高度近视眼疗效的Meta分析[J]. 中华眼科医学杂志(电子版), 2021, 11(01): 22-28.

Hailong He, Zhenyu Liu, Chunyuan Zhou, Liping Zhang, Jinda Wang, Xiuhua Wan. Femtosecond laser small incision lenticule extraction and posterior chamber phakic intraocular lens implantation for the correction of high myopia: a review and meta-analysis[J]. Chinese Journal of Ophthalmologic Medicine(Electronic Edition), 2021, 11(01): 22-28.

目的

系统评价飞秒激光小切口角膜基质透镜切除术(SMILE)与有晶状体眼后房型人工晶状体(ICL)植入术矫正高度近视眼的效果。

方法

检索中国知网、万方数据库、维普数据库、PubMed、Medline及Cochrane Library，搜集行SMILE与ICL屈光术矫正高度近视眼的相关文献。采用Cochrane系统评价的方法，两位评价者独立进行文献检索、筛选、质量评价及数据提取。从选取的文件中提取患者的术后视力、干眼情况、手术的安全性与有效性以及术后视觉质量等结局指标。术后裸眼视力、术后最佳矫正视力、泪膜破裂时间、泪河高度、手术有效性和安全性、对比敏感度及高阶像差等结局指标均为计量资料，采用均数差(MD)及其95%置信区间(CI)作为统计分析量。各文献研究间的异质性采用Q和I2检验。如P<0.05或I2>50%则认为异质性较大。采用敏感性分析剔除发表偏倚差异较大的研究或存在高偏倚风险的研究，而后检测合并结果的稳定性，如剔除后异质性仍不显著降低，则采用随机效应模型进行分析；反之，采用固定效应模型。

结果

初步检索各数据库共获得文献59篇，去掉重复文献后剩余32篇，通过阅读文献标题、摘要及根据纳入与排除标准，剔除不符合要求的文献，最终本研究纳入7篇文献。7篇文献中行SMILE的有439只眼，植入ICL的有422只眼。各研究间患者术后最佳矫正视力和术后裸眼视力的组间异质性较大(I2＝98%和89%)。经随机效应模型分析，SMILE组与ICL组对术后最佳矫正视力的比较，差异无统计学意义(MD＝-0.02，95%CI：-0.03~0.08；P>0.05)。植入ICL组患者的术后裸眼视力较SMILE组更佳。经随机效应模型分析，两者比较的差异有统计学意义(MD＝0.04，95%CI：0.00~0.07；P<0.05)。各研究间患者术后泪河高度和泪膜破裂时间的组间异质性均较小(I2＝0)。经固定效应模型分析，两者比较的差异均无统计学意义(MD＝-0.00，-0.13，95%CI：-0.03~0.02，-0.53~0.27；P>0.05)。各研究间安全性指数和有效性指数的组间异质性均较大(I2＝92%和73%)。经随机效应模型分析，两者比较的差异均无统计学意义(MD＝-0.07，-0.03，95%CI：-0.15~0.01，-0.08~0.01；P>0.05)。多数文献对术后视觉质量的评价标准存在差异，故只对其结论进行报道，不做Meta分析。各文献均显示ICL组相较于SMILE组可以引起更低的高阶像差，ICL植入对高度近视眼患者对比敏感度的改善作用更为明显。

结论

行SMILE与植入ICL矫正高度近视眼的安全性和有效性相当，术后干眼并发症均可在短期内好转，ICL植入相较于SMILE对高度近视眼患者裸眼视力矫正效果更为理想，视觉质量改善作用更为明显。

关键词: 飞秒激光小切口角膜基质透镜切除术, 有晶状体眼后房型人工晶状体植入, 高度近视眼, Meta分析
Objective

The aim of this study was to systematically evaluate the effects of femtosecond laser small incision lenticule extraction (SMILE) and posterior chamber phakic intraocular lens (ICL) implantation for the correction of high myopia.

