Znaor Ljubo, Medic Aleksej, Binder Susanne, Vucinovic Ana, Marin Lovric Josipa, Puljak Livia
Department of Ophthalmology, University Hospital Centre Split, Spinciceva 1, Split, Croatia, 21000.
Cochrane Database Syst Rev. 2019 Mar 8;3(3):CD009562. doi: 10.1002/14651858.CD009562.pub2.
Rhegmatogenous retinal detachment (RRD) is a separation of neurosensory retina from the underlying retinal pigment epithelium. It is caused by retinal tears, which let fluid pass from the vitreous cavity to the subretinal space. Pars plana vitrectomy (PPV), scleral buckling surgery and pneumatic retinopexy are three accepted management strategies whose efficacy remains controversial. Pneumatic retinopexy is considered in a separate Cochrane Review.
The primary objective of this review was to assess the efficacy of PPV versus scleral buckling for the treatment of simple RRD (primary RRD of any extension with up to two clock hours large break(s) regardless of their anterior/posterior localisation) in people with (phakia) or without (aphakia) a natural lens in the eye, or with an artificial lens (pseudophakia). A secondary objective was to assess any data on economic and quality-of-life measures.
We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; MEDLINE; Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 5 December 2018.
We included randomised controlled trials (RCTs) comparing PPV versus scleral buckling surgery with at least three months of follow-up.
We used standard Cochrane methodology. Two review authors independently extracted the data and study characteristics from the studies identified as eligible after initial screening. We considered the following outcomes: primary retinal reattachment, postoperative visual acuity, final anatomical success, recurrence of retinal detachment, number of interventions needed to achieve final anatomical success, quality of life and adverse effects. We assessed the certainty of evidence using GRADE.
This review included 10 RCTs (1307 eyes of 1307 participants) from Europe, India, Iran, Japan and Mexico, which compared PPV and scleral buckling for RRD repair. Two of these 10 studies compared PPV combined with scleral buckling with scleral buckling alone (54 participants). All studies were high or unclear risk of bias on at least one domain. Five studies were funded by non-commercial sources, while the other five studies did not report source of funding.There was little or no difference in the proportion of participants who achieved retinal reattachment at least 3 months after the operation in the PPV group compared to those in the scleral buckling group (risk ratio (RR) 1.07, 95% confidence intervals (CI) 0.98 to 1.16; 9 RCTs, 1261 participants, low-certainty evidence). Approximately 67 in every 100 people treated with scleral buckling had retinal reattachment by 3 to 12 months. Treatment with PPV may result in 4 more people with retinal reattachment in every 100 people treated (95% confidence interval (CI) 2 fewer to 11 more).There was no evidence of any important difference in postoperative visual acuity between participants in the PPV group compared to those in the scleral buckling group (mean difference (MD) 0.00 logMAR, 95% CI -0.09 to 0.10, 6 RCTs, 1138 participants, low-certainty evidence).There was little or no difference in final anatomical success between participants in the PPV group and scleral buckling group (RR 1.01, 95% CI 0.99 to 1.04, 9 RCTs, 1235 participants, low-certainty evidence). There were 94 out of 100 people treated with control (scleral buckling) that achieved final anatomical success compared to 96 out of 100 in the PPV group.Retinal redetachment was reported in fewer participants in the PPV group compared to the scleral buckling group (RR 0.75 (95% CI 0.59 to 0.96, 9 RCTs, 1320 participants, low-certainty evidence). Approximately 28 in every 100 people treated with scleral buckling had retinal detachment by 3 to 36 months. Treatment with PPV may result in seven fewer people with retinal detachment in every 100 people treated (95% CI 1 to 11 fewer).Participants treated with PPV on average needed fewer interventions to achieve final anatomical success but the difference was small and data were skewed (MD -0.20, 95% CI -0.34 to -0.06, 2 RCTs, 682 participants, very low-certainty evidence).Very low-certainty evidence on quality of life suggested that more people in the PPV group were "satisfied with vision" compared with the scleral buckling group (RR 6.22, 95% CI 0.88 to 44.09, 1 RCT, 32 participants).All included studies reported adverse effects, however, it was not always clear whether they were reported as number of participants or number of adverse effects. Cataract development or progression was more prevalent in the PPV group (RR 1.71, 95% CI 1.45 to 2.01), choroidal detachment was more prevalent in the scleral buckling group (RR 0.19, 95% CI 0.06 to 0.65) and new/iatrogenic breaks were observed only in the PPV group (RR 8.21, 95% CI 1.91 to 35.21). Estimates of the relative frequency of other adverse effects, including postoperative proliferative vitreoretinopathy, postoperative increase in intraocular pressure, development of cystoid macular oedema, macular pucker and strabismus were imprecise. Evidence for adverse effects was low-certainty evidence.
AUTHORS' CONCLUSIONS: Low- or very low-certainty evidence indicates that there may be little or no difference between PPV and scleral buckling in terms of primary success rate, visual acuity gain and final anatomical success in treating primary RRD. Low-certainty evidence suggests that there may be less retinal redetachment in the PPV group. Some adverse events appeared to be more common in the PPV group, such as cataract progression and new iatrogenic breaks, whereas others were more commonly seen in the scleral buckling group such as choroidal detachment.
