Virgili Gianni, Michelessi Manuele, Parodi Maurizio B, Bacherini Daniela, Evans Jennifer R
Department of Translational Surgery and Medicine, Eye Clinic, University of Florence, Largo Brambilla, 3, Florence, Italy, 50134.
Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD006537. doi: 10.1002/14651858.CD006537.pub3.
Drusen are amorphous yellowish deposits beneath the sensory retina. People with drusen, particularly large drusen, are at higher risk of developing age-related macular degeneration (AMD). The most common complication in AMD is choroidal neovascularisation (CNV), the growth of new blood vessels in the centre of the macula. The risk of CNV is higher among people who are already affected by CNV in one eye.It has been observed clinically that laser photocoagulation of drusen leads to their disappearance and may prevent the occurrence of advanced disease (CNV or geographic atrophy) associated with visual loss.
To examine the effectiveness and adverse effects of laser photocoagulation of drusen in AMD.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to August 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 August 2015.
Randomised controlled trials (RCTs) of laser treatment of drusen in AMD in which laser treatment had been compared with no intervention or sham treatment. Two types of trials were included. Some trials studied one eye of each participant (unilateral studies); other studies recruited participants with bilateral drusen and randomised one eye to photocoagulation or control and the fellow eye to the other group.
Two review authors independently selected studies and extracted data. We pooled data from unilateral and bilateral studies using a random-effects model. For the bilateral studies, we estimated the within-person correlation coefficient from one study and assumed it was valid for the others.
The update of this review found two additional studies, totaling 11 studies that randomised 2159 participants (3580 eyes) and followed them up to two years, of which six studies (1454 participants) included people with one eye randomised to treatment and one to control. Studies were conducted in Australia, Europe and North America.Overall, the risk of bias in the included studies was low, particularly for the larger studies and for the primary outcome development of CNV. Photocoagulation did not reduce the development of CNV at two years' follow-up (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.79 to 1.46, 11 studies, 2159 participants (3580 eyes), high quality evidence). This estimate means that, given an overall occurrence of CNV of 8.3% in the control group, we estimated an absolute risk reduction by no more than 1.4% in the laser group, according to the lower CI limit. Only two studies investigated the effect on the development of geographic atrophy and could not show a difference, but estimates were imprecise (OR 1.30, 95% CI 0.38 to 4.51, two studies, 148 participants (148 eyes), low quality evidence).Among secondary outcomes, photocoagulation led to drusen reduction (OR 9.16, 95% CI 6.28 to 13.4, three studies, 570 participants (944 eyes), high quality evidence) but was not shown to limit loss of 3 or more lines of visual acuity (OR 0.99, 95% CI 0.81 to 1.22, nine studies, 2002 participants (2386 eyes), moderate quality evidence).In a subgroup analysis, no difference could be shown for conventional visible (eight studies) versus subthreshold invisible (four studies) photocoagulation for the primary outcomes (P value = 0.29). The effect in the subthreshold group did not suggest a relevant benefit (OR 1.27, 95% CI 0.82 to 1.98). No study used micropulse subthreshold photocoagulation.No other adverse effects (apart from development of CNV, geographic atrophy or visual loss) were reported.
AUTHORS' CONCLUSIONS: The trials included in this review confirm the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, treatment does not result in a reduction in the risk of developing CNV, and was not shown to limit the occurrence of geographic atrophy or visual acuity loss.Ongoing studies are being conducted to assess whether the use of extremely short laser pulses (i.e. nanosecond laser treatment) cannot only lead to drusen regression but also prevent neovascular AMD.
玻璃疣是位于视网膜感觉层下方的无定形淡黄色沉积物。患有玻璃疣,尤其是大玻璃疣的人,发生年龄相关性黄斑变性(AMD)的风险更高。AMD最常见的并发症是脉络膜新生血管形成(CNV),即黄斑中心出现新血管生长。一只眼睛已出现CNV的人发生CNV的风险更高。临床观察发现,对玻璃疣进行激光光凝可使其消失,并可能预防与视力丧失相关的晚期疾病(CNV或地图样萎缩)的发生。
研究对AMD患者的玻璃疣进行激光光凝的有效性和不良反应。
我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(2015年第7期)、Ovid MEDLINE、Ovid MEDLINE在研及其他未索引引文、Ovid MEDLINE每日更新、Ovid OLDMEDLINE(1946年1月至2015年8月)、EMBASE(1980年1月至2015年8月)、拉丁美洲和加勒比卫生科学文献数据库(LILACS)(1982年1月至2015年8月)、ISRCTN注册库(www.isrctn.com/editAdvancedSearch)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。我们在电子检索试验时未设置任何日期或语言限制。我们最近一次检索电子数据库的时间是2015年8月3日。
将激光治疗AMD玻璃疣的随机对照试验(RCT)与未干预或假治疗进行比较。纳入了两种类型的试验。一些试验研究了每位参与者的一只眼睛(单侧研究);其他研究招募了双侧有玻璃疣的参与者,将一只眼睛随机分配接受光凝或对照治疗,另一只眼睛分配到另一组。
两名综述作者独立选择研究并提取数据。我们使用随机效应模型汇总单侧和双侧研究的数据。对于双侧研究,我们从一项研究中估计个体内相关系数,并假设其对其他研究也有效。
本次综述的更新发现了另外两项研究,共有11项研究将2159名参与者(3580只眼)随机分组,并随访了两年,其中六项研究(1454名参与者)将一只眼睛随机分配接受治疗,另一只眼睛作为对照。研究在澳大利亚、欧洲和北美进行。总体而言,纳入研究的偏倚风险较低,尤其是对于较大规模的研究以及CNV发生这一主要结局。在两年的随访中,光凝并未降低CNV的发生风险(优势比(OR)为1.07,95%置信区间(CI)为0.79至1.46,11项研究,2159名参与者(3580只眼),高质量证据)。这一估计意味着,根据较低的CI下限,鉴于对照组中CNV的总体发生率为8.3%,我们估计激光组的绝对风险降低不超过1.4%。仅有两项研究调查了对地图样萎缩发生的影响,未显示出差异,但估计值不精确(OR为1.30,95%CI为0.38至4.51,两项研究,148名参与者(148只眼),低质量证据)。在次要结局中,光凝导致玻璃疣减少(OR为9.16,95%CI为6.28至13.4,三项研究,570名参与者(944只眼),高质量证据),但未显示出能限制视力下降3行或更多(OR为0.99,95%CI为0.81至1.22,九项研究,2002名参与者(2386只眼),中等质量证据)。在亚组分析中,对于主要结局,传统可见光凝(八项研究)与阈下不可见光凝(四项研究)之间未显示出差异(P值 = 0.29)。阈下组的效果未显示出相关益处(OR为1.27,95%CI为0.82至1.98)。没有研究使用微脉冲阈下光凝。未报告其他不良反应(除了CNV、地图样萎缩或视力丧失的发生)。
本综述纳入的试验证实了临床观察结果,即对玻璃疣进行激光光凝可使其消失。然而,治疗并未降低发生CNV的风险,也未显示出能限制地图样萎缩或视力丧失的发生。正在进行研究以评估使用极短激光脉冲(即纳秒激光治疗)是否不仅能使玻璃疣消退,还能预防新生血管性AMD。