Zheng Ying, Kang Mei, Wang Hong, Liu Haiyun, Sun Tao, Sun Xiaodong, Wang Fenghua
Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Building 1, No.100, Haining Road, Shanghai, 200080, China.
Clinical Research Center, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Trials. 2018 Aug 30;19(1):469. doi: 10.1186/s13063-018-2833-y.
Macular hole retinal detachment (MHRD) occurs most commonly in high myopia and causes severe visual impairment and greatly reduces the quality of life. The aim of this study is to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also to compare the treatment efficacy with that of the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method for high myopia-associated MHRD.
METHODS/DESIGN: In this clinical trial, 38 patients with MHRD in high myopia will be randomly assigned to two groups (Group 1: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus air-fluid exchange plus silicone oil infusion; Group 2: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus inverted internal limiting membrane insertion plus air-fluid exchange). The primary outcome is macular hole closure rate in 3 months after the initial surgery. The secondary outcomes are best corrected visual acuity (BCVA), reattachment rate of retinal detachment, and postoperative complication rate.
The study results may help to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also compare the efficacy of the new treatment with the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method. This trial may provide a novel surgical treatment for MHRD in high myopia with more effectiveness and less pain.
ClinicalTrials.gov, NCT03383731 . Registered on 19 December 2017. Retrospectively registered.
黄斑裂孔性视网膜脱离（MHRD）最常发生于高度近视，可导致严重视力损害并极大降低生活质量。本研究旨在评估内界膜倒置插入联合空气填塞治疗高度近视性MHRD的疗效和安全性，并将其治疗效果与传统的“玻璃体切除术联合内界膜剥除联合硅油填塞”方法治疗高度近视相关性MHRD的效果进行比较。
方法/设计：在本临床试验中，38例高度近视性MHRD患者将被随机分为两组（第1组：标准三通道23G经睫状体平坦部玻璃体切除术联合内界膜剥除联合气液交换联合硅油注入；第2组：标准三通道23G经睫状体平坦部玻璃体切除术联合内界膜剥除联合内界膜倒置插入联合气液交换）。主要结局指标为初次手术后3个月黄斑裂孔闭合率。次要结局指标为最佳矫正视力（BCVA）、视网膜脱离复位率和术后并发症发生率。
研究结果可能有助于评估内界膜倒置插入联合空气填塞治疗高度近视性MHRD的疗效和安全性，并比较新治疗方法与传统的“玻璃体切除术联合内界膜剥除联合硅油填塞”方法的疗效。本试验可能为高度近视性MHRD提供一种更有效且疼痛更少的新型手术治疗方法。
ClinicalTrials.gov，NCT03383731。于2017年12月19日注册。回顾性注册。
