The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anatomical restoration of macular hole closure
研究概览
简要总结
Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.
详细描述
It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
- •Opened holes after 1 month of the surgery.
- •Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm).
排除标准
- •All other causes of macular hole (traumatic and idiopathic)
- •Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.
研究组 & 干预措施
Recurrent opened macular hole
Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft
干预措施: Recurrent opened macular hole (Procedure)
结局指标
主要结局
Anatomical restoration of macular hole closure
时间窗: 6 months
Closure of the macular hole
次要结局
- Functional restoration after closure of the macular hole(6 months)
研究者
Hossam Mohamed Moharram
Assistant Professor of Ophthalmology
Minia University