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色素性青光眼的周边虹膜切开术

Peripheral iridotomy for pigmentary glaucoma.

作者信息

Michelessi Manuele, Lindsley Kristina

机构信息

Ophthalmology, Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmolologia-IRCCS, Via Livenza n 3, Rome, Italy, 00198.

出版信息

Cochrane Database Syst Rev. 2016 Feb 12;2(2):CD005655. doi: 10.1002/14651858.CD005655.pub2.

Abstract

BACKGROUND

Glaucoma is a chronic optic neuropathy characterized by retinal ganglion cell death resulting in damage to the optic nerve head and the retinal nerve fiber layer. Pigment dispersion syndrome is characterized by a structural disturbance in the iris pigment epithelium (the densely pigmented posterior surface of the iris) that leads to dispersion of the pigment and its deposition on various structures within the eye. Pigmentary glaucoma is a specific form of open-angle glaucoma found in patients with pigment dispersion syndrome.Topcial medical therapy is usually the first-line treatment; however, peripheral laser iridotomy has been proposed as an alternate treatment. Peripheral laser iridotomy involves creating an opening in the iris tissue to allow drainage of fluid from the posterior chamber to the anterior chamber and vice versa. Equalizing the pressure within the eye may help to alleviate the friction that leads to pigment dispersion and prevent visual field deterioration. However, the effectiveness of peripheral laser iridotomy in reducing the development or progression of pigmentary glaucoma is unknown.

OBJECTIVES

The objective of this review was to assess the effects of peripheral laser iridotomy compared with other interventions, including medication, trabeculoplasty, and trabeculectomy, or no treatment, for pigment dispersion syndrome and pigmentary glaucoma.

SEARCH METHODS

We searched a number of electronic databases including CENTRAL, MEDLINE and EMBASE and clinical trials websites such as (mRCT) and ClinicalTrials.gov. We last searched the electronic databases on 2 November 2015.

SELECTION CRITERIA

We included randomized controlled trials (RCTs) that had compared peripheral laser iridotomy versus no treatment or other treatments for pigment dispersion syndrome and pigmentary glaucoma.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures for systematic reviews. Two review authors independently screened articles for eligibility, extracted data, and assessed included trials for risk of bias. We did not perform a meta-analysis because of variability in reporting and follow-up intervals for primary and secondary outcomes of interest.

MAIN RESULTS

We included five RCTs (260 eyes of 195 participants) comparing yttrium-aluminum-garnet (YAG) laser iridotomy versus no laser iridotomy. Three trials included participants with pigmentary glaucoma at baseline, and two trials enrolled participants with pigment dispersion syndrome. Only two trials reported the country of enrollment: one - Italy, the other - United Kingdom. Overall, we assessed trials as having high or unclear risk of bias owing to incomplete or missing data and selective outcome reporting.Data on visual fields were available for one of three trials that included participants with pigmentary glaucoma at baseline. At an average follow-up of 28 months, the risk of progression of visual field damage was uncertain when comparing laser iridotomy with no iridotomy (risk ratio (RR) 1.00, 95% confidence interval (95% CI) 0.16 to 6.25; 32 eyes; very low-quality evidence). The two trials that enrolled participants with pigment dispersion syndrome at baseline reported the proportion of participants with onset of glaucomatous visual field changes during the study period. At three-year follow-up, one trial reported that the risk ratio for conversion to glaucoma was 2.72 (95% CI 0.76 to 9.68; 42 eyes; very low-quality evidence). At 10-year follow-up, the other trial reported that no eye showed visual field progression.One trial reported the mean change in intraocular pressure (IOP) in eyes with pigmentary glaucoma: At an average of nine months of follow-up, the mean difference in IOP between groups was 2.69 mmHg less in the laser iridotomy group than in the control group (95% CI -6.05 to 0.67; 14 eyes; very low-quality evidence). This trial also reported the mean change in anterior chamber depth at an average of nine months of follow-up and reported no meaningful differences between groups (mean difference 0.04 mm, 95% CI -0.07 to 0.15; 14 eyes; very low-quality evidence). No other trial reported mean change in anterior chamber depth. Two trials reported greater flattening of iris configuration in the laser iridotomy group than in the control group among eyes with pigmentary glaucoma; however, investigators provided insufficient data for analysis. No trial reported data related to mean visual acuity, aqueous melanin granules, costs, or quality of life outcomes.Two trials assessed the need for additional treatment for control of IOP. One trial that enrolled participants with pigmentary glaucoma reported that more eyes in the laser iridotomy group required additional treatment between six and 23 months of follow-up than eyes in the control group (RR 1.73, 95% CI 1.08 to 2.75; 46 eyes); however, the other trial enrolled participants with pigment dispersion syndrome and indicated that the difference between groups at three-year follow-up was uncertain (RR 0.91, 95% CI 0.38 to 2.17; 105 eyes). We graded the certainty of evidence for this outcome as very low.Two trials reported that no serious adverse events were observed in either group among eyes with pigment dispersion syndrome. Mild adverse events included postoperative inflammation; two participants required cataract surgery (at 18 and 34 months after baseline), and two participants required a repeat iridotomy.

