Effect of Peeling of the Internal Limiting Membrane on Vision Results After Primary Vitrectomy for Retinal Detachment Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Additional peeling of the internal limiting membrane (ILM) was reported to successfully prevent development of epiretinal membranes after surgery. The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
详细描述
Retinal detachment is a disorder, usually caused by peripheral retinal breaks, that leads to severe decrease in vision in untreated cases. Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Recent retrospective studies support the hypothesis, that peeling of the internal limiting membrane (ILM) is beneficial on postoperative visual acuity and lower rates of occurrence of epiretinal membranes after surgery [Forlini et al. 2018].
The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
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)
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
- •retinal detachment
- •age: 18 or older
- •written informed consent for surgery and participation in the study prior to surgery
排除标准
- •pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
研究组 & 干预措施
ILM-Peeling
干预措施: ILM-Peeling (Procedure)
No Peeling
干预措施: No Peeling (Procedure)
结局指标
主要结局
visual acuity
时间窗: from enrollment to the end of follow-up at 4 years after surgery
次要结局
- occurrence of epiretinal membranes(from enrollment to the follow-up at 4 years after surgery)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of department
Vienna Institute for Research in Ocular Surgery