Ghate Deepta, Wang Xue
Department of Ophthalmology and Visual Sciences, University of Nebraska Medical Center, 985540 Nebraska Medical Center, Omaha, Nebraska, USA, 68198-5540.
Cochrane Database Syst Rev. 2015 Jan 30;1:CD008213. doi: 10.1002/14651858.CD008213.pub2.
Primary congenital glaucoma (PCG) manifests within the first few years of a child's life and is not associated with any other systemic or ocular abnormalities. PCG results in considerable morbidity even in developed countries. Several surgical techniques for treating this condition, and lowering the intraocular pressure (IOP) associated with it, have been described.
To compare the effectiveness and safety of different surgical techniques for PCG.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), (January 1982 to June 2014), PubMed (January 1946 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), 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 June 2014.
We included all randomized and quasi-randomized trials in which different types of surgical interventions were compared in children under five years of age with PCG.
We used standard methodological procedures specified by The Cochrane Collaboration.
We included a total of six trials (four randomized and two quasi-randomized) with 102 eyes in 61 children. Two trials were conducted in the USA and one trial each in Egypt, Israel, Lebanon and Saudi Arabia. All trials included children aged younger than one year when diagnosed with PCG, and followed them for periods ranging from six months to five years.No two trials compared the same pair of surgical interventions, so we did not perform any meta-analysis. One trial compared trabeculotomy versus goniotomy; a second trial compared combined trabeculectomy-trabeculotomy with mitomycin C versus trabeculectomy-trabeculotomy with mitomycin C and deep sclerectomy; a third trial compared combined trabeculotomy-trabeculectomy versus trabeculotomy; a fourth trial compared one goniotomy versus two goniotomies; a fifth trial compared trabeculotomy versus viscocanalostomy; and the sixth trial compared surgical goniotomy versus neodymium-YAG laser goniotomy. For IOP change and surgical success (defined by IOP achieved), none of the trials reported a difference between pairs of surgical techniques. However, due to the limited sample sizes for all trials (average of 10 children per trial), the evidence as to whether a particular surgical technique is effective and which surgical technique is better still remains uncertain. Adverse events, such as choroidal detachment, shallow anterior chamber and hyphema, were reported from four trials. None of the trials reported quality of life or economic data.These trials were neither designed nor reported well overall. Two trials were quasi-randomized trials and judged to have high risk of selection bias; four trials were at unclear or high risk for performance bias and detection bias; and we judged one trial to have high risk of attrition bias due to high proportions of losses to follow-up. Due to poor study design and reporting, the reliability and applicability of evidence remain unclear.
AUTHORS' CONCLUSIONS: No conclusions could be drawn from the trials included in this review due to paucity of data. More research is needed to determine which of the many surgeries performed for PCG are effective.
原发性先天性青光眼(PCG)在儿童生命的最初几年内发病,且与任何其他全身或眼部异常无关。即使在发达国家,PCG也会导致相当高的发病率。已经描述了几种治疗这种疾病并降低与之相关的眼压(IOP)的手术技术。
比较不同手术技术治疗PCG的有效性和安全性。
我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视觉组试验注册库)(《Cochrane图书馆》2014年第6期)、Ovid MEDLINE、Ovid MEDLINE在研及其他非索引引文、Ovid MEDLINE日报、Ovid OLDMEDLINE(1946年1月至2014年6月)、EMBASE(1980年1月至2014年6月)、(1982年1月至2014年6月)、PubMed(1946年1月至2014年6月)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)、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使用任何日期或语言限制。我们最后一次检索电子数据库是在2014年6月23日。
我们纳入了所有随机和半随机试验,这些试验比较了5岁以下PCG儿童的不同类型手术干预。
我们采用了Cochrane协作网规定的标准方法程序。
我们共纳入了6项试验(4项随机试验和2项半随机试验),涉及61名儿童的102只眼。2项试验在美国进行,埃及、以色列、黎巴嫩和沙特阿拉伯各进行了1项试验。所有试验均纳入了诊断为PCG时年龄小于1岁的儿童,并对他们进行了6个月至5年不等的随访。没有两项试验比较相同的一对手术干预措施,因此我们未进行任何荟萃分析。一项试验比较了小梁切开术与前房角切开术;第二项试验比较了小梁切除术 - 小梁切开术联合丝裂霉素C与小梁切除术 - 小梁切开术联合丝裂霉素C及深层巩膜切除术;第三项试验比较了小梁切开术 - 小梁切除术联合与小梁切开术;第四项试验比较了一次前房角切开术与两次前房角切开术;第五项试验比较了小梁切开术与粘小管成形术;第六项试验比较了手术前房角切开术与钕 - YAG激光前房角切开术。对于眼压变化和手术成功率(根据达到的眼压定义),没有一项试验报告手术技术对之间存在差异。然而,由于所有试验的样本量有限(平均每项试验10名儿童),关于特定手术技术是否有效以及哪种手术技术更好的证据仍然不确定。四项试验报告了诸如脉络膜脱离、前房变浅和前房积血等不良事件。没有一项试验报告生活质量或经济数据。这些试验总体上设计和报告都不佳。两项试验是半随机试验,被判定存在高选择偏倚风险;四项试验存在不明确或高执行偏倚和检测偏倚风险;并且我们判定一项试验因失访比例高而存在高失访偏倚风险。由于研究设计和报告不佳,证据的可靠性和适用性仍不明确。
由于数据匮乏,本综述纳入的试验无法得出结论。需要更多研究来确定针对PCG进行的众多手术中哪些是有效的。