UCL Institute of Ophthalmology, London, UK.
Western Eye Hospital, Imperial College Healthcare NHS Trust, London, UK.
Cochrane Database Syst Rev. 2021 Mar 24;3(3):CD013297. doi: 10.1002/14651858.CD013297.pub2.
Epiretinal membrane is an abnormal sheet of avascular fibrocellular tissue that develops on the inner surface of the retina. Epiretinal membrane can cause impairment of sight as a consequence of progressive distortion of retinal architecture.
To determine the effects of surgery compared to no intervention for epiretinal membrane.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, ISRCTN registry, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). There were no restrictions to language or year of publication. The databases were last searched on 20 May 2020.
We included randomised controlled trials (RCTs) assessing surgical removal of idiopathic epiretinal membrane compared to placebo, no treatment or sham treatment. Paired or within-person studies were included, as well as those where both eyes of a single participant were treated.
We used standard methods expected by Cochrane, and assessed certainty using the GRADE system. We considered the following five outcome measures: mean change in best corrected visual acuity (BCVA) in the study eye between baseline (before randomisation), 6 months and 12 months later; proportion of people with a gain of 0.3 logMAR or more of visual acuity in the study eye as measured by a logMAR chart at a starting distance of 4 m at 6 months and 12 months after randomisation; proportion of people with a loss of 0.3 logMAR or more of visual acuity in the study eye as measured by a logMAR chart at a starting distance of 4 m at 6 months and 12 months after randomisation; mean quality of life score at 6 months and 12 months following surgery, measured using a validated questionnaire; and any harm identified during follow-up.
We included one study in the review. This was a RCT including 53 eyes of 53 participants with mild symptomatic epiretinal membrane and BCVA of 65 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Participants were randomly allocated to immediate surgery or to watchful waiting with deferred surgery if indicated by evidence of disease progression. The study was limited by imprecision owing to the small number of participants and was at some risk of bias owing to inconsistencies in the time points for outcome assessment and in the management of lens opacity. At 12 months, the visual acuity in the immediate surgery group was higher by a mean of 2.1 (95% confidence interval (CI) -2.0 to 6.2 ETDRS letters; 53 participants; low-certainty evidence) than the watchful waiting/deferred surgery group. The evidence of the effect of immediate surgery on gains of 0.3 logMAR or more of visual acuity is very uncertain (risk ratio (RR) 0.55, 95% CI 0.06 to 4.93; 53 participants; very low-certainty evidence). At 12 months, no participant in either group sustained a loss of 0.3 logMAR or more of visual acuity (53 participants; low-certainty evidence). The included study did not measure quality of life. At 12 months, no serious adverse event was identified in any participant. One participant developed chronic minimal cystoid macular oedema following immediate surgery (53 participants; low-certainty evidence).
AUTHORS' CONCLUSIONS: We found no RCT that directly investigated the effect of surgery compared to no intervention. For severe disabling epiretinal membrane, the lack of a RCT comparing surgery to no intervention may reflect evidence from non-randomised studies in favour of surgery; a RCT may be considered unnecessary and ethically unacceptable because a superior effect of surgery is widely accepted. For mild symptomatic epiretinal membrane, however, the value of surgery is uncertain. Low-certainty evidence from this review suggests that watchful waiting or deferred surgery may offer outcomes as favourable as immediate surgery. However, this finding needs to be confirmed in further RCTs with appropriate statistical power, masking of treatment allocation, consistent management of cataract, and measurement of outcomes including patient-reported quality of life over a more extended time frame.
视网膜内细胞层是一种异常的无血管纤维细胞组织，在视网膜内表面形成。视网膜内细胞层可能会导致视网膜结构的逐渐变形，从而导致视力受损。
确定手术与不干预相比治疗视网膜内细胞层的效果。
我们检索了 Cochrane 中心对照试验注册库（CENTRAL）、MEDLINE Ovid、Embase Ovid、ISRCTN 注册库、美国国立卫生研究院正在进行的临床试验登记处（ClinicalTrials.gov）和世界卫生组织（WHO）国际临床试验注册平台（ICTRP）。我们对语言或出版年份没有限制。数据库最后一次检索时间是 2020 年 5 月 20 日。
我们纳入了评估特发性视网膜内细胞层手术与安慰剂、不治疗或假手术相比的随机对照试验（RCT）。包括配对或个体内研究，以及对单个参与者的双眼进行治疗的研究。
我们使用了 Cochrane 预期的标准方法，并使用 GRADE 系统评估了确定性。我们考虑了以下五个结局指标：研究眼在基线（随机分组前）、6 个月和 12 个月后最佳矫正视力（BCVA）的平均变化；研究眼在 4 米起始距离处使用 logMAR 图表在 6 个月和 12 个月后视力提高 0.3 logMAR 或以上的人数比例；研究眼在 4 米起始距离处使用 logMAR 图表在 6 个月和 12 个月后视力下降 0.3 logMAR 或以上的人数比例；在手术后 6 个月和 12 个月使用经过验证的问卷测量的生活质量评分的平均得分；以及随访期间发现的任何伤害。
我们纳入了一项研究。这是一项 RCT，纳入了 53 名参与者的 53 只眼，这些参与者患有轻度症状性视网膜内细胞层，BCVA 为 65 个或更多的早期糖尿病视网膜病变研究（ETDRS）字母。参与者被随机分配到立即手术组或观察等待组，如果有疾病进展的证据，则推迟手术。该研究受到参与者数量少的限制，并且由于结局评估和白内障管理的时间点不一致以及治疗分配不设盲，存在一定的偏倚风险。在 12 个月时，立即手术组的视力比观察等待/延迟手术组高平均 2.1（95%置信区间（CI）-2.0 至 6.2 ETDRS 字母；53 名参与者；低确定性证据）。立即手术对提高 0.3 logMAR 或以上视力的效果的证据非常不确定（风险比（RR）0.55，95%CI 0.06 至 4.93；53 名参与者；极低确定性证据）。在 12 个月时，两组均无参与者出现 0.3 logMAR 或以上的视力损失（53 名参与者；低确定性证据）。纳入的研究没有测量生活质量。在 12 个月时，任何参与者均未发生严重不良事件。一名参与者在立即手术后出现慢性微小囊样黄斑水肿（53 名参与者；低确定性证据）。
我们没有发现直接比较手术与不干预的 RCT。对于严重的致残性视网膜内细胞层，缺乏比较手术与不干预的 RCT 可能反映了来自非随机研究的证据支持手术；由于广泛接受手术效果较好，因此可能认为进行 RCT 是不必要的，而且在伦理上不可接受。然而，对于轻度症状性视网膜内细胞层，手术的价值是不确定的。本综述的低确定性证据表明，观察等待或延迟手术可能提供与立即手术相似的结果。然而，这一发现需要在进一步的 RCT 中得到证实，这些 RCT 应具有适当的统计效力、治疗分配设盲、一致的白内障管理以及在更长的时间框架内测量包括患者报告的生活质量在内的结局。