孔源性视网膜脱离(RRD)是神经感觉视网膜与下方视网膜色素上皮的分离。它由视网膜裂孔引起,使液体从玻璃体腔进入视网膜下间隙。玻璃体切除术(PPV)、巩膜扣带术和气体视网膜固定术是三种公认的治疗策略,但其疗效仍存在争议。气体视网膜固定术在另一篇Cochrane系统评价中进行了探讨。
本系统评价的主要目的是评估PPV与巩膜扣带术治疗单纯RRD(任何范围的原发性RRD,伴有至多两个钟点的大裂孔,无论其前后位置)的疗效,患者眼内有(晶状体眼)或无(无晶状体眼)天然晶状体,或有人工晶状体(人工晶状体眼)。次要目的是评估有关经济和生活质量指标的任何数据。
我们检索了CENTRAL(其中包含Cochrane眼科和视力试验注册库)、MEDLINE、Embase、LILACS、ISRCTN注册库、ClinicalTrials.gov和世界卫生组织国际临床试验平台。检索日期为2018年12月5日。
我们纳入了比较PPV与巩膜扣带术且随访至少3个月的随机对照试验(RCT)。
我们采用标准的Cochrane方法。两位综述作者独立从初步筛选后确定为合格的研究中提取数据和研究特征。我们考虑了以下结局:原发性视网膜复位、术后视力、最终解剖学成功、视网膜脱离复发、实现最终解剖学成功所需的干预次数、生活质量和不良反应。我们使用GRADE评估证据的确定性。
本系统评价纳入了来自欧洲、印度、伊朗、日本和墨西哥的10项RCT(1307名参与者的1307只眼),这些研究比较了PPV和巩膜扣带术治疗RRD的效果。这10项研究中有两项比较了PPV联合巩膜扣带术与单纯巩膜扣带术(54名参与者)。所有研究在至少一个领域的偏倚风险为高或不明确。5项研究由非商业来源资助,而其他5项研究未报告资金来源。与巩膜扣带术组相比,PPV组术后至少3个月实现视网膜复位的参与者比例几乎没有差异(风险比(RR)1.07,95%置信区间(CI)0.98至1.16;9项RCT,1261名参与者,低确定性证据)。每100名接受巩膜扣带术治疗的人中,约67人在3至12个月时实现视网膜复位。每100名接受PPV治疗的人中,可能会多4人实现视网膜复位(95%置信区间(CI)少2人至多11人)。与巩膜扣带术组相比,PPV组参与者的术后视力没有任何重要差异的证据(平均差(MD)0.00 logMAR,95% CI -0.09至0.10,6项RCT,1138名参与者,低确定性证据)。PPV组和巩膜扣带术组参与者的最终解剖学成功几乎没有差异(RR 1.01,95% CI 0.99至1.04,9项RCT,1235名参与者,低确定性证据)。每100名接受对照(巩膜扣带术)治疗的人中,94人实现了最终解剖学成功,而PPV组为每100人中96人。与巩膜扣带术组相比,PPV组报告视网膜再次脱离的参与者较少(RR 0.75(95% CI 0.59至0.96,9项RCT,1320名参与者,低确定性证据)。每100名接受巩膜扣带术治疗的人中,约28人在3至36个月时发生视网膜脱离。每100名接受PPV治疗的人中,可能会少7人发生视网膜脱离(95% CI少至1人至多11人)。接受PPV治疗的参与者平均需要更少的干预来实现最终解剖学成功,但差异很小且数据存在偏倚(MD -0.20,95% CI -0.34至-0.06,2项RCT,682名参与者,极低确定性证据)。关于生活质量的极低确定性证据表明,与巩膜扣带术组相比,PPV组中更多人“对视力满意”(RR 6.22,95% CI 0.88至44.09,1项RCT,32名参与者)。所有纳入研究均报告了不良反应,然而,并不总是清楚它们是按参与者数量还是不良反应数量报告的。白内障发展或进展在PPV组中更常见(RR 1.71,95% CI 1.45至2.01),脉络膜脱离在巩膜扣带术组中更常见(RR 0.19,95% CI 0.06至0.65),仅在PPV组中观察到新的/医源性裂孔(RR 8.21,95% CI 1.91至35.21)。包括术后增生性玻璃体视网膜病变、术后眼压升高、黄斑囊样水肿形成、黄斑皱襞和斜视在内的其他不良反应的相对频率估计不精确。不良反应的证据为低确定性证据。
低或极低确定性证据表明,在治疗原发性RRD方面,PPV与巩膜扣带术在原发性成功率、视力提高和最终解剖学成功方面可能几乎没有差异。低确定性证据表明,PPV组的视网膜再次脱离可能较少。一些不良事件在PPV组似乎更常见,如白内障进展和新的医源性裂孔,而其他一些不良事件在巩膜扣带术组更常见,如脉络膜脱离。