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中华眼科医学杂志(电子版) ›› 2017, Vol. 07 ›› Issue (01) : 25 -31. doi: 10.3877/cma.j.issn.2095-2007.2017.01.005

所属专题： 青少年近视防控； 文献；

论著

周边离焦软性角膜接触镜与单焦点软性角膜接触镜对青少年近视进展控制效果的Meta分析
杨洋1, 张明洲1, 吕会斌1, 江晓丹1, 刘嫣1, 李学民1,†()   
  1. 1. 100191　北京大学第三医院眼科
  • 收稿日期:2016-12-13 出版日期:2017-02-28
  • 通信作者: 李学民
  • 基金资助:
    首都临床特色应用研究专项特色项目(A72502－03)

Meta-analysis of the effect of peripheral soft corneal contact lens and single focus soft corneal contact lens on juvenile myopia progression

Yang Yang1, Mingzhou Zhang1, Huibin Lv1, Xiaodan Jiang1, Yan Liu1, Xuemin Li1,†()   

  1. 1. Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China
  • Received:2016-12-13 Published:2017-02-28
  • Corresponding author: Xuemin Li
  • About author:
    Corresponding author: Li Xuemin, Email:
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引用本文：

杨洋, 张明洲, 吕会斌, 江晓丹, 刘嫣, 李学民. 周边离焦软性角膜接触镜与单焦点软性角膜接触镜对青少年近视进展控制效果的Meta分析[J]. 中华眼科医学杂志(电子版), 2017, 07(01): 25-31.

Yang Yang, Mingzhou Zhang, Huibin Lv, Xiaodan Jiang, Yan Liu, Xuemin Li. Meta-analysis of the effect of peripheral soft corneal contact lens and single focus soft corneal contact lens on juvenile myopia progression[J]. Chinese Journal of Ophthalmologic Medicine(Electronic Edition), 2017, 07(01): 25-31.

目的

采用Meta分析的方法系统评价周边离焦软性角膜接触镜(PDSCLs)与单焦点软性角膜接触镜(SVSCLs)对青少年近视进展控制的效果。

方法

利用计算机检索MEDLINE、EMBASE及Cochrane Library数据库，在检索结果且纳入研究的病例中，将使用PDSCLs者列为干预组，将使用SVSCLs或框架眼镜者列为对照组，参与者均为学龄儿童。采用Cochrane系统评价的方法，由两名评价员独立地收集数据。从选取的研究中提取信息(包括作者、发表年份、国家或地区、研究中心、数量、年龄、近用附加值、样本量、随访时间、失访人数、干预措施、结果及试验方法等)，并通过Downs and Black评分系统评估纳入研究的文献质量。干预组与对照组中屈光度和眼轴长度变化的差值通过加权均数差(WMD)计算，并计算两者的95%可信区间。通过I2统计检验异质性，当P<0.1(或I2> 50%)时，异质性显著，采用随机效应模型(I－V异质性)来评估；否则，采用固定效应模型(逆方差)来评估。两组屈光度及眼轴长度的比较采用Z检验。

结果

共检索到542项研究，其中5项高质量的临床试验符合本研究的纳入标准，最终有4项研究纳入Meta分析，包括310例配戴PDSCLs和298例配戴SVSCLs的儿童。对照组的研究中有1项采用框架眼镜，其余3项采用SVSCLs。全部研究均为单中心。在这些研究中，有1项为交叉试验，为防止两个干预期之间存在用药间隔时间，本研究仅纳入第一次干预的结果。4项研究中有3项是非随机对照试验，其余1项是随机对照试验(RCT)。干预组1项研究的近用附加值为＋2.50 D，其余3项近用附加值为＋2.00 D。4项研究的随访时间为10～24个月。与使用SVSCLs相比，使用PDSCLs可延缓近视儿童的屈光度进展0.27 D(95%可信区间：0.20～0.34)，差异有统计学意义(Z＝7.78，P<0.05)；此外，使用PDSCLs还可减慢眼轴长度增长0.12 mm(95%可信区间：－0.15～－0.09)，但经过统计学分析差异尚无统计学意义(Z＝0.54，P>0.05)，有待于扩大样本进一步研究。在12个月和24个月随访期间，干预组和对照组间屈光度进展的WMD分别为0.29 D(95%可信区间：0.20～0.39)和0.13 mm(95%可信区间：－0.17～0.08)。干预组和对照组间眼轴长度变化的WMD分别为0.26 D(95%可信区间：0.15～0.36)和0.12 mm(95%可信区间：－0.17～0.07)。

结论

总体而言，与SVSCLs相比，PDSCLs可更有效地减缓近视眼的发展。但结果的可靠性有待进一步研究。

关键词: 近视眼, 周边离焦, 单焦点, 多焦点, 角膜接触镜, Meta分析
Objective

Meta-analysis was used to evaluate the effect of peripheral defocus soft corneal contact lens (PDSCLs) and single vision soft contact lens (SVSCLs) on the control of juvenile myopia.

