Worker's Health Department, Universidade Federal de São Paulo, São Paulo, Brazil.
Department of Ophthalmology and Visual Science, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Open-angle glaucoma (OAG) is an important cause of blindness worldwide. Laser trabeculoplasty, a treatment modality, still does not have a clear position in the treatment sequence.
To assess the effects of laser trabeculoplasty for treating OAG and ocular hypertension (OHT) when compared to medication, glaucoma surgery or no intervention. We also wished to compare the effectiveness of different laser trabeculoplasty technologies for treating OAG and OHT.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; LILACS, ClinicalTrials.gov and the WHO ICTRP. The date of the search was 28 October 2021. We also contacted researchers in the field.
We included randomised controlled trials (RCTs) comparing laser trabeculoplasty with no intervention, with medical treatment, or with surgery in people with OAG or OHT. We also included trials comparing different types of laser trabeculoplasty technologies.
We used standard methods expected by Cochrane. Two authors screened search results and extracted data independently. We considered the following outcomes at 24 months: failure to control intraocular pressure (IOP), failure to stabilise visual field progression, failure to stabilise optic neuropathy progression, adverse effects, quality of life, and costs. We graded the 'certainty' of the evidence using GRADE.
We included 40 studies (5613 eyes of 4028 people) in this review. The majority of the studies were conducted in Europe and in the USA. Most of the studies were at risk of performance and/or detection bias as they were unmasked. None of the studies were judged as having low risk of bias for all domains. We did not identify any studies of laser trabeculoplasty alone versus no intervention. Laser trabeculoplasty versus medication Fourteen studies compared laser trabeculoplasty with medication in either people with primary OAG (7 studies) or primary or secondary OAG (7 studies); five of the 14 studies also included participants with OHT. Six studies used argon laser trabeculoplasty and eight studies used selective laser trabeculoplasty. There was considerable clinical and methodological diversity in these studies leading to statistical heterogeneity in results for the primary outcome "failure to control IOP" at 24 months. Risk ratios (RRs) ranged from 0.43 in favour of laser trabeculoplasty to 1.87 in favour of medication (5 studies, I = 89%). Studies of argon laser compared with medication were more likely to show a beneficial effect compared with studies of selective laser (test for interaction P = 0.0001) but the argon laser studies were older and the medication comparator group in those studies may have been less effective. We considered this to be low-certainty evidence because the trials were at risk of bias (they were not masked) and there was unexplained heterogeneity. There was evidence from two studies (624 eyes) that argon laser treatment was associated with less failure to stabilise visual field progression compared with medication (7% versus 11%, RR 0.70, 95% CI 0.42 to 1.16) at 24 months and one further large recent study of selective laser also reported a reduced risk of failure at 48 months (17% versus 26%) RR 0.65, 95% CI 0.52 to 0.81, 1178 eyes). We judged this outcome as moderate-certainty evidence, downgrading for risk of bias. There was only very low-certainty evidence on optic neuropathy progression. Adverse effects were more commonly seen in the laser trabeculoplasty group including peripheral anterior synechiae (PAS) associated with argon laser (32% versus 26%, RR 11.74, 95% CI 5.94 to 23.22; 624 eyes; 2 RCTs; low-certainty evidence); 5% of participants treated with laser in three studies of selective laser group had early IOP spikes (moderate-certainty evidence). One UK-based study provided moderate-certainty evidence that laser trabeculoplasty was more cost-effective. Laser trabeculoplasty versus trabeculectomy Three studies compared laser trabeculoplasty with trabeculectomy. All three studies enrolled participants with OAG (primary or secondary) and used argon laser. People receiving laser trabeculoplasty may have a higher risk of uncontrolled IOP at 24 months compared with people receiving trabeculectomy (16% versus 8%, RR 2.12, 95% CI 1.44 to 3.11; 901 eyes; 2 RCTs). We judged this to be low-certainty evidence because of risk of bias (trials were not masked) and there was inconsistency between the two trials (I = 68%). There was limited evidence on visual field progression suggesting a higher risk of failure with laser trabeculoplasty. There was no information on optic neuropathy progression, quality of life or costs. PAS formation and IOP spikes were not reported but in one study trabeculectomy was associated with an increased risk of cataract (RR 1.78, 95% CI 1.46 to 2.16) (very low-certainty evidence).
AUTHORS' CONCLUSIONS: Laser trabeculoplasty may work better than topical medication in slowing down the progression of open-angle glaucoma (rate of visual field loss) and may be similar to modern eye drops in controlling eye pressure at a lower cost. It is not associated with serious unwanted effects, particularly for the newer types of trabeculoplasty, such as selective laser trabeculoplasty.
