Macular Resurfacing With Non-Inverted Autologous Internal Limiting Membrane Patch Transposition for Idiopathic Epiretinal Membrane: A Multidimensional Evaluation of Efficacy and Foveal Microstructural Remodeling
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
Idiopathic epiretinal membrane is a condition in which abnormal tissue grows on the surface of the retina and can cause blurred vision and distortion. The standard surgical treatment is removal of this membrane, but some patients may not achieve complete visual recovery because the normal structure of the central retina may not fully restore after surgery.
This study is a prospective randomized controlled trial designed to evaluate a new surgical technique called macular resurfacing using an autologous internal limiting membrane patch transposition. The technique uses a patient's own retinal tissue to cover the macular area after epiretinal membrane removal, with the aim of promoting more natural healing of the retinal surface.
Patients with idiopathic epiretinal membrane will be randomly assigned to receive either the new surgical technique or conventional epiretinal membrane peeling. Visual function and retinal structural changes will be evaluated using visual examinations and multimodal retinal imaging during follow-up. The study aims to determine whether this new technique can improve visual outcomes and promote better restoration of macular microstructure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epiretinal membrane confirmed by Spectral-domain Optical Coherence Tomography
- •Best corrected visual acuity <= 0.8 (equivalent to 0.1 LogMAR)
- •Presence of metamorphopsia confirmed by Amsler grid testing
- •Ability to understand the study information and provide written informed consent voluntarily
排除标准
- •History of intraocular surgery, with the exception of uncomplicated cataract surgery
- •Presence of any of the following ocular diseases: retinal vascular diseases (including diabetic retinopathy, retinal hemangioma, retinal vascular occlusion, Coats' disease, etc.), uveitis, macular degeneration, macular hole, retinal detachment, retinoschisis, pathologic myopia, ocular trauma, intraocular tumor and neurofibromatosis.
研究组 & 干预措施
Non-Inverted Autologous ILM Patch Transposition Group
干预措施: Non-Inverted Autologous Internal Limiting Membrane (ILM) Patch Transposition (Procedure)
Conventional ERM/ILM Peeling Group
干预措施: Conventional Epiretinal Membrane and Internal Limiting Membrane Peeling (Procedure)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: From baseline to 12 months
次要结局
未报告次要终点
研究者
Peiquan Zhao
Professor and Chief Physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
