BACKGROUND The study was proposed to determine whether nerve growth factor (NGF) combined with an internal limiting membrane (ILM) insertion was effective in the large idiopathic full-thickness macular hole (iFTMH) therapy. METHODS A subset of 18 eyes (July 2015-October 2017) diagnosed as the large iFTMH were enrolled in this study. The subjects were treated using ILM insertion technique alone (ILM group) or ILM combined with NGF injection (NGF group) and the follow-up period was 6 months. Macular hole closure rates, best-corrected visual acuity (BCVA, improvements using ETDRS), and optical coherence tomography (OCT) findings were analyzed at 1st, 3rd, and 6th months postoperatively. RESULTS We found that macular holes in both groups fully closed. In comparison to ILM insertion group, the NGF group had better BCVA at the 3rd month (48.00 ± 2.392 vs 58.22 ± 2.957, 95% confidence interval (CI): 2.159 to 18.29). The mean external limiting membrane (ELM, 422.2 ± 96 vs 674.9 ± 103.6, 95% CI: - 47.26 to 552.8) and ellipsoid zone (EZ, 496.7 ± 101.6 vs 766.7 ± 111.8, 95% CI: - 50.29 to 590.4) defects were significantly smaller in the NGF group at the 6th month in the follow-up examination. Complete recovery of ELM and EZ was observed in the NGF group in one eye of a patient and two eyes of two patients, respectively. In comparison, one eye's ELM and another eye's EZ were completely recovered in the ILM insertion group. CONCLUSION Our results indicated that ILM insertion with NGF injection might be an effective technique for the initial surgical treatment of eyes with large MHs. The proposed approach yielded better recovery of the photoreceptor layers and consequently might have superior postoperative visual acuity. TRIAL REGISTRATION chiCTR1900021711. Retrospectively registered 5 March 2019.

中文翻译：

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内部限制膜插入技术结合神经生长因子注射治疗大黄斑裂孔。

背景技术提出这项研究以确定神经生长因子（NGF）结合内部限制膜（ILM）插入在大型特发性全层黄斑裂孔（iFTMH）治疗中是否有效。方法本研究纳入了被诊断为大型iFTMH的18只眼（2015年7月至2017年10月）的一部分。使用单独的ILM插入技术（ILM组）或ILM联合NGF注射（NGF组）对受试者进行治疗，随访期为6个月。在术后第1、3和6个月对黄斑裂孔闭合率，最佳矫正视力（BCVA，使用ETDRS进行的改善）和光学相干断层扫描（OCT）结果进行了分析。结果我们发现两组黄斑裂孔完全闭合。与ILM插入组相比，NGF组在第3个月的BCVA更好（48.00±2）。392对58.22±2.957，95％置信区间（CI）：2.159至18.29）。平均外部极限膜（ELM，422.2±96 vs 674.9±103.6，95％CI：-47.26至552.8）和椭球区（EZ，496.7±101.6 vs 766.7±111.8，95％CI：-50.29至590.4）缺陷在后续检查的第6个月，NGF组的头皮明显变小。在NGF组中，分别在一只患者的一只眼和两只患者的两只眼中观察到ELM和EZ完全恢复。相比之下，ILM插入组中一只眼睛的ELM和另一只眼睛的EZ已完全恢复。结论我们的结果表明，NGF注射ILM可能是对大MHs眼进行初始手术治疗的有效技术。拟议的方法产生了更好的感光层恢复，因此可能具有更高的术后视力。试用注册码：CRT1900021711。追溯注册于2019年3月5日。