Hu Kuang, Gazzard Gus, Bunce Catey, Wormald Richard
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road, London, UK.
Cochrane Database Syst Rev. 2016 Aug 15(8):CD011693. doi: 10.1002/14651858.CD011693.pub2.
Glaucoma is the leading cause of irreversible blindness. Minimally invasive surgical techniques, such as ab interno trabecular bypass surgery, have been introduced to prevent glaucoma progressing.
The main objective was to assess the results at two years of ab interno trabecular bypass surgery with Trabectome for open angle glaucoma in comparison to conventional medical, laser, or surgical treatment in terms of efficacy and safety. A secondary objective was to examine the effects of Trabectome surgery in people who have concomitant phacoemulsification in comparison to those who do not have concomitant phacoemulsification.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2016), EMBASE (January 1980 to May 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (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 12 May 2016.
We included only randomised controlled trials (RCTs) of ab interno trabecular bypass surgery with Trabectome.
We planned to have two review authors independently extract data from reports of included studies using a data collection form.
One randomised controlled trial identified from ClinicalTrials.gov, NCT00901108, met the criteria for inclusion. This study has subsequently been terminated. The ClinicalTrials.gov record indicates that the investigators plan to complete 12 months of follow-up and analysis on 19 participants already recruited into the trial.
AUTHORS' CONCLUSIONS: There is currently no high-quality evidence for the outcomes of ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Properly designed RCTs are needed to assess the long-term efficacy and safety of this technique.
青光眼是不可逆性失明的主要原因。已引入诸如内路小梁旁路手术等微创外科技术来预防青光眼进展。
主要目的是评估内路小梁旁路手术联合 Trabectome 治疗开角型青光眼两年时的疗效和安全性,并与传统药物、激光或手术治疗进行比较。次要目的是研究与未同时行白内障超声乳化术的患者相比,同时行白内障超声乳化术的患者接受 Trabectome 手术的效果。
我们检索了 CENTRAL(其中包含 Cochrane 眼科和视力试验注册库)(2016 年第 4 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 2016 年 5 月)、EMBASE(1980 年 1 月至 2016 年 5 月)、ISRCTN 注册库(www.isrctn.com/editAdvancedSearch)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。在电子检索试验时,我们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的时间为 2016 年 5 月 12 日。
我们仅纳入了内路小梁旁路手术联合 Trabectome 的随机对照试验(RCT)。
我们计划让两位综述作者使用数据收集表从纳入研究的报告中独立提取数据。
从 ClinicalTrials.gov 识别出的一项随机对照试验 NCT00901108 符合纳入标准。该研究随后已终止。ClinicalTrials.gov 记录表明,研究人员计划对已纳入试验的 19 名参与者完成 12 个月的随访和分析。
目前尚无关于内路小梁旁路手术联合 Trabectome 治疗开角型青光眼疗效的高质量证据。需要设计合理的随机对照试验来评估该技术的长期疗效和安全性。