Methods

MEDLINE, EMBASE and Cochrane retrieval Library database by computer, and the search results are included in the study cases, will use PDSCLs as intervention group, will use SVSCLs or glasses as a control group, participants were school-age children. Using the evaluation method of Cochrane system, two reviewers independently collected data to extract information from the selected study (including the author, publication year, country or region, research center, quantity, age, with added value, sample size, follow-up time, the number of lost, intervention measures and results and test methods), and through the Downs and Black scoring system to assess the quality of clinical trial included in the test. In two intervention groups, the difference of diopter and eye axis was calculated by weighted mean difference (WMD), and the 95% confidence intervals were calculated. Heterogeneity was examined by I2 statistics, when the P<0.1 (or I2>50%) was estimated using a random effects model (I-V heterogeneity) to account for significant heterogeneity. Otherwise, we use the fixed effects model (inverse variance) to evaluate. The two groups of refraction and axial length werecompared using Z test.

Results

A total of 542 studies were retrieved, of which a total of 5 high quality clinical trials met the inclusion criteria of the study. In the end, a total of 4 studies were included in the Meta analysis, including 310 cases of wearing PDSCLs and 298 cases of wearing SVSCLs. All studies were single center. In these studies, there was a crossover trial, in order to prevent the time interval between the two dry expectations, this study included only the results of the first intervention. Three of the four studies were randomized controlled trials, and the other one was randomized controlled trial (RCT). In the intervention group, the added value of the one studies was + 2.50 D, and the other 3 items were + 2.00 D. 4 patients were followed up for a period of 10 to 24 months. Compared with SVSCLs, PDSCLs delay the progression of myopia in children with myopia of 0.27 D (95% confidence interval: 0.20~0.34), the difference was statistically significant (Z=7.78, P<0.05); slow axial length growth of 0.12 mm (95% confidence interval: -0.15~-0.09), the difference was not statistically significant (Z=0.54, P>0.05), need to expand the sample for further study. During the follow-up period of 12 and 24 months, the WMD of the refractive index of the intervention group and the control group were 0.29 D (95% confidence interval: 0.20~0.39) and 0.13 mm (95% confidence interval: -0.17~0.08). The WMD of the axial length of the intervention group and the control group were 0.26 D (95% confidence interval: 0.15~0.36) and 0.12 mm (95% confidence interval: -0.17~0.07).

Conclusion

Overall, compared with SVSCLs, PDSCLs is more effective in slowing the development of myopia, while the reliability of the results need to be further studied.

Key words: Myopia, Peripheral defocus, Single vision, Dual focus, Multifocal, Meta-analysis
图1 研究筛选流程图
表1 纳入分析的文献的基本情况
通讯作者(年份) 国家或地区 研究中心 眼数[(左/右)，例] 年龄(岁) 试验设计 近用附加值(D) 盲法 随访时间(月)
Jian Ge(2011) 中国 单中心 164(86/78) 7～14 非RCT ＋2.00 无 12
Chi Ho To (2014) 香港 单中心 256(130/126) 8～13 非RCT ＋2.50 双盲 24
John R. Phillips (2010) 新西兰 单中心 70(35/35) 11～14 RCT ＋2.00 研究者设盲 10
Jeffrey (2013)1 美国 单中心 64(32/32) 8～11 非RCT ＋2.00 无 12
Jeffrey (2013)2 美国 单中心 54(27/27) 8～11 非RCT ＋2.00 无 24
图2 干预组与对照组屈光度变化的Meta分析
图3 排除Jeffrey的研究后干预组与对照组屈光度变化的Meta分析
图4 干预组与对照组眼轴长度变化的Meta分析
图5 排除Jeffrey的研究后干预组与对照组眼轴长度变化的Meta分析
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