Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ILM integrity
研究概览
简要总结
Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.
详细描述
Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis.
Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected.
Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCVA < 0,6;
排除标准
- •secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
结局指标
主要结局
ILM integrity
时间窗: intraoperative
Visual intraoperative assessment of the ILM integrity
ILM displacement
时间窗: intraoperative
ILM displacement direction during the formation of detachment and divulsion.
Length and localization of the ILM dialysis
时间窗: intraoperative
Length (in degrees) and localization of the ILM dyalisis
Occurence of ILM dyalisis
时间窗: intraoperative
Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF
次要结局
未报告次要终点
研究者
Lyskin Pavel Vladimirovich, MD, PhD
MD, PhD, ophthalmosurgeon
The S.N. Fyodorov Eye Microsurgery State Institution