To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity (BCVA) (metric : LogMAR)
研究概览
简要总结
To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.
详细描述
This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.
Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.
If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.
If the ILM is partially removed, the patient is not enrolled.
The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult up to 18 years old,
- •diagnosed and treated surgically
排除标准
- •proliferative diabetic retinopathy,
- •ocular trauma,
- •central veinous occlusion,
- •intra-ocular tumor, total retinal detachment,
- •central visual field loss in glaucomatous patients
结局指标
主要结局
Best corrected visual acuity (BCVA) (metric : LogMAR)
时间窗: Day 180
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
次要结局
- BCVA at day 15, 1, 3 month.(Day 15, Day 30, Day 90)
- near visual acuity measured at baseline, day 15, 1, 3 and 6 month(Day 180)
- central retinal thickness (CRT)(Day 180)
- peeling initiation retinal thickness(Day 180)
- 10° visual field(Day 180)