Warwick Medical School, University of Warwick, Coventry, UK.
University Hospital of Wales, Cardiff, UK.
Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD006746. doi: 10.1002/14651858.CD006746.pub4.
In at least a third of primary angle closure cases, appositional angle closure persists after laser peripheral iridotomy, and further intervention may be considered. Laser peripheral iridoplasty (LPIp) can be used in treating chronic angle closure when angle closure persists after laser peripheral iridotomy. Previous reviews have found insufficient data to determine its clinical effectiveness, compared to other interventions. This is an update of a Cochrane Review first published in 2008 and updated in 2012. It examines all studies to date to establish whether LPIp shows any effectiveness over other available treatment options.
To assess the effectiveness of laser peripheral iridoplasty in the treatment of people with chronic angle closure, when compared to laser peripheral iridotomy, medical therapy or no further treatment.
We searched various electronic databases. The date of the search was 20 December 2020.
We included only randomised controlled trials (RCTs) assessing the use of LPIp in cases of suspected primary angle closure (PACS), confirmed primary angle closure (PAC), or primary chronic angle-closure glaucoma (PACG). We applied no restrictions with respect to gender, age or ethnicity of participants. Trials evaluating LPIp for acute attacks of angle closure were not eligible.
We used standard methodological procedures expected by Cochrane. Two authors independently assessed studies for risk of bias using Cochrane's 'risk of bias' tool. We collected adverse effects information from the trials.
We included four RCTs involving 252 participants (276 eyes). In total, three different methods of intervention were used and 15 outcomes reported, with different time points. We used narrative synthesis to describe the majority of the findings, as meta-analysis was only possible for a limited number of outcomes due to the variation in study design and outcomes assessed. Study Characteristics Participants were adults recruited from outpatient settings in the UK, Singapore, China and Korea with either PACS, PAC or PACG. All studies compared argon LPIp (as either a primary or secondary procedure) to an alternative intervention or no further treatment. Three studies were of parallel group design, and one within-person, randomised by eye. All studies showed elements of high risk of bias. Due to the nature of the intervention assessed, a lack of masking of both participants and assessors was noted in all trials. Findings Laser peripheral iridoplasty with iridotomy versus iridotomy alone as a primary procedure Two RCTs assessed the use of argon LPIp as a primary procedure with peripheral iridotomy, compared with peripheral iridotomy alone. However, neither study reported data for the primary outcome, disease progression. Argon LPIp showed no evidence