BACKGROUND To compare the anatomical and functional outcomes of the inverted internal limiting membrane (ILM) flap technique and the complete ILM removal in the treatment of large stage 4 macular hole (MH) > 400 μm and to evaluate reconstructive anatomical changes in foveal microstructure using spectral-domain optical coherence tomography. METHODS This is a retrospective, consecutive, nonrandomized comparative study of patients affected by idiopathic, myopic or traumatic stage 4 MH (minimum diameter > 400 μm) treated with 25-gauge pars-plana vitrectomy with either complete ILM peeling (n = 23, Group 1) or inverted ILM flap technique (n = 23, Group 2), between August 2016 and August 2018. Main outcomes measured were the MH closure rate assessed by spectral-domain optical coherence tomography and the best-corrected visual acuity (BCVA) at six months. Foveal microstructure reconstructive changes were evaluated using SD-OCT to determine predictive factors of postoperative BCVA. RESULTS Closure of MH was achieved in 16/23 cases of Group 1 (70%) and in 22/23 cases of the Group 2 (96%). Surgical failure was reported in 6 cases of Group 1 and 1 case of Group 2. The MH closure rate was significantly higher with the inverted ILM flap technique (P-value = 0.02). Average BCVA (LogMAR) changed from 1.04 ± 0.32 to 0.70 ± 0.31 in Group 1 and from 0.98 ± 0.22 to 0.45 ± 0.25 in Group 2 (P-value = 0.005) at 6 months. Improvement in BCVA (> 0.3 LogMAR units) was statistically higher in the Group 2 (P-value = 0.03). Restoration of foveal microstructure was significantly higher in the Group 2 at 6 months (52% vs 9%, P-value < 0.01). In Group 2, the integrity of the external limiting membrane at 3 months postoperatively was the only significant feature correlated with postoperative BCVA at 6 months (r = 0.562; P-Value = 0.01, forward stepwise regression analysis). CONCLUSION Inverted ILM flap technique is more effective than the classic ILM peeling for the closure of large stage 4 MHs > 400 μm, improving both anatomical and functional outcomes. Early recovery of the external limiting membrane at 3 months is a positive predictive value of postoperative BCVA 6 months after inverted ILM flap technique.

中文翻译：

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大黄斑裂孔内倒膜内翻瓣技术与内膜完全脱膜的比较研究。

背景为了比较内翻限膜（ILM）皮瓣技术的解剖学和功能结局以及在治疗大于400μm的第4阶段大黄斑裂孔（MH）中完全去除ILM的情况，并使用光谱技术评估中心凹显微结构的重建性解剖变化域光学相干断层扫描。方法这是一项回顾性，连续，非随机的比较研究，研究对象是患有25口径pars-plana玻璃体切除术或完全ILM剥脱术（n = 23，组）的特发性，近视或创伤期4 MH（最小直径> 400μm）患者1）或反向ILM瓣技术（n = 23，第2组），时间为2016年8月至2018年8月。测得的主要结局是通过光谱域光学相干断层扫描评估的MH闭合率和六个月时的最佳矫正视敏度（BCVA）。使用SD-OCT评估中央凹微结构的重建变化，以确定术后BCVA的预测因素。结果第一组的16/23例（70％）和第二组的22/23例（96％）实现了MH闭合。在第1组的6例和第2组的1例中报告了手术失败。采用倒置ILM皮瓣技术，MH闭合率显着更高（P值= 0.02）。第6组的平均BCVA（LogMAR）从第1组的1.04±0.32变为0.70±0.31，从第2组的0.98±0.22变为0.45±0.25（P值= 0.005）。第2组中BCVA的改善（> 0.3 LogMAR单位）在统计学上更高（P值= 0.03）。在第2组，在6个月时，中心凹微结构的恢复显着更高（52％对9％，P值<0.01）。在第2组中，术后3个月时外部限制膜的完整性是与6个月时术后BCVA相关的唯一显着特征（r = 0.562； P值= 0.01，正向逐步回归分析）。结论倒置ILM皮瓣技术比传统的ILM剥皮术更能有效封闭4 MHs> 400μm的较大阶段，改善解剖和功能结果。倒置ILM皮瓣技术术后6个月，外部限制膜的早期恢复在3个月时具有阳性预测价值。术后3个月，外部限制膜的完整性是与6个月术后BCVA相关的唯一显着特征（r = 0.562； P值= 0.01，正向逐步回归分析）。结论倒置ILM皮瓣技术比传统的ILM剥皮术更能有效封闭4 MHs> 400μm的较大阶段，改善解剖和功能结果。倒置ILM皮瓣技术术后6个月，外部限制膜的早期恢复在3个月时具有阳性预测价值。术后3个月，外部限制膜的完整性是与6个月术后BCVA相关的唯一显着特征（r = 0.562； P值= 0.01，正向逐步回归分析）。结论倒置ILM皮瓣技术比传统的ILM剥皮术更能有效封闭4 MHs> 400μm的较大阶段，改善解剖和功能结果。倒置ILM皮瓣技术术后6个月，外部限制膜的早期恢复在3个月时具有阳性预测价值。结论倒置ILM皮瓣技术比传统的ILM剥皮术更能有效封闭4 MHs> 400μm的较大阶段，改善解剖和功能结果。倒置ILM皮瓣技术术后6个月，外部限制膜的早期恢复在3个月时具有阳性预测价值。结论倒置ILM皮瓣技术比传统的ILM剥皮术更能有效封闭4 MHs> 400μm的较大阶段，改善解剖和功能结果。倒置ILM皮瓣技术术后6个月，外部限制膜的早期恢复在3个月时具有阳性预测价值。