Methods

A literature search was implemented in CNKI, Wanfang database, VIP database, PubMed, Embase and Cochrane Library. Two researchers independently performed literature search, screening, quality evaluation, and data extraction. Postoperative visual acuity, dry eye, safety, efficacy, and postoperative visual quality were analyzed. Postoperative uncorrected visual acuity, best corrected visual acuity, tear film break-up time, tear meniscus heigh, surgical efficiency and safety, contrast sensitivity and higher-order aberrations were all measured. Mean difference (MD) and its 95% confidence interval (CI) were used as statistical analysis variables.The heterogeneity among studies was tested by Q test and I2 test. If P<0.05 or I2>50%, the heterogeneity was considered to be greater. Sensitivity analysis was used to eliminate studies with large publication bias differences or studies with high bias risk, and then the stability of the merger results was tested. If the heterogeneity was not significantly reduced after elimination, random effect model was performed; otherwise, fixed effect model was used.

Results

In all databases, 59 literatures were retrieved. After excluding the repetitive 32 literatures, the literatures with in consistent contents or incomplete main outcome indicators and the literatures with data that cannot be extracted, there were 7 studies recruited for meta-analysis, including 439 eyes with SMILE and 422 eyes implanted with ICL. There was significant heterogeneity in postoperative best corrected visual acuity between them (I2=98%) and postoperative uncorrected visual acuity (I2=89%). After random effects model analysis, there was no statistically significant difference on postoperative best corrected visual acuity (MD=-0.02, 95%CI: -0.03 to 0.08, P>0.05). The postoperative uncorrected visual acuity as an outcome indicator suggested that the ICL group performed better than the SMILE group (MD=0.04, 95%CI: 0.00 to 0.07, P<0.05). There was non-significant heterogeneity between SMILE and ICL group in postoperative tear meniscus height and breakup time (I2=0) . After fixed effects model analysis, there were no statistically significant differences on the postoperative tear meniscus height and breakup time (MD=-0.00, -0.13, 95%CI: -0.03 to 0.02, -0.53 to 0.27; P>0.05). There was significant heterogeneity in safety and efficiency index between them (I2=92%, 73%). After random effects model analysis, there was no statistically significant difference on outcome indicator of safety and efficiency index(MD=-0.07, -0.03, 95%CI: -0.15 to 0.01, -0.08 to 0.01; P>0.05). For postoperative visual quality, most literatures showed that ICL group had lower high-order aberrations compared to SMILE group. However, it was shown that there were statistical differences in other indicators, such as modulation transfer function cut off (MTF cut off), objective scattering index (OSI), and contrast sensitivity (P<0.05). ICL implantation had a more significant effect on the improvement of contrast sensitivity in patients with high myopia.

Conclusions

ICL implantation shared the same safety and efficacy with SMILE on the correction of high myopia. Postoperative dry eye complications can be improved in a short period of time. ICL implantation has a more ideal effect than SMILE on the correction of uncorrected visual acuity and a more obvious effect on the improvement of visual quality.

Key words: Small incision lenticule extraction, Posterior chamber phakic intraocular lens, High myopia, Meta-analysis
图1 文献检索与Meta分析流程图
表1 纳入研究7篇文献的基本信息(±s)
第一作者 发表年份(年) 研究类型 手术量[例数(只眼)] 屈光度(D)
SMILE ICL
Niu等[4] 2020 前瞻性非随机对照 20(37) 20(39) <-6.00
Wei等[5] 2020 前瞻性非随机对照 57(103) 57(94) -7.85±0.78或-8.07±1.03
Siedlecki等[6] 2020 匹配病例对照研究 40(80) 40(80) <-6.00
Qin等[7] 2019 回顾性分析 24(48) 24(48) -6.25~-10.00
朴勇虎等[8] 2018 回顾性分析 40(80) 36(72) -8.00~-10.00
李丽等[9] 2018 前瞻性随机对照研究 37(69) 37(65) <-6.00
徐静静等[10] 2017 回顾性分析 11(22) 12(24) <-6.00
图2 SMILE术与ICL植入术对患者术后视力影响比较的森林图　图2A和2B分别示术后最佳矫正视力和术后裸眼视力比较的森林图　注：SMILE，飞秒激光小切口角膜基质透镜切除术；ICL，有晶状体眼后房型人工晶状体植入术
图4 SMILE组与ICL组手术安全性及有效性比较的森林图　图4A和4B分别示两组手术安全性指数和有效性指数比较的森林图　注：SMILE，飞秒激光小切口角膜基质透镜切除术；ICL，有晶状体眼后房型人工晶状体植入术
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