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年龄相关性白内障超声乳化手术中不同大小切口的研究

Different-sized incisions for phacoemulsification in age-related cataract.

作者信息

Jin Chongfei, Chen Xinyi, Law Andrew, Kang Yunhee, Wang Xue, Xu Wen, Yao Ke

机构信息

Eye Center of the Second Affiliated Hospital, Medical College of Zhejiang University, 88 Jiefang Road, Hangzhou, China, 310009.

出版信息

Cochrane Database Syst Rev. 2017 Sep 20;9(9):CD010510. doi: 10.1002/14651858.CD010510.pub2.

Abstract

BACKGROUND

Age-related cataract is the principal cause of blindness and visual impairment in the world. Phacoemulsification is the main surgical procedure used to treat cataract. The comparative effectiveness and safety of different-sized incisions for phacoemulsification has not been determined.

OBJECTIVES

The aim of this systematic review was to assess the effectiveness and safety of smaller versus larger incisions for phacoemulsification in age-related cataract. The primary outcome of this review was surgically induced astigmatism at three months after surgery.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 10), MEDLINE Ovid (1946 to 28 October 2016), Embase Ovid (1947 to 28 October 2016), PubMed (1948 to 28 October 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 28 October 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com; last searched 13 May 2013), ClinicalTrials.gov (www.clinicaltrials.gov; searched 28 October 2016), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp; searched 28 October 2016). We did not use any date or language restrictions in the electronic searches for trials.

SELECTION CRITERIA

We included randomized controlled trials (RCTs) comparing different-sized incisions in people with age-related cataract undergoing phacoemulsification.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane.

MAIN RESULTS

We included 26 RCTs with a total of 2737 participants (3120 eyes). These trials were conducted in Bosnia and Herzegovina, China, France, India, Italy, Korea, Spain, Switzerland, and Turkey. Half of the 26 trials were conducted in China. We judged all trials as mostly at unclear to low risk of bias. The included RCTs compared four different-sized incisions:<= 1.5 mm, 1.8 mm, 2.2 mm, and approximately 3.0 mm. These incisions were performed using three different techniques: coaxial and biaxial microincision phacoemulsification (C-MICS and B-MICS) and standard phacoemulsification. Not all studies provided data in a form that could be included in this review. Five studies had three arms.Fifteen trials compared C-MICS (2.2 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less surgically induced astigmatism in the C-MICS group at three months compared with standard phacoemulsification (mean difference (MD) -0.19 diopters (D), 95% confidence interval (CI) -0.30 to -0.09; 996 eyes; 8 RCTs). There was low-certainty evidence that both groups achieved similar best-corrected visual acuity (MD 0.00 logMAR, 95% CI -0.02 to 0.02; 242 eyes; 3 RCTs). There was low-certainty evidence of little or no difference in endothelial cell loss and central corneal thickness comparing C-MICS with standard phacoemulsification (MD -7.23 cells/mm, 95% CI -78.66 to 64.20; 596 eyes; 4 RCTs) and (MD -0.68 μm, 95% CI -3.26 to 1.90; 487 eyes; 5 RCTs).Nine trials compared C-MICS (1.8 mm) with standard phacoemulsification (about 3.0 mm). Very low-certainty evidence suggested less astigmatism at three months in the C-MICS group compared with standard phacoemulsification group (MD -0.23 D, 95% CI -0.34 to -0.13; 561 eyes; 5 RCTs). Low-certainty evidence suggested little or no difference in best-corrected visual acuity, endothelial cell loss, and central corneal thickness in the two groups at three months (MD -0.02 logMAR, 95% CI -0.03 to -0.00; 192 eyes; 3 RCTs), (MD 7.56 cells/mm, 95% CI -67.65 to 82.77; 380 eyes; 5 RCTs), and (MD -1.52 μm, 95% CI -6.29 to 3.25; 245 eyes; 3 RCTs).Six studies compared C-MICS (1.8 mm) with C-MICS (2.2 mm). There was low-certainty evidence that astigmatism, visual acuity, and central corneal thickness were similar in the two groups at three months (MD 0.04 D, 95% CI -0.09 to 0.16; 259 eyes; 3 RCTs), (MD 0.01 logMAR, 95% CI -0.01 to 0.04; 200 eyes; 3 RCTs), and (MD 0.45 μm, 95% CI -2.70 to 3.60; 100 eyes; 1 RCT). Very low-certainty evidence suggested higher endothelial cell loss in the 1.8 mm group (MD 213.00 cells/mm, 95% CI 11.15 to 414.85; 70 eyes; 1 RCT).Four studies compared B-MICS (<= 1.5 mm) with standard phacoemulsification (about 3.0 mm). Astigmatism was similar in the two groups at three months (MD -0.01 D, 95% CI -0.03 to 0.01; 368 eyes; 2 RCTs; moderate-certainty evidence). There was low-certainty evidence on visual acuity, suggesting little or no difference between the two groups (MD -0.02 logMAR, 95% CI -0.04 to -0.00; 464 eyes; 3 RCTs). Low-certainty evidence on endothelial cell loss and central corneal thickness also suggested little or no difference between the two groups (MD 55.83 cells/mm, 95% CI -34.93 to 146.59; 280 eyes; 1 RCT) and (MD 0.10 μm, 95% CI -14.04 to 14.24; 90 eyes; 1 RCT).None of the trials reported on quality of life. One trial reported that no participants experienced endophthalmitis or posterior capsule rupture; they also reported little or no difference between incision groups regarding corneal edema (risk ratio 1.02, 95% CI 0.40 to 2.63; 362 eyes).