AUTHORS' CONCLUSIONS: We found insufficient evidence of high quality on the effectiveness of peripheral iridotomy for pigmentary glaucoma or pigment dispersion syndrome. Although adverse events associated with peripheral iridotomy may be minimal, the long-term effects on visual function and other patient-important outcomes have not been established. Future research on this topic should focus on outcomes that are important to patients and the optimal timing of treatment in the disease process (eg, pigment dispersion syndrome with normal IOP, pigment dispersion syndrome with established ocular hypertension, pigmentary glaucoma).

摘要

背景

青光眼是一种慢性视神经病变,其特征是视网膜神经节细胞死亡,导致视神经乳头和视网膜神经纤维层受损。色素播散综合征的特征是虹膜色素上皮(虹膜色素密集的后表面)结构紊乱,导致色素播散并沉积在眼内的各种结构上。色素性青光眼是色素播散综合征患者中发现的一种开角型青光眼的特殊形式。局部药物治疗通常是一线治疗;然而,周边激光虹膜切开术已被提议作为一种替代治疗方法。周边激光虹膜切开术是在虹膜组织中制造一个开口,以使房水从后房引流到前房,反之亦然。平衡眼内压力可能有助于减轻导致色素播散的摩擦,并防止视野恶化。然而,周边激光虹膜切开术在减少色素性青光眼发展或进展方面的有效性尚不清楚。

目的

本综述的目的是评估周边激光虹膜切开术与其他干预措施(包括药物治疗、小梁成形术和小梁切除术)或不治疗相比,对色素播散综合征和色素性青光眼的影响。

检索方法

我们检索了多个电子数据库,包括Cochrane中心对照试验注册库(CENTRAL)、医学文献数据库(MEDLINE)和Embase数据库,以及临床试验网站,如国际临床试验注册平台(mRCT)和美国国立医学图书馆临床试验注册网站(ClinicalTrials.gov)。我们最后一次检索电子数据库的时间是2015年11月2日。

选择标准

我们纳入了比较周边激光虹膜切开术与不治疗或其他治疗方法对色素播散综合征和色素性青光眼疗效的随机对照试验(RCT)。

数据收集与分析

我们采用系统评价的标准方法程序。两位综述作者独立筛选文章以确定其是否符合纳入标准,提取数据,并评估纳入试验的偏倚风险。由于所关注主要和次要结局的报告及随访间隔存在差异,我们未进行Meta分析。

主要结果

我们纳入了5项RCT(195名参与者的260只眼),比较钇铝石榴石(YAG)激光虹膜切开术与不进行激光虹膜切开术。三项试验纳入了基线时患有色素性青光眼的参与者,两项试验纳入了患有色素播散综合征的参与者。只有两项试验报告了招募参与者的国家:一项在意大利,另一项在英国。总体而言,由于数据不完整或缺失以及选择性报告结局,我们评估这些试验存在高或不清楚的偏倚风险。在三项基线时纳入患有色素性青光眼参与者的试验中,有一项试验提供了视野数据。平均随访28个月时,比较激光虹膜切开术与不进行虹膜切开术,视野损害进展的风险不确定(风险比(RR)为1.00,95%置信区间(95%CI)为0.16至6.25;32只眼;极低质量证据)。两项基线时纳入患有色素播散综合征参与者的试验报告了研究期间发生青光眼性视野改变的参与者比例。在三年随访时,一项试验报告转为青光眼的风险比为2.72(95%CI为0.76至9.68;42只眼;极低质量证据)。在十年随访时,另一项试验报告没有眼出现视野进展。一项试验报告了色素性青光眼患者眼内压(IOP)的平均变化:平均随访9个月时,激光虹膜切开术组的IOP平均差异比对照组低2.69 mmHg(95%CI为 -6.05至0.67;14只眼;极低质量证据)。该试验还报告了平均随访9个月时前房深度的平均变化,且两组之间无显著差异(平均差异为0.04 mm,95%CI为 -0.07至0.15;14只眼;极低质量证据)。没有其他试验报告前房深度的平均变化。两项试验报告,在患有色素性青光眼的眼中,激光虹膜切开术组的虹膜形态比对照组更扁平;然而,研究者提供的数据不足以进行分析。没有试验报告与平均视力、房水黑色素颗粒、成本或生活质量结局相关的数据。两项试验评估了控制IOP所需额外治疗的必要性。一项纳入色素性青光眼参与者的试验报告,在随访6至23个月期间,激光虹膜切开术组比对照组有更多的眼需要额外治疗(RR为1.73,95%CI为1.08至2.75;46只眼);然而,另一项纳入色素播散综合征参与者的试验表明,在三年随访时两组之间的差异不确定(RR为0.91,95%CI为0.38至2.17;10只眼)。我们将该结局的证据确定性等级评定为极低。两项试验报告,在患有色素播散综合征的眼中,两组均未观察到严重不良事件。轻度不良事件包括术后炎症;两名参与者需要进行白内障手术(基线后18个月和34个月),两名参与者需要重复进行虹膜切开术。

作者结论

我们发现关于周边虹膜切开术对色素性青光眼或色素播散综合征有效性的高质量证据不足。尽管周边虹膜切开术相关的不良事件可能很少,但对视觉功能和其他对患者重要结局的长期影响尚未明确。关于该主题的未来研究应关注对患者重要的结局以及疾病过程中治疗的最佳时机(例如,眼压正常的色素播散综合征、已确诊高眼压的色素播散综合征、色素性青光眼)。

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