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临床试验/NCT03528122
NCT03528122Unknown不适用

The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole

Minia University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
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

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.

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

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Mohamed Moharram

Assistant Professor of Ophthalmology

Minia University

研究点 (2)

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