内界膜剥除范围对黄斑裂孔手术解剖结果的影响：一项 54 周随机临床试验结果。

The impact of extent of internal limiting membrane peeling on anatomical outcomes of macular hole surgery: results of a 54-week randomized clinical trial.

机构信息

Department of Ophthalmology, Peking University People's Hospital, Beijing, China.

Key Laboratory of Vision Loss and Restoration, Ministry of Education, Beijing Key Laboratory for the Diagnosis and Treatment of Retinal and Choroid Diseases, Beijing, China.

出版信息

Acta Ophthalmol. 2019 May;97(3):303-312. doi: 10.1111/aos.13853. Epub 2018 Sep 5.

PURPOSE

To compare the anatomical outcomes of different extents of internal limiting membrane (ILM) peeling in idiopathic macular hole surgery.

METHODS

Prospective, parallel-group, randomized clinical trial. A total of 121 eyes of 121 patients with idiopathic macular hole underwent pars plana vitrectomy, and peeling of the ILM with a diameter of two disk diameters (DD) or 4DD based on randomization. The main outcome was the proportion of eyes with complete hole closure at 12 months. The second outcome was the hole closure grading stratified by macular hole closure index (MHCI) at each visit.

RESULTS

At 12 months, there was no significant difference in anatomical outcomes with complete closure achieved in 52 (82.5%) of 63 eyes in the 2DD group and 53 (91.4%) of 58 eyes in the 4DD group (p = 0.15). For subjects with MHCI ≤0.5 (n = 24), complete closure rate was significantly lower in the 2DD group compared to the 4DD group (p = 0.012; 18.2% versus 75.9%, respectively). Average BCVA was lower in 2DD group than 4DD group (p = 0.014). By contrast, when MHCI was >0.5, the complete closure rate between the two groups showed no significant difference: 96.2% (50 patients) versus 95.6% (43 patients), respectively (p = 0.185).

CONCLUSION

In patients with idiopathic full-thickness macular hole and MHCI ≤0.5, a larger ILM peel of 4DD tends to achieve better anatomical outcomes than a more limited 2DD peel.

目的

比较不同范围内界膜（ILM）剥除治疗特发性黄斑裂孔手术的解剖学结果。

方法

前瞻性、平行分组、随机临床试验。共纳入 121 例（121 只眼）特发性黄斑裂孔患者，根据随机分组行标准经睫状体平坦部玻璃体切除术，ILM 以 2 个视盘直径（DD）或 4DD 直径行剥膜。主要结局为术后 12 个月时完全裂孔闭合的眼比例。次要结局为根据黄斑裂孔闭合指数（MHCI）在每次随访时对裂孔闭合分级。

结果

术后 12 个月，2DD 组 63 只眼中有 52 只（82.5%）和 4DD 组 58 只眼中有 53 只（91.4%）完全裂孔闭合，两组间解剖学结局无显著差异（p=0.15）。对于 MHCI≤0.5（n=24）的患者，2DD 组完全闭合率明显低于 4DD 组（p=0.012；分别为 18.2%和 75.9%）。2DD 组平均 BCVA 低于 4DD 组（p=0.014）。相比之下，当 MHCI＞0.5 时，两组间完全闭合率无显著差异：分别为 96.2%（50 例）和 95.6%（43 例）（p=0.185）。