A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Change from baseline in visual acuity at 6 months post-surgery (intervention)
研究概览
简要总结
Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has been performed to remove the membranes with few complications, and surgical results are generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM surgery have been popularized by a number of retrospective studies and one prospective case series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable and transparent ILM is difficult and increases the risk of trauma to the retina. In addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization, is costly and has been shown to be toxic to the retina. The investigators study will be the first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM surgery with and without ILM peeling. The results will help guide and standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help economize healthcare cost.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •ERM on clinical exam and/or macular OCT
- •Visual acuity of 20/40 or worse (attributable to ERM)
排除标准
- •Prior surgery for ERM in the "study eye"
- •Macular edema secondary to arterial/venous occlusion(s)
- •Central serous retinopathy
- •Age related macular degeneration
- •Diabetic cystoid macular edema
- •Proliferative Diabetic Retinopathy
研究组 & 干预措施
Epiretinal Membrane Surgery without ILM peel
干预措施: Pars plana vitrectomy and epiretinal membrane peel (Procedure)
Epiretinal Membrane Surgery with ILM peel (ICG assisted)
干预措施: Pars plana vitrectomy and epiretinal membrane peel (Procedure)
Epiretinal Membrane Surgery with ILM peel (ICG assisted)
干预措施: ILM peel assisted by ICG (Procedure)
Combined CE & IOL and ERM surgery without ILM peel
干预措施: Pars plana vitrectomy and epiretinal membrane peel (Procedure)
Combined CE & IOL and ERM surgery without ILM peel
干预措施: CE-IOL (Procedure)
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)
干预措施: Pars plana vitrectomy and epiretinal membrane peel (Procedure)
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)
干预措施: ILM peel assisted by ICG (Procedure)
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)
干预措施: CE-IOL (Procedure)
结局指标
主要结局
Change from baseline in visual acuity at 6 months post-surgery (intervention)
时间窗: Comparing change of visual acuity at 6 months following surgery and baseline
Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)
时间窗: Comparing change at 6 months following surgery and baseline
次要结局
- Change from baseline in visual acuity at 1 month post-surgery (intervention)(1 month following surgery (intervention))
- Change from baseline in visual acuity at 3 months post-surgery (intervention)(3 months following surgery (intervention))
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)(1 month following surgery (intervention))
- Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery(12 months following surgery)
- Change from baseline in visual acuity at 12 months post-surgery (intervention)(12 months following surgery (intervention))
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)(3 months following surgery)
- Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)(1 month following surgery)
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)(6 months following surgery)
- Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)(12 months following surgery)