of effect on: final mean intraocular pressure (IOP) at 3 months and 12 months (mean difference (MD) 0.39 mmHg, 95% confidence interval (CI) -1.07 to 1.85; I = 38%; 2 studies, 174 participants; low-certainty evidence); further surgical or laser intervention at 12 months (risk ratio (RR) 1.21, 95% CI 0.66 to 2.21; 1 study, 126 participants; low-certainty evidence); or mean number of additional medications required at 12 months (MD 0.10, 95% CI -0.34 to 0.54; 1 study, 126 participants; low-certainty evidence). Complications were assessed at 3 to 12 months (2 studies, 206 participants; low-certainty evidence) and found to be mild and uncommon, with comparable levels between groups. The only severe complication encountered was one case of malignant glaucoma in one study's argon LPIp group. Quality of life measures were not assessed. In the other study, investigators found that argon LPIp showed no evidence of effect on final mean anterior segment optical coherence tomography (AS-OCT) measurements, including anterior chamber depth (MD 0.00 mm, 95% CI -0.10 to 0.10; 24 participants, 48 eyes; very low-certainty evidence). Laser peripheral iridoplasty as a secondary procedure versus no treatment One RCT assessed the use of argon LPIp as a secondary procedure compared with no further treatment in 22 participants over three months. Disease progression, additional medications required, complications, further surgical or laser intervention, and quality of life outcomes were not assessed. There was only very low-certainty evidence regarding final maximum IOP value (MD -1.81 mmHg, 95% CI -3.11 to -0.51; very low-certainty evidence), with no evidence of effect on final minimum IOP values (MD -0.31 mmHg, 95% CI -1.93 to 1.31; very low-certainty evidence). The evidence is very uncertain about the effect of argon LPIp on AS-OCT parameters. The trial did not report AS-OCT measurements for the control group. Laser peripheral iridoplasty as a secondary procedure versus medication One RCT assessed the use of argon LPIp as a secondary procedure compared with travoprost 0.004% in 80 participants over 12 months. The primary outcome of disease progression was reported for this method: argon LPIp showed no evidence of effect on mean final cup/disk ratio (MD -0.03, 95% CI -0.11 to 0.05; low-certainty evidence). Argon LPIp showed no evidence of effect for: mean change in IOP (MD -1.20 mmHg, 95% CI -2.87 to 0.47; low-certainty evidence) or mean number of additional medications (MD 0.42, 95% CI 0.23 to 0.61; low-certainty evidence). Further surgical intervention was required by one participant in the intervention group alone, with none in the control group (low-certainty evidence). No serious adverse events were reported, with mild complications consisting of two cases of 'post-laser IOP spike' in the argon LPIp group. Quality of life measures were not assessed. The evidence is very uncertain about the effect of argon LPIp on AS-OCT parameters. The trial did not report AS-OCT measurements for the control group. Adverse events Availability of data were limited for adverse effects. Similar rates were observed in control and intervention groups, where reported. Serious adverse events were rare.
