Riaz Yasmin, de Silva Samantha R, Evans Jennifer R
Oxford Eye Hospital, Level LG1, West Wing, John Radcliffe Hospital, Headley Way, Oxford, UK, OX3 9DU.
Cochrane Database Syst Rev. 2013 Oct 10;2013(10):CD008813. doi: 10.1002/14651858.CD008813.pub2.
Age-related cataract is a major cause of blindness and visual morbidity worldwide. It is therefore important to establish the optimal technique of lens removal in cataract surgery.
To compare manual small incision cataract surgery (MSICS) and phacoemulsification techniques.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2013), EMBASE (January 1980 to July 2013), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 2013), Web of Science Conference Proceedings Citation Index - Science (CPCI-S) (January 1970 to July 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 July 2013.
We included randomised controlled trials (RCTs) for age-related cataract that compared MSICS and phacoemulsification.
Two authors independently assessed all studies. We defined two primary outcomes: 'good functional vision' (presenting visual acuity of 6/12 or better) and 'poor visual outcome' (best corrected visual acuity of less than 6/60). We collected data on these outcomes at three and 12 months after surgery. Complications such as posterior capsule rupture rates and other intra- and postoperative complications were also assessed. In addition, we examined cost effectiveness of the two techniques. Where appropriate, we pooled data using a random-effects model.
We included eight trials in this review with a total of 1708 participants. Trials were conducted in India, Nepal and South Africa. Follow-up ranged from one day to six months, but most trials reported at six to eight weeks after surgery. Overall the trials were judged to be at risk of bias due to unclear reporting of masking and follow-up. No studies reported presenting visual acuity so data were collected on both best-corrected (BCVA) and uncorrected (UCVA) visual acuity. Most studies reported visual acuity of 6/18 or better (rather than 6/12 or better) so this was used as an indicator of good functional vision. Seven studies (1223 participants) reported BCVA of 6/18 or better at six to eight weeks (pooled risk ratio (RR) 0.99 95% confidence interval (CI) 0.98 to 1.01) indicating no difference between the MSICS and phacoemulsification groups. Three studies (767 participants) reported UCVA of 6/18 or better at six to eight weeks, with a pooled RR indicating a more favourable outcome with phacoemulsification (0.90, 95% CI 0.84 to 0.96). One trial (96 participants) reported UCVA at six months with a RR of 1.07 (95% CI 0.91 to 1.26).Regarding BCVA of less than 6/60: there were only 11/1223 events reported. The pooled Peto odds ratio was 2.48 indicating a more favourable outcome using phacoemulsification but with wide confidence intervals (0.74 to 8.28) which means that we are uncertain as to the true effect.The number of complications reported were also low for both techniques. Again this means the review is underpowered to detect a difference between the two techniques with respect to these complications. One study reported on cost which was more than four times higher using phacoemulsification than MSICS.
AUTHORS' CONCLUSIONS: On the basis of this review, removing cataract by phacoemulsification may result in better UCVA in the short term (up to three months after surgery) compared to MSICS, but similar BCVA. There is a lack of data on long-term visual outcome. The review is currently underpowered to detect differences for rarer outcomes, including poor visual outcome. In view of the lower cost of MSICS, this may be a favourable technique in the patient populations examined in these studies, where high volume surgery is a priority. Further studies are required with longer-term follow-up to better assess visual outcomes and complications which may develop over time such as posterior capsule opacification.
年龄相关性白内障是全球失明和视力损害的主要原因。因此,确定白内障手术中晶状体摘除的最佳技术很重要。
比较手法小切口白内障手术(MSICS)和超声乳化技术。
我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2013年第6期)、Ovid MEDLINE、Ovid MEDLINE在研及其他未索引引文、Ovid MEDLINE每日更新、Ovid OLDMEDLINE(1946年1月至2013年7月)、EMBASE(1980年1月至2013年7月)、拉丁美洲和加勒比卫生科学文献数据库(LILACS)(1982年1月至2013年7月)、科学网会议论文引文索引-科学版(CPCI-S)(1970年1月至2013年7月)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。我们在电子检索试验时未设置任何日期或语言限制。我们最近一次检索电子数据库是在2013年7月23日。
我们纳入了比较MSICS和超声乳化术治疗年龄相关性白内障的随机对照试验(RCT)。
两位作者独立评估所有研究。我们定义了两个主要结局:“良好的功能性视力”(呈现视力为6/12或更好)和“不良视力结局”(最佳矫正视力低于6/60)。我们在术后3个月和12个月收集这些结局的数据。还评估了诸如后囊破裂率等并发症以及其他术中及术后并发症。此外,我们考察了这两种技术的成本效益。在适当情况下,我们使用随机效应模型合并数据。
我们在本综述中纳入了8项试验,共1708名参与者。试验在印度、尼泊尔和南非进行。随访时间从1天到6个月不等,但大多数试验报告的是术后6至8周的情况。总体而言,由于遮蔽和随访报告不明确,这些试验被判定存在偏倚风险。没有研究报告呈现视力,因此我们收集了最佳矫正视力(BCVA)和未矫正视力(UCVA)的数据。大多数研究报告的视力为6/18或更好(而非6/12或更好),因此将其用作良好功能性视力的指标。7项研究(1223名参与者)报告在6至8周时BCVA为6/18或更好(合并风险比(RR)0.99,95%置信区间(CI)0.98至1.01),表明MSICS组和超声乳化组之间无差异。3项研究(767名参与者)报告在6至8周时UCVA为6/18或更好,合并RR表明超声乳化术的结局更有利(0.90,95%CI 0.84至0.96)。1项试验(96名参与者)报告了6个月时的UCVA,RR为1.07(95%CI 0.91至1.26)。关于BCVA低于6/60:仅报告了11/1223例事件。合并的Peto比值比为2.48,表明使用超声乳化术的结局更有利,但置信区间较宽(0.74至8.28),这意味着我们不确定其真实效果。两种技术报告的并发症数量也都较低。这同样意味着本综述在检测这两种技术在这些并发症方面的差异时效能不足。1项研究报告了成本,超声乳化术的成本比MSICS高出四倍多。
基于本综述,与MSICS相比,超声乳化术摘除白内障在短期内(术后3个月内)可能会带来更好的UCVA,但BCVA相似。缺乏关于长期视力结局的数据。本综述目前在检测包括不良视力结局在内的罕见结局的差异时效能不足。鉴于MSICS成本较低,在这些研究中所考察的患者群体中,MSICS可能是一种有利的技术,因为这些群体优先考虑高量手术。需要进一步进行长期随访研究,以更好地评估视力结局以及可能随时间出现的并发症,如后囊混浊。