Ophthalmology Department, Grampian University Hospitals NHS Trust, Aberdeen, United Kingdom.
Centre for Vision and Vascular Science, Queens University, Belfast, Northern Ireland.
Ophthalmology. 2014 Mar;121(3):649-55. doi: 10.1016/j.ophtha.2013.10.020. Epub 2013 Dec 4.
To determine whether internal limiting membrane (ILM) peeling improves anatomic and functional outcomes of full-thickness macular hole (FTMH) surgery when compared with the no-peeling technique.
Systematic review and individual participant data (IPD) meta-analysis undertaken under the auspices of the Cochrane Eyes and Vision Group. Only randomized controlled trials (RCTs) were included.
Patients with idiopathic stage 2, 3, and 4 FTMH undergoing vitrectomy with or without ILM peeling.
Macular hole surgery, including vitrectomy and gas endotamponade with or without ILM peeling.
Primary outcome was best-corrected distance visual acuity (BCdVA) at 6 months postoperatively. Secondary outcomes were BCdVA at 3 and 12 months; best-corrected near visual acuity (BCnVA) at 3, 6, and 12 months; primary (after a single surgery) and final (after >1 surgery) macular hole closure; need for additional surgical interventions; intraoperative and postoperative complications; patient-reported outcomes (PROs) (EuroQol-5D and Vision Function Questionnaire-25 scores at 6 months); and cost-effectiveness.
Four RCTs were identified and included in the review. All RCTs were included in the meta-analysis; IPD were obtained from 3 of the 4 RCTs. No evidence of a difference in BCdVA at 6 months was detected (mean difference, -0.04; 95% confidence interval [CI], -0.12 to 0.03; P=0.27); however, there was evidence of a difference in BCdVA at 3 months favoring ILM peeling (mean difference, -0.09; 95% CI, -0.17 to-0.02; P=0.02). There was evidence of an effect favoring ILM peeling with regard to primary (odds ratio [OR], 9.27; 95% CI, 4.98-17.24; P<0.00001) and final macular hole closure (OR, 3.99; 95% CI, 1.63-9.75; P=0.02) and less requirement for additional surgery (OR, 0.11; 95% CI, 0.05-0.23; P<0.00001), with no evidence of a difference between groups with regard to intraoperative or postoperative complications or PROs. The ILM peeling was found to be highly cost-effective.
Available evidence supports ILM peeling as the treatment of choice for patients with idiopathic stage 2, 3, and 4 FTMH.
比较全层黄斑裂孔（FTMH）手术中内界膜（ILM）剥除与不剥除技术对解剖和功能结果的影响。
在 Cochrane 眼与视觉组的支持下进行的系统评价和个体参与者数据（IPD）荟萃分析。仅纳入随机对照试验（RCT）。
接受玻璃体切除术联合或不联合 ILM 剥除术治疗特发性 2 期、3 期和 4 期 FTMH 的患者。
黄斑裂孔手术，包括玻璃体切除术和气体内填充联合或不联合 ILM 剥除术。
主要结局为术后 6 个月最佳矫正远视力（BCdVA）。次要结局为术后 3 个月和 12 个月的 BCdVA；术后 3 个月、6 个月和 12 个月的最佳矫正近视力（BCnVA）；原发性（单次手术后）和最终（>1 次手术后）黄斑裂孔闭合；需要额外手术干预；术中及术后并发症；患者报告的结局（EuroQol-5D 和视觉功能问卷-25 评分，术后 6 个月）；以及成本效益。
确定了 4 项 RCT 并纳入了综述。所有 RCT 均纳入荟萃分析；从 4 项 RCT 中的 3 项获得了 IPD。未发现 6 个月时 BCdVA 存在差异（平均差异，-0.04；95%置信区间[CI]，-0.12 至 0.03；P=0.27）；然而，有证据表明 ILM 剥除术在 3 个月时对 BCdVA 有利（平均差异，-0.09；95%CI，-0.17 至-0.02；P=0.02）。有证据表明 ILM 剥除术在原发性（优势比[OR]，9.27；95%CI，4.98-17.24；P<0.00001）和最终黄斑裂孔闭合（OR，3.99；95%CI，1.63-9.75；P=0.02）方面具有优势，且需要额外手术的可能性较低（OR，0.11；95%CI，0.05-0.23；P<0.00001），两组在术中或术后并发症或患者报告结局方面无差异。ILM 剥除术被认为具有很高的成本效益。
现有证据支持 ILM 剥除术作为特发性 2 期、3 期和 4 期 FTMH 患者的治疗选择。