AUTHORS' CONCLUSIONS: After reviewing the outcomes of four RCTs, argon LPIp as an intervention may be no more clinically effective than comparators in the management of people with chronic angle closure. Despite a potential positive impact on anterior chamber morphology, its use in clinical practice in treating people with chronic angle closure is not supported by the results of trials published to date. Given these results, further research into LPIp is unlikely to be worthwhile.
在原发性闭角型青光眼的至少三分之一病例中,激光周边虹膜切开术后仍存在房角粘连,可能需要进一步干预。当激光周边虹膜切开术后仍存在房角关闭时,激光周边虹膜成形术(LPIp)可用于治疗慢性闭角型青光眼。以前的综述发现,与其他干预措施相比,其临床疗效的数据不足。这是对 2008 年首次发表的 Cochrane 综述的更新,并于 2012 年进行了更新。它检查了迄今为止所有的研究,以确定 LPIp 在治疗慢性闭角型青光眼方面是否比其他可用的治疗方法更有效。
评估激光周边虹膜成形术在治疗慢性房角关闭患者中的有效性,与激光周边虹膜切开术、药物治疗或不进一步治疗相比。
我们检索了各种电子数据库。检索日期为 2020 年 12 月 20 日。
我们仅纳入了评估疑似原发性房角关闭(PACS)、确诊原发性房角关闭(PAC)或原发性慢性房角关闭性青光眼(PACG)患者使用 LPIp 的随机对照试验(RCT)。我们对参与者的性别、年龄或种族没有任何限制。评估激光周边虹膜成形术治疗急性房角关闭发作的试验不符合入选条件。
我们使用 Cochrane 预期的标准方法学程序。两位作者独立使用 Cochrane 的“风险偏倚工具”评估研究的风险偏倚。我们从试验中收集了不良反应信息。
我们纳入了四项 RCT,涉及 252 名参与者(276 只眼)。共有三种不同的干预方法和 15 种不同的结局报告,不同的时间点。由于研究设计和评估的结局不同,我们使用叙述性综合方法描述了大部分发现,只有有限数量的结局可以进行 meta 分析。研究特征:参与者为来自英国、新加坡、中国和韩国的门诊成年人,患有 PACS、PAC 或 PACG。所有研究均将氩激光周边虹膜成形术(作为原发性或继发性手术)与另一种干预措施或不进一步治疗进行比较。三项研究为平行组设计,一项为自身对照,随机按眼进行。所有研究均显示出高度偏倚风险的特征。由于评估的干预措施的性质,所有试验都注意到参与者和评估者的双盲都缺乏。
氩激光周边虹膜成形术联合虹膜切开术与虹膜切开术作为原发性手术相比,结果:两项 RCT 评估了氩激光周边虹膜成形术作为原发性手术联合周边虹膜切开术与单纯周边虹膜切开术相比的效果。然而,两项研究均未报告疾病进展这一主要结局的数据。氩激光周边虹膜成形术在以下方面没有显示出效果:3 个月和 12 个月时的最终平均眼内压(IOP)(MD 0.39mmHg,95%置信区间(CI)为-1.07 至 1.85;I = 38%;2 项研究,174 名参与者;低质量证据);12 个月时进一步的手术或激光干预(RR 1.21,95%CI 为 0.66 至 2.21;1 项研究,126 名参与者;低质量证据);或 12 个月时所需的平均附加药物数量(MD 0.10,95%CI 为-0.34 至 0.54;1 项研究,126 名参与者;低质量证据)。在 3 至 12 个月(2 项研究,206 名参与者;低质量证据)评估了并发症,发现并发症轻微且常见,两组之间的水平相当。唯一遇到的严重并发症是一项研究中氩激光周边虹膜成形术组的一例恶性青光眼。未评估生活质量指标。在另一项研究中,研究人员发现氩激光周边虹膜成形术对最终平均前节光学相干断层扫描(AS-OCT)测量值,包括前房深度(MD 0.00mm,95%CI 为-0.10 至 0.10;24 名参与者,48 只眼;极低质量证据),没有显示出效果。
一项 RCT 评估了氩激光周边虹膜成形术作为继发性手术与 3 个月内不进一步治疗相比在 22 名参与者中的效果。未评估疾病进展、所需附加药物、并发症、进一步的手术或激光干预以及生活质量结局。最终最大 IOP 值(MD-1.81mmHg,95%CI-3.11 至-0.51;极低质量证据)仅有非常低的确定性证据,而最终最小 IOP 值(MD-0.31mmHg,95%CI-1.93 至 1.31;极低质量证据)没有证据表明有效果。氩激光周边虹膜成形术对 AS-OCT 参数的影响的证据非常不确定。该试验未报告对照组的 AS-OCT 测量值。
一项 RCT 评估了氩激光周边虹膜成形术作为继发性手术与 travoprost 0.004%在 12 个月内的比较。报告了这种方法的主要结局:房角关闭的平均最终杯盘比(MD-0.03,95%CI-0.11 至 0.05;低质量证据)。氩激光周边虹膜成形术在以下方面没有显示出效果:平均眼压变化(MD-1.20mmHg,95%CI-2.87 至 0.47;低质量证据)或平均附加药物数量(MD0.42,95%CI 0.23 至 0.61;低质量证据)。仅在干预组中有一名参与者需要进一步手术干预,而对照组中没有(低质量证据)。没有报告严重不良事件,仅观察到轻度并发症,包括氩激光周边虹膜成形术组中的两例“激光后眼压升高”(低质量证据)。未报告生活质量指标。该试验未报告对照组的 AS-OCT 测量值,因此对氩激光周边虹膜成形术对 AS-OCT 参数的影响的证据非常不确定。
关于不良反应的数据有限。在报告的情况下,在对照组和干预组中观察到相似的发生率。严重不良事件罕见。
在对四项 RCT 的结果进行审查后,氩激光周边虹膜成形术作为一种干预措施,在治疗慢性房角关闭患者方面可能并不比对照组更有效。尽管对前房形态学有潜在的积极影响,但目前在治疗慢性房角关闭的临床实践中,没有基于该试验结果支持使用 LPIp。考虑到这些结果,进一步研究 LPIp 不太可能是值得的。