Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
JAMA Ophthalmol. 2021 Sep 1;139(9):983-989. doi: 10.1001/jamaophthalmol.2021.2351.
Glaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP)-lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients.
To summarize data from randomized clinical trials of MIGS for open-angle glaucoma, which were evaluated in a suite of Cochrane reviews.
The Cochrane Database of Systematic Reviews including studies published before June 1, 2021.
Reviews of randomized clinical trials comparing MIGS with cataract extraction alone, other MIGS, traditional glaucoma surgery, laser trabeculoplasty, or medical therapy.
Data were extracted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines by one investigator and confirmed by a second. Methodologic rigor was assessed using the AMSTAR 2 appraisal tool and random-effects network meta-analyses were conducted.
The proportion of participants who did not need to use medication to reduce intraocular pressure (IOP) postsurgery (drop-free). Outcomes were analyzed at short-term (<6 months), medium-term (6-18 months), and long-term (>18 months) follow-up.
Six eligible Cochrane reviews were identified discussing trabecular bypass with iStent or Hydrus microstents, ab interno trabeculotomy with Trabectome, subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. Moderate certainty evidence indicated that adding a Hydrus safely improved the likelihood of drop-free glaucoma control at medium-term (relative risk [RR], 1.6; 95% CI, 1.4 to 1.8) and long-term (RR, 1.6; 95% CI, 1.4 to 1.9) follow-up and conferred 2.0-mm Hg (95% CI, -2.7 to -1.3 mm Hg) greater IOP reduction at long-term follow-up, compared with cataract surgery alone. Adding an iStent also safely improved drop-free disease control compared with cataract surgery alone (RR, 1.4; 95% CI, 1.2 to 1.6), but the short-term IOP-lowering effect of the iStent was not sustained. Addition of a CyPass microstent improved drop-free glaucoma control compared with cataract surgery alone (RR, 1.3; 95% CI, 1.1 to 1.5) but was associated with an increased risk of vraision loss. Network meta-analyses supported the direction and magnitude of these results.
Based on data synthesized in Cochrane reviews, some MIGS may afford patients with glaucoma greater drop-free disease control than cataract surgery alone. Among the products currently available, randomized clinical trial data associate the Hydrus with greater drop-free glaucoma control and IOP lowering than the iStent; however, these effect sizes were small.
青光眼影响着全球超过 7500 万人。降低眼内压(IOP)的手术是治疗这种疾病的重要手段。为了降低手术的发病率,人们引入了微创青光眼手术(MIGS)。了解 MIGS 的比较有效性和安全性对临床医生和患者来说是必要的。
总结 MIGS 治疗开角型青光眼的随机临床试验数据,这些数据在一系列 Cochrane 综述中进行了评估。
Cochrane 系统评价数据库,包括 2021 年 6 月 1 日之前发表的研究。
比较 MIGS 与单纯白内障摘除术、其他 MIGS、传统青光眼手术、激光小梁切开术或药物治疗的随机临床试验的综述。
由一名调查员按照系统评价和荟萃分析的首选报告项目进行数据提取,并由第二名调查员确认。使用 AMSTAR 2 评估工具评估方法学严谨性,并进行随机效应网络荟萃分析。
术后不需要药物降低眼内压(IOP)的参与者比例(无滴药)。结果在短期(<6 个月)、中期(6-18 个月)和长期(>18 个月)随访中进行分析。
确定了 6 项符合条件的 Cochrane 综述,讨论了小梁旁路与 iStent 或 Hydrus 微支架、内切开小梁切除术与 Trabectome、结膜下和睫状体上引流装置以及内窥镜睫状体光凝术。中等确定性证据表明,与单纯白内障手术相比,添加 Hydrus 可安全地提高中期(相对风险 [RR],1.6;95%置信区间,1.4 至 1.8)和长期(RR,1.6;95%置信区间,1.4 至 1.9)随访时无滴药青光眼控制的可能性,并在长期随访时降低 2.0mmHg(95%置信区间,-2.7 至-1.3mmHg)的 IOP。与单纯白内障手术相比,添加 iStent 也可安全地提高无滴药疾病控制(RR,1.4;95%置信区间,1.2 至 1.6),但 iStent 的短期降压效果不能持续。添加 CyPass 微支架可提高与单纯白内障手术相比无滴药青光眼控制(RR,1.3;95%置信区间,1.1 至 1.5),但与视力丧失风险增加相关。网络荟萃分析支持这些结果的方向和幅度。
基于 Cochrane 综述中综合的数据,一些 MIGS 可能为青光眼患者提供比单纯白内障手术更好的无滴药疾病控制。在目前可用的产品中,与 iStent 相比,Hydrus 与更大的无滴药青光眼控制和 IOP 降低相关;然而,这些效果大小很小。