Department of Ophthalmology, Shanghai General Hospital, Shanghai, China.
National Clinical Research Center for Eye Diseases, Shanghai, People's Republic of China.
BMJ Open. 2022 Jul 28;12(7):e064299. doi: 10.1136/bmjopen-2022-064299.
Vitrectomy combined with internal limiting membrane (ILM) peeling, flap or tamponade is widely used in the treatment of macular diseases, such as macular hole (MH) and high myopia macular hole retinal detachment (HMMHRD). However, movement of the ILM to a suitable position to prevent displacement is a difficult operation. Improving visual function after surgery remains controversial. Compared with ILM, the thicker and more flexible lens capsule is easy to obtain and operate. Previous studies have confirmed the effectiveness of lens capsule flap in the treatment of MH. This study aims to evaluate the efficacy and safety of vitrectomy combined with lens capsule flap transplantation in the treatment of HMMHRD.
This single-centre, single-blind, prospective, randomised clinical trial will include 54 patients with HMMHRD who will first undergo phacoemulsification and intraocular lens implantation and then vitrectomy combined with lens capsule flap transplantation (experimental group) or ILM tamponade (control group). Study participants will be randomly allocated in a 1:1 ratio to experimental and control groups. Follow-up will be conducted 1, 3 and 7 days and 1, 3 and 6 months after surgery in both groups. Necessary examinations will be performed at each follow-up visit. Measurement outcomes include postoperative situation of macular hole closure, best-corrected visual acuity, macular retinal function and macular retinal sensitivity. The primary outcome is type I closure rate of MH 6 months after operation. Intergroup comparisons of the proportions of patients with type I closure of MH will be performed with Fisher's exact test.
Full ethics approval for this study was obtained from the Ethics Committee of Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, China. The outcomes of the trial will be disseminated through peer-reviewed journals and at scientific conferences.
ChiCTR2200057836.
玻璃体切除术联合内界膜（ILM）剥除、翻转或填塞术广泛应用于黄斑疾病的治疗，如黄斑裂孔（MH）和高度近视黄斑裂孔视网膜脱离（HMMHRD）。然而，将 ILM 移动到合适的位置以防止移位是一项困难的操作。手术后视力功能的改善仍存在争议。与 ILM 相比，更厚、更灵活的晶状体囊更容易获得和操作。先前的研究已经证实了晶状体囊瓣在 MH 治疗中的有效性。本研究旨在评估玻璃体切除联合晶状体囊瓣移植治疗 HMMHRD 的疗效和安全性。
这是一项单中心、单盲、前瞻性、随机临床试验，将包括 54 例 HMMHRD 患者，他们将首先接受超声乳化白内障吸除术和人工晶状体植入术，然后接受玻璃体切除联合晶状体囊瓣移植（实验组）或 ILM 填塞（对照组）。研究参与者将以 1:1 的比例随机分配到实验组和对照组。两组均在术后 1、3 和 7 天及 1、3 和 6 个月进行随访。每次随访时都将进行必要的检查。测量结果包括黄斑裂孔闭合情况、最佳矫正视力、黄斑视网膜功能和黄斑视网膜敏感性。主要结局是术后 6 个月 MH Ⅰ型闭合率。采用 Fisher 确切检验比较两组 MH Ⅰ型闭合患者的比例。
本研究已获得上海交通大学附属上海总医院伦理委员会的充分伦理批准。试验结果将通过同行评议期刊和科学会议进行传播。
ChiCTR2200057836。
