Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cataract progression assessed by LOCS III and DLI
研究概览
简要总结
This multicenter randomized controlled trial evaluates Minimal Vitrectomy Surgery (MVS) versus conventional vitrectomy for idiopathic epiretinal membrane (ERM). The primary endpoints include visual acuity improvement and cataract progression after 12 months. MVS aims to minimize vitreous removal while ensuring complete membrane removal through adaptive limited vitrectomy.
详细描述
Idiopathic epiretinal membrane (ERM) is characterized by fibrocellular proliferation on the retinal surface, leading to macular edema, metamorphopsia, and visual impairment. Traditional treatment involves pars plana vitrectomy (PPV) with posterior vitreous detachment (PVD) induction and core vitrectomy, which may increase the risk of postoperative cataract.
Minimal Vitrectomy Surgery (MVS) is a modified surgical approach designed to minimize vitreous removal and preserve the hyaloid. The epiretinal membrane is directly peeled through the intact vitreous. If pre-existing vitreous floaters or membrane fragments remain after peeling and cannot be removed safely with micro-forceps, limited localized vitrectomy is selectively performed to eliminate these floaters and avoid postoperative visual disturbances.
This trial aims to evaluate the efficacy and safety of MVS compared to conventional vitrectomy, focusing on visual improvement, macular thickness, cataract progression, ERM recurrence, and intraoperative complications.
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
- Single (Participant)
盲法说明
Participants are masked to the intervention arm assignment. Surgical staff, investigators, and outcomes assessors are not masked due to the nature of the surgical procedures.
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
- •Age ≥ 18 years.
- •Diagnosis of idiopathic epiretinal membrane (ERM) confirmed by clinical examination and OCT imaging.
- •Clear ocular media allowing adequate fundus imaging.
- •Phakic eye.
- •Ability and willingness to provide written informed consent.
排除标准
- •Prior cataract surgery or advanced cataract requiring combined surgery. Co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion).
- •Systemic conditions preventing safe surgery or follow-up.
- •History of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.
结局指标
主要结局
Cataract progression assessed by LOCS III and DLI
时间窗: Baseline, 12 months
Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.
次要结局
- BCVA change from baseline to 12 months(Baseline, 1 week, 1 month, 3 months, 6 months, 12 months)
- Change in central retinal thickness (CRT) by OCT(Baseline, 1 week, 1 month, 3 months, 6 months, 12 months)
- Epiretinal membrane recurrence rate(12 months)
研究者
Weihong Yu
Professor
Peking Union Medical College Hospital