Tseng Victoria L, Coleman Anne L, Chang Melinda Y, Caprioli Joseph
Stein Eye Institute, UCLA, 100 Stein Plaza, Los Angeles, California, USA, 90025.
Cochrane Database Syst Rev. 2017 Jul 28;7(7):CD004918. doi: 10.1002/14651858.CD004918.pub3.
Aqueous shunts are employed to control intraocular pressure (IOP) for people with primary or secondary glaucomas who fail or are not candidates for standard surgery.
To assess the effectiveness and safety of aqueous shunts for reducing IOP in glaucoma compared with standard surgery, another type of aqueous shunt, or modification to the aqueous shunt procedure.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 8), MEDLINE Ovid (1946 to August 2016), Embase.com (1947 to August 2016), PubMed (1948 to August 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to August 2016), ClinicalTrials.gov (www.clinicaltrials.gov); searched 15 August 2016, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 15 August 2016. We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 15 August 2016. We also searched the reference lists of identified trial reports and the Science Citation Index to find additional trials.
We included randomized controlled trials that compared various types of aqueous shunts with standard surgery or to each other in eyes with glaucoma.
Two review authors independently screened search results for eligibility, assessed the risk of bias, and extracted data from included trials. We contacted trial investigators when data were unclear or not reported. We graded the certainty of the evidence using the GRADE approach. We followed standard methods as recommended by Cochrane.
We included 27 trials with a total of 2099 participants with mixed diagnoses and comparisons of interventions. Seventeen studies reported adequate methods of randomization, and seven reported adequate allocation concealment. Data collection and follow-up times varied.Four trials compared an aqueous shunt (Ahmed or Baerveldt) with trabeculectomy, of which three reported one-year outcomes. At one-year, the difference in IOP between aqueous shunt groups and trabeculectomy groups was uncertain (mean difference (MD) 2.55 mmHg, 95% confidence interval (CI) -0.78 to 5.87; 380 participants; very low-certainty evidence). The difference in logMAR visual acuity was also uncertain (MD 0.12 units, 95% CI -0.07 to 0.31; 380 participants; very low-certainty evidence). In two trials, the difference in visual field score was uncertain (MD -0.25, 95% CI -1.91 to 1.40; 196 participants; very low-certainty evidence). The mean number of antiglaucoma medications was higher in the aqueous shunt group than the trabeculectomy group in one trial (MD 0.80, 95% CI 0.48 to 1.12; 184 participants; low-certainty evidence). The effect on needing additional glaucoma surgery was uncertain between groups in two trials (risk ratio (RR) 0.24, 95% CI 0.04 to 1.36; 329 participants; very low-certainty evidence). In one trial, fewer total adverse events were reported in the aqueous shunt group than the trabeculectomy group (RR 0.59, 95% CI 0.43 to 0.81; 212 participants; very low-certainty evidence). No trial reported quality-of-life outcomes at one-year follow-up.Two trials that compared the Ahmed implant with the Baerveldt implant for glaucoma found higher mean IOP in the Ahmed group at one-year follow-up (MD 2.60 mmHg, 95% CI 1.58 to 3.62; 464 participants; moderate-certainty evidence). The difference in logMAR visual acuity was uncertain between groups (MD -0.07 units, 95% CI -0.27 to 0.13; 501 participants; low-certainty evidence). The MD in number of antiglaucoma medications was within one between groups (MD 0.35, 95% CI 0.11 to 0.59; 464 participants; moderate-certainty evidence). More participants in the Ahmed group required additional glaucoma surgery than the Baerveldt group (RR 2.77, 95% CI 1.02 to 7.54; 514 participants; moderate-certainty evidence). The two trials