AUTHORS' CONCLUSIONS: Phacoemulsification with smaller incisions was not consistently associated with less surgically induced astigmatism compared with phacoemulsification with larger incisions. Coaxial microincision phacoemulsification may be associated with less astigmatism than standard phacoemulsification, but the difference was small, in the order of 0.2 D, and the evidence was uncertain. Safety outcomes and quality of life were not adequately reported; these should be addressed in future studies.

摘要

背景

年龄相关性白内障是全球失明和视力损害的主要原因。超声乳化术是治疗白内障的主要外科手术。不同大小切口的超声乳化术的相对有效性和安全性尚未确定。

目的

本系统评价旨在评估年龄相关性白内障超声乳化术中较小切口与较大切口的有效性和安全性。本评价的主要结局是术后三个月手术引起的散光。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)(其中包含Cochrane眼科和视力试验注册库)(2016年第10期)、MEDLINE Ovid(1946年至2016年10月28日)、Embase Ovid(1947年至2016年10月28日)、PubMed(1948年至2016年10月28日)、LILACS(拉丁美洲和加勒比卫生科学文献数据库)(1982年至2016年10月28日)、对照试验元注册库(mRCT)(www.controlled-trials.com;最后检索时间为2013年5月13日)、ClinicalTrials.gov(www.clinicaltrials.gov;检索时间为2016年10月28日)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp;检索时间为2016年10月28日)。我们在电子检索试验时未使用任何日期或语言限制。

选择标准

我们纳入了比较年龄相关性白内障患者接受超声乳化术时不同大小切口的随机对照试验(RCT)。

数据收集与分析

我们采用了Cochrane期望的标准方法程序。

主要结果

我们纳入了26项RCT,共2737名参与者(3120只眼)。这些试验在波斯尼亚和黑塞哥维那、中国、法国、印度、意大利、韩国、西班牙、瑞士和土耳其进行。26项试验中有一半在中国进行。我们将所有试验判定为偏倚风险大多为不清楚至低。纳入的RCT比较了四种不同大小的切口:≤1.5mm、1.8mm、2.2mm和约3.0mm。这些切口采用三种不同技术进行:同轴和双轴微切口超声乳化术(C-MICS和B-MICS)以及标准超声乳化术。并非所有研究都以可纳入本评价的形式提供数据。五项研究有三个组。15项试验比较了C-MICS(2.2mm)与标准超声乳化术(约3.0mm)。极低确定性证据表明,与标准超声乳化术相比,C-MICS组术后三个月手术引起的散光较少(平均差(MD)-0.19屈光度(D),95%置信区间(CI)-0.30至-0.09;996只眼;8项RCT)。低确定性证据表明两组的最佳矫正视力相似(MD 0.00 logMAR,95%CI -0.02至0.02;242只眼;3项RCT)。低确定性证据表明,比较C-MICS与标准超声乳化术时,内皮细胞丢失和中央角膜厚度几乎没有差异(MD -7.23个细胞/mm,95%CI -78.66至64.20;596只眼;4项RCT)以及(MD -0.68μm,95%CI -3.26至1.90;487只眼;五项RCT)。9项试验比较了C-MICS(1.8mm)与标准超声乳化术(约3.0mm)。极低确定性证据表明,与标准超声乳化术组相比,C-MICS组术后三个月散光较少(MD -0.23 D,95%CI -0.34至-0.13;561只眼;5项RCT)。低确定性证据表明,两组术后三个月的最佳矫正视力、内皮细胞丢失和中央角膜厚度几乎没有差异(MD -0.02 logMAR,95%CI -0.03至-0.00;192只眼;3项RCT),(MD 7.56个细胞/mm,95%CI -67.65至82.77;380只眼;5项RCT)以及(MD -1.52μm,95%CI -6.29至3.25;2百45只眼;3项RCT)。6项研究比较了C-MICS(1.8mm)与C-MICS(2.2mm)。低确定性证据表明,两组术后三个月散光、视力和中央角膜厚度相似(MD +0.04 D,95%CI -0.09至0.16;259只眼;3项RCT),(MD 0.01 logMAR,95%CI -0.01至0.04;200只眼;3项RCT)以及(MD 0.45μm,95%CI -2.70至3.6;100只眼;1项RCT)。极低确定性证据表明,1.8mm组内皮细胞丢失较高(MD 213.00个细胞/mm,95%CI 11.15至414.85;70只眼;1项RCT)。4项研究比较了B-MICS(≤1.5mm)与标准超声乳化术(约3.0mm)。两组术后三个月散光相似(MD -0.01 D,95%CI -0.03至0.01;368只眼;2项RCT;中度确定性证据)。关于视力的低确定性证据表明,两组之间几乎没有差异(MD -0.02 logMAR,95%CI -0.04至-0.00;464只眼;3项RCT)。关于内皮细胞丢失和中央角膜厚度的低确定性证据也表明,两组之间几乎没有差异(MD 55.83个细胞/mm,95%CI -34.93至146.59;280只眼;1项RCT)以及(MD 0.10μm,95%CI -14.04至14.24;90只眼;1项RCT)。没有试验报告生活质量。一项试验报告称,没有参与者发生眼内炎或后囊破裂;他们还报告说,切口组之间角膜水肿几乎没有差异(风险比1.02,95%CI 0.40至2.63;362只眼)。

作者结论

与较大切口的超声乳化术相比,较小切口的超声乳化术与较少的手术引起的散光并不始终相关。同轴微切口超声乳化术可能比标准超声乳化术引起的散光少,但差异很小,约为0.2 D,且证据不确定。安全性结局和生活质量报告不足;这些应在未来研究中加以解决。

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