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难治性青光眼的睫状体破坏手术

Cyclodestructive procedures for refractory glaucoma.

作者信息

Chen Monica F, Kim Carole H, Coleman Anne L

机构信息

Stein Eye Institute, UCLA, 100 Stein Plaza, Los Angeles, California, USA, 90095.

出版信息

Cochrane Database Syst Rev. 2019 Mar 10;3(3):CD012223. doi: 10.1002/14651858.CD012223.pub2.

Abstract

BACKGROUND

Cyclodestructive procedures are often used in patients with refractory glaucoma who have failed to achieve lower intraocular pressure (IOP) from filtration procedures and maximal medical therapy. Destruction of the ciliary body helps to lower IOP by reducing aqueous humor formation. Of the many types of cyclodestructive procedures, laser cyclophotocoagulation (CPC) has become the most common surgical method for reducing aqueous inflow. Options for CPC are wide-ranging: they can be performed using a neodymium:yttrium-aluminum-garnet (Nd:YAG) or diode laser and laser energy can be delivered by either the contact or non-contact method. Another cyclodestructive procedure is endoscopic cyclophotocoagulation (ECP), which the ophthalmologist can use selectively to target the ciliary epithelium and ablate ciliary body tissue. There is debate regarding which cyclodestructive method is best and how they compare to other glaucoma surgeries.

OBJECTIVES

To assess the relative effectiveness and safety of cyclodestructive procedures compared with other procedures in people with refractory glaucoma of any type and to assess the relative effectiveness and safety of individual cyclodestructive procedures compared with each other.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 9); Ovid MEDLINE; Embase.com; PubMed; LILACS BIREME; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 21 September 2018.

SELECTION CRITERIA

We included randomized controlled trials or quasi-randomized trials in which participants underwent a secondary procedure for refractory glaucoma. We included trials with any laser type, route of administration, and laser settings. The primary comparison was any cyclodestructive procedure versus another glaucoma treatment, and the secondary comparisons were individual cyclodestructive procedures versus another cyclodestructive procedure.

DATA COLLECTION AND ANALYSIS

Two review authors independently reviewed the titles and abstracts from the database searches, and after retrieving the full-text reports of those that were potentially relevant, classified the full-text articles as included or excluded. Two review authors independently extracted data from the included studies and assessed the risk of bias. Discrepancies were resolved by discussion or by consultation with a third review author when necessary.

MAIN RESULTS

We included five trials reporting data for 330 eyes (326 participants). One study to had a low risk of bias for most domains and the other studies had an overall unclear risk of bias. This review includes four different comparisons: 1) ECP versus Ahmed implant, 2) micropulse CPC versus continuous-wave CPC; 3) CPC with a diode versus Nd:YAG laser; and 4) CPC with an Nd:YAG laser emitting 8J versus 4J.No study reported data for our primary outcome, change from baseline in pain severity as reported by the participant or change in number of pain medications.For our primary comparison, we included one trial that compared ECP with the Ahmed implant. At 12-month follow-up, the mean difference (MD) in IOPs between groups was -1.14 mmHg (95% confidence interval (CI) -4.21 to 1.93; 58 participants; low-certainty evidence (LCE)). At 24 months postintervention, we found very LCE suggesting that visual acuity may be better among participants in the ECP group than in the Ahmed implant group (MD -0.24 logMAR, 95% CI -0.52 to 0.04; 54 participants), and the difference in the mean number of glaucoma medications used by participants in each group was unclear (MD -0.50, 95% CI -1.17 to 0.17; 54 participants; very LCE). Reported adverse events in the ECP group (34 participants) were one case each of hypotony, phthisis bulbi, retinal detachment, and choroidal detachment; in the Ahmed implant group (34 participants) there was one case of endophthalmitis, two cases of retinal detachment, and six cases of choroidal detachment.Three types of comparisons from four included studies provided data for our secondary comparisons. In the study that compared micropulse with continuous-wave CPC, median IOP was reported to be similar between the two groups at all time points. At 18 months postintervention, the median number of IOP-lowering medications was reduced from two to one in both groups. One participant in the micropulse and two in the continuous group exhibited worsened visual acuity. One case of prolonged inflammation was seen in the micropulse group (23 participants). Seven cases of prolonged inflammation, five cases of hypotony, and one case of phthisis bulbi were seen in the continuous group (23 participants).Two studies compared CPC using a semiconductor diode versus an Nd:YAG laser. At 12 months postintervention, the MD in IOP was 1.02 mmHg (95% CI -1.49 to 3.53) in one study (LCE). The second study did not report mean IOP beyond three months of follow-up. Neither study reported the mean change in best-corrected visual acuity or number of glaucoma medications. Both studies reported hypotony as an adverse event in three participants in each study.One study compared different energy settings of the same Nd:YAG laser. At 12-month follow-up, visual acuity was unchanged or improved in 21 of 33 participants in the 8J group and 20 of 27 participants in the 4J group (risk ratio 0.86, 95% CI 0.61 to 1.21; very LCE). More participants in the 8J group reduced the number of medications taken compared with the 4J group (RR 1.49, 95% CI 0.76 to 2.91; 50 participants; very low-certainty evidence). The presence of fibrin or hyphema were seen in five participants who received 8J and none who received 4J. There was a severe anterior chamber reaction in 11 of 26 (42%) participants who received 8J of energy and 2 of 21 (10%) participants who received 4J of energy.