reported specific adverse events but not overall number of adverse events. Neither trial reported visual field or quality-of-life outcomes at one-year follow-up.One trial compared the Ahmed implant with the Molteno implant for glaucoma over two-year follow-up. Mean IOP was higher in the Ahmed group than the Molteno group (MD 1.64 mmHg, 95% CI 0.85 to 2.43; 57 participants; low-certainty evidence). The differences in logMAR visual acuity (MD 0.08 units, 95% CI -0.24 to 0.40; 57 participants; very low-certainty evidence) and mean deviation in visual field (MD -0.18 dB, 95% CI -3.13 to 2.77; 57 participants; very low-certainty evidence) were uncertain between groups. The mean number of antiglaucoma medications was also uncertain between groups (MD -0.38, 95% CI -1.03 to 0.27; 57 participants; low-certainty evidence). The trial did not report the proportion needing additional glaucoma surgery, total adverse events, or quality-of-life outcomes.Two trials compared the double-plate Molteno implant with the Schocket shunt for glaucoma; one trial reported outcomes only at six-month follow-up, and the other did not specify the follow-up time. At six-months, mean IOP was lower in the Molteno group than the Schocket group (MD -2.50 mmHg, 95% CI -4.60 to -0.40; 115 participants; low-certainty evidence). Neither trial reported the proportion needing additional glaucoma surgery, total adverse events, or visual acuity, visual field, or quality-of-life outcomes.The remaining 18 trials evaluated modifications to aqueous shunts, including 14 trials of Ahmed implants (early aqueous suppression versus standard medication regimen, 2 trials; anti-vascular endothelial growth factor agent versus none, 4 trials; corticosteroids versus none, 2 trials; shunt augmentation versus none, 3 trials; partial tube ligation versus none, 1 trial; pars plana implantation versus conventional implantation, 1 trial; and model M4 versus model S2,1 trial); 1 trial of 500 mm Baerveldt versus 350 mm Baerveldt; and 3 trials of Molteno implants (single-plate with oral corticosteroids versus single-plate without oral corticosteroids, 1 trial; double-plate versus single-plate, 1 trial; and pressure-ridge versus double-plate with tube ligation, 1 trial).
AUTHORS' CONCLUSIONS: Information was insufficient to conclude whether there are differences between aqueous shunts and trabeculectomy for glaucoma treatment. While the Baerveldt implant may lower IOP more than the Ahmed implant, the evidence was of moderate-certainty and it is unclear whether the difference in IOP reduction is clinically significant. Overall, methodology and data quality among existing randomized controlled trials of aqueous shunts was heterogeneous across studies, and there are no well-justified or widely accepted generalizations about the superiority of one surgical procedure or device over another.
对于原发性或继发性青光眼患者，当标准手术失败或不适合进行标准手术时，可采用房水引流装置来控制眼压（IOP）。
评估与标准手术、另一种房水引流装置或房水引流手术改良方法相比，房水引流装置降低青光眼患者眼压的有效性和安全性。
我们检索了Cochrane中心对照试验注册库（CENTRAL，其中包含Cochrane眼科和视力试验注册库）（2016年第8期）、MEDLINE Ovid（1946年至2016年8月）、Embase.com（1947年至2016年8月）、PubMed（1948年至2016年8月）、LILACS（拉丁美洲和加勒比卫生科学文献数据库）（1982年至2016年8月）、ClinicalTrials.gov（www.clinicaltrials.gov）；检索日期为2016年8月15日，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）；检索日期为2016年8月15日。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2016年8月15日。我们还检索了已识别试验报告的参考文献列表和科学引文索引以查找其他试验。
我们纳入了比较各种房水引流装置与标准手术或在青光眼患者眼中相互比较的随机对照试验。
两位综述作者独立筛选检索结果以确定其是否符合纳入标准，评估偏倚风险，并从纳入的试验中提取数据。当数据不清楚或未报告时，我们会联系试验研究者。我们使用GRADE方法对证据的确定性进行分级。我们遵循Cochrane推荐的标准方法。
我们纳入了27项试验，共有2099名参与者，其诊断和干预比较混合。17项研究报告了充分的随机化方法，7项报告了充分的分配隐藏。数据收集和随访时间各不相同。4项试验比较了房水引流装置（艾哈迈德或贝尔维尔德）与小梁切除术，其中3项报告了一年的结果。在一年时，房水引流装置组和小梁切除术组之间的眼压差异不确定（平均差（MD）2.55 mmHg，95%置信区间（CI）-0.78至5.87；380名参与者；极低确定性证据）。对数最小分辨角视力差异也不确定（MD 0.12单位，95% CI -0.07至0.31；380名参与者；极低确定性证据）。在两项试验中，视野评分差异不确定（MD -0.25，95% CI -1.91至1.40；196名参与者；极低确定性证据）。在一项试验中，房水引流装置组的抗青光眼药物平均数量高于小梁切除术组（MD
