Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Epiretinal membrane recurrence
研究概览
简要总结
The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or older than 19 years
- •Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery
排除标准
- •Accompanied with retinal vascular disease or intraocular inflammation
- •Prior treatment with vitrectomy in the study eye
- •History of glaucoma
结局指标
主要结局
Epiretinal membrane recurrence
时间窗: 12 months after the surgery
Recurrence of the epiretinal membrane after the surgery
次要结局
- Best-corrected visual acuity(12 months after the surgery)
- M-chart(12 months after the surgery)
- Aniseikonia(12 months after the surgery)
研究者
Un Chul Park
Associate Professor
Seoul National University Hospital