AUTHORS' CONCLUSIONS: Evidence from five studies included in this review was inconclusive as to whether cyclodestructive procedures for refractory glaucoma result in better outcomes and fewer complications than other glaucoma treatments, and whether one type of cyclodestructive procedure is better than another. The most commonly reported adverse events across all five studies were hypotony and phthisis bulbi. Large, well-designed randomized controlled trials are needed. Patient-reported outcomes such as pain and quality of life should be considered as primary outcomes or important secondary outcomes of future trials.

摘要

背景

睫状体破坏术常用于药物治疗和滤过性手术均无法有效降低眼压(IOP)的难治性青光眼患者。破坏睫状体可减少房水生成,从而降低眼压。在众多睫状体破坏术中,激光睫状体光凝术(CPC)已成为最常用的减少房水生成的手术方法。CPC的选择范围广泛:可使用钕:钇铝石榴石(Nd:YAG)或二极管激光进行,激光能量可通过接触或非接触方式传递。另一种睫状体破坏术是内窥镜睫状体光凝术(ECP),眼科医生可选择性地针对睫状体上皮并消融睫状体组织。关于哪种睫状体破坏方法最佳以及它们与其他青光眼手术相比如何,目前仍存在争议。

目的

评估睫状体破坏术与其他手术相比,在任何类型的难治性青光眼中的相对有效性和安全性,并评估不同睫状体破坏术之间的相对有效性和安全性。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)(其中包含Cochrane眼科和视力试验注册库)(2018年第9期);Ovid MEDLINE;Embase.com;PubMed;拉丁美洲和加勒比地区卫生科学数据库(LILACS BIREME);ClinicalTrials.gov和世界卫生组织国际临床试验平台(WHO ICTRP)。检索日期为2018年9月21日。

选择标准

我们纳入了随机对照试验或半随机试验,其中参与者接受了难治性青光眼的二次手术。我们纳入了使用任何激光类型、给药途径和激光设置的试验。主要比较是任何睫状体破坏术与另一种青光眼治疗方法,次要比较是不同的睫状体破坏术之间的比较。

数据收集与分析

两位综述作者独立审查了数据库检索中的标题和摘要,并在检索了那些可能相关的全文报告后,将全文文章分类为纳入或排除。两位综述作者独立从纳入研究中提取数据并评估偏倚风险。如有分歧,通过讨论解决,必要时咨询第三位综述作者。

主要结果

我们纳入了五项试验,报告了330只眼(326名参与者)的数据。一项研究在大多数领域的偏倚风险较低,其他研究的总体偏倚风险尚不清楚。本综述包括四种不同的比较:1)ECP与Ahmed植入物;2)微脉冲CPC与连续波CPC;3)二极管CPC与Nd:YAG激光;4)发射8J与4J的Nd:YAG激光CPC。没有研究报告我们的主要结局数据,即参与者报告的疼痛严重程度自基线的变化或止痛药物数量的变化。对于我们的主要比较,我们纳入了一项将ECP与Ahmed植入物进行比较的试验。在12个月的随访中,两组之间眼压的平均差异(MD)为-1.14 mmHg(95%置信区间(CI)-4.21至1.93;58名参与者;低确定性证据(LCE))。干预后24个月,我们发现极低确定性证据表明ECP组参与者的视力可能优于Ahmed植入物组(MD -0.24 logMAR,95% CI -0.52至0.04;54名参与者),且两组参与者使用的青光眼药物平均数量差异不明确(MD -0.50,95% CI -1.17至0.17;54名参与者;极低确定性证据)。ECP组(34名参与者)报告的不良事件包括低眼压、眼球痨、视网膜脱离和脉络膜脱离各1例;Ahmed植入物组(34名参与者)有1例眼内炎、2例视网膜脱离和6例脉络膜脱离。纳入的四项研究中的三种比较类型为我们的次要比较提供了数据。在比较微脉冲与连续波CPC的研究中,两组在所有时间点的眼压中位数均相似。干预后18个月,两组降低眼压药物的中位数均从两种减少至一种。微脉冲组有1名参与者和连续波组有2名参与者的视力恶化。微脉冲组(23名参与者)出现1例炎症延长。连续波组(23名参与者)出现7例炎症延长、5例低眼压和1例眼球痨。两项研究比较了使用半导体二极管与Nd:YAG激光的CPC。干预后12个月,一项研究中眼压的MD为1.02 mmHg(95% CI -1.49至3.53)(低确定性证据)。第二项研究未报告随访三个月后的平均眼压。两项研究均未报告最佳矫正视力的平均变化或青光眼药物数量。两项研究均报告每组有3名参与者出现低眼压这一不良事件。一项研究比较了同一Nd:YAG激光的不同能量设置。在12个月的随访中,8J组33名参与者中的21名和4J组27名参与者中的20名视力未改变或改善(风险比0.86,95% CI 0.61至1.21;极低确定性证据)。与4J组相比,8J组更多参与者减少了用药数量(RR 1.49,95% CI 0.76至2.91;50名参与者;极低确定性证据)。接受8J的5名参与者出现纤维蛋白或前房积血,接受4J的参与者均未出现。接受8J能量的26名(42%)参与者中有11名出现严重前房反应,接受4J能量的21名(10%)参与者中有2名出现严重前房反应。

作者结论

本综述纳入五篇研究的证据,无法确定难治性青光眼的睫状体破坏术与其他青光眼治疗相比是否能带来更好的结局和更少的并发症,也无法确定一种睫状体破坏术是否优于另一种。所有五项研究中最常报告的不良事件是低眼压和眼球痨。需要开展大型、设计良好的随机对照试验。患者报告的结局,如疼痛和生活质量,应被视为未来试验的主要结局或重要次要结局。

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