改良内界膜瓣覆盖技术治疗较大直径特发性黄斑裂孔的效果观察

目的 观察玻璃体切除术（PPV）联合改良内界膜（ILM）瓣技术治疗较大直径特发性黄斑裂孔（IMH）的效果。设计 随机对照临床试验。研究对象 60例（60眼）IMH患者，其中男性7例（7眼），年龄46~73岁，黄斑裂孔最大直径均≥600 μm。方法 以数字表法将患者随机分为A组和B组，每组30例，A组治疗采用PPV联合ILM填塞术，B组采用单层ILM瓣覆盖术。主要指标 术前，术后1周，1、3、6个月的最佳矫正视力（BCVA）和黄斑中心凹视网膜厚度（CMT），视网膜外层结构层次清晰性和规整性，黄斑区视网膜下高反射物质存留和黄斑区瘢痕。结果 术后两组患眼裂孔全部闭合。两组间对应时间点的术后BCVA无统计学意义（P均＞0.05）。A组、B组术后1个月BCVA分别为（1.17±0.29）、（1.13±0.25），较术前的（1.47±0.38）、（1.45±0.33），较术后1周的（1.40±0.34）、（1.39±0.31）均有提高（P均＜0.01）；术后3个月（0.88±0.26）、（0.85±0.27）、6个月（0.81±0.24）、（0.78±0.21）均较术后1个月提高（P均＜0.01）；术后3个月与6个月间无差异（P均>0.05）。两组之间比较术前、术后1、3个月CMT无差异（P均＞0.05）。A组、B组术后1周CMT（275.34±18.76）μm、（266.58±18.26）μm较术前的（254.32±17.83）、（252.17±17.12）明显增厚（P均＜0.01）；术后6个月（238.49±24.43）μm、（236.52±22.71）μm较术前明显变薄（P均＜0.01）。术后各时间点两组间外层结构可辨性及平滑规整性无统计差异（P均＞0.05）。60例术前均有高反射信号，术后两组有6病例在黄斑区结构内仍有明显高反射信号，其余54例在术后1~3个月逐渐变小消失。术后6个月时A组2例黄斑区瘢痕愈合。结论 PPV联合改良内界膜（ILM）瓣技术相较于单层ILM瓣覆盖术治疗较大直径IMH的临床疗效较好，能有效封闭裂孔促使黄斑结构的恢复。（眼科， 2022， 31： 369-374）

Clinical observation of improved inner limiting membrane flap covering technique for treatment of large diameter IMH

Objective To observe the clinical effect of vitrectomy (PPV) combined with modified internal limiting membrane (ILM) flap in the treatment of large diameter idiopathic macular hole (IMH). Design Randomized controlled trial. Participants A total of 60 IMH patients were included in the study, including 7 males (7 eyes), aged 46-73 years. The maximum diameters of macular hole were all ≥600 μm. Methods 60 patients were randomly divided into group A and group B. 30 patients in each group were treated with PPV combined with ILM tamponade in group A, group B was treated with single ILM flap coverage. Main Outcome Measures BCVA, CMT, the clarity and regularity of the outer layer of the retina, the retention of subretinal hyperreflexive substances in the macular region and the scar in the macular region were measured before, 1 week, 1, 3 and 6 months after the operation. Results All postoperative fissures were closed in both groups. The postoperative BCVA at the corresponding time points between the two groups was not statistically significant (all P>0.05). There was a difference in BCVA from 1 month postoperatively (1.17±0.29), (1.13±0.25) compared to BCVA at 1 week postoperatively (1.47±0.38), (1.45±0.33), (1.40±0.34), and (1.39±0.31) within the two groups (all P<0.01), and within the group at 3 months postoperatively (0.88±0.26), (0.85±0.27), 6 months (0.81±0.24), (0.78±0.21) compared with 1 month postoperatively also differed (all P<0.01). There was no significant difference between 3 and 6 months postoperatively (all P>0.05). The results of CMT in both groups basically did not change significantly (all P>0.05) preoperatively, at 1 month postoperatively, and at about 3 months postoperatively. However, the CMT in the group was significantly thickened at 1 week postoperatively (275.34±18.76) and (266.58±18.26) relative to preoperatively (254.32±17.83) and (252.17±17.12) (all P<0.01), and at 6 months postoperatively (238.49±24.43) and (236.52±22.71) compared to preoperatively compared with the preoperative period (all P<0.01). There was no statistical difference between the two groups in the time points corresponding to the discernibility of the outer layer structure and smoothness and regularity after surgery (all P>0.05). All 60 patients showed hyperreflesive signals preoperation. After operation, 6 cases in the two groups still showed obvious hyperreflexive signals in the macular structure, and the remaining 54 cases gradually became smaller and disappeared in 1~3 months after operation. Conclusion PPV combined with ILM flap has a significant clinical effect in the treatment of large-diameter IMH. It can effectively close the hole and promote the recovery of macular structure. (Ophthalmol CHN, 2022, 31: 369-374)