开角型青光眼(OAG)是全球重要的致盲原因之一。激光小梁成形术是一种治疗方法,但在治疗顺序中仍没有明确的地位。
评估激光小梁成形术治疗开角型青光眼和高眼压(OHT)的效果,与药物治疗、青光眼手术或不干预相比。我们还希望比较不同类型的激光小梁成形术治疗开角型青光眼和 OHT 的有效性。
我们检索了 Cochrane 中心对照试验注册库(CENTRAL)(包含 Cochrane 眼部和视觉试验注册库)(2021 年,第 10 期);Ovid MEDLINE;Ovid Embase;ISRCTN 注册库;LILACS、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台。检索日期为 2021 年 10 月 28 日。我们还联系了该领域的研究人员。
我们纳入了比较激光小梁成形术与不干预、药物治疗或手术治疗开角型青光眼或 OHT 的随机对照试验(RCT)。我们还纳入了比较不同类型的激光小梁成形术技术的试验。
我们使用了 Cochrane 预期的标准方法。两位作者独立筛选搜索结果并提取数据。我们在 24 个月时考虑了以下结局:眼压控制失败、视野进展稳定失败、视神经病变进展稳定失败、不良事件、生活质量和成本。我们使用 GRADE 评估证据的“确定性”。
我们纳入了 40 项研究(5613 只眼,4028 人)。这些研究主要在欧洲和美国进行。大多数研究都存在偏倚风险,因为它们是未被掩盖的。没有一项研究在所有领域都被认为是低偏倚风险的。我们没有发现任何关于激光小梁成形术单独与不干预比较的研究。
14 项研究比较了激光小梁成形术与药物治疗在原发性开角型青光眼(7 项研究)或原发性或继发性开角型青光眼(7 项研究)中的疗效;其中 5 项研究还纳入了 OHT 患者。6 项研究使用氩激光小梁成形术,8 项研究使用选择性激光小梁成形术。这些研究存在较大的临床和方法学差异,导致主要结局“眼压控制失败”在 24 个月时的结果存在统计学异质性。风险比(RR)范围从有利于激光小梁成形术的 0.43 到有利于药物治疗的 1.87(5 项研究,I = 89%)。与药物治疗相比,氩激光研究显示出更有利的效果,而选择性激光研究则显示出更不利的效果(检验交互作用 P = 0.0001),但氩激光研究更陈旧,且这些研究中的药物对照组可能效果较差。我们认为这是低确定性证据,因为这些试验存在偏倚风险(它们没有被掩盖),而且存在无法解释的异质性。两项研究(624 只眼)的证据表明,与药物治疗相比,氩激光治疗在 24 个月时更不易发生视野进展稳定失败(7%对 11%,RR 0.70,95%CI 0.42 至 1.16),一项新的大型选择性激光研究也报告了 48 个月时失败风险降低(17%对 26%,RR 0.65,95%CI 0.52 至 0.81,1178 只眼)。我们认为这个结局是中等确定性证据,降级为偏倚风险。视神经病变进展的证据仅为低确定性。激光小梁成形术组更常见的不良事件包括与氩激光相关的周边前粘连(PAS)(32%对 26%,RR 11.74,95%CI 5.94 至 23.22;624 只眼;2 项 RCT;低确定性证据);3 项选择性激光研究中,5%接受激光治疗的参与者出现早期眼压升高(中等确定性证据)。一项英国研究提供了中等确定性证据,表明激光小梁成形术更具成本效益。
3 项研究比较了激光小梁成形术与小梁切除术。这三项研究都纳入了开角型青光眼(原发性或继发性)患者,都使用了氩激光。与接受小梁切除术的患者相比,接受激光小梁成形术的患者在 24 个月时眼压控制失败的风险可能更高(16%对 8%,RR 2.12,95%CI 1.44 至 3.11;901 只眼;2 项 RCT)。我们认为这是低确定性证据,因为存在偏倚风险(试验未被掩盖),而且两项试验之间存在不一致性(I = 68%)。有有限的证据表明视野进展失败的风险更高,但没有关于视神经病变进展、生活质量或成本的信息。PAS 形成和眼压升高未报告,但一项研究表明小梁切除术与白内障风险增加相关(RR 1.78,95%CI 1.46 至 2.16)(低确定性证据)。
激光小梁成形术可能比局部药物治疗更能减缓开角型青光眼(视野丧失率)的进展,并且在成本较低的情况下可能与现代眼药水控制眼压的效果相似。它与严重的不良事件无关,特别是对于新型的小梁成形术,如选择性激光小梁成形术。