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临床试验/NCT05269563
NCT05269563已完成不适用

Double Flap Technique Utilizing ERM and ILM for Macular Hole

Omer Othman Abdullah2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Ocular coherence tomography

研究概览

简要总结

Double flapping technique to close the macular hole.

详细描述

Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.

Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.

Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.

The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

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

  • Full thickness macular hole

排除标准

  • Partial-thickness macular hole
  • Vitreomacular traction

结局指标

主要结局

Ocular coherence tomography

时间窗: The fourth week post-operatively

The closure of the hole can be assessed clearly

次要结局

未报告次要终点

研究者

发起方
Omer Othman Abdullah
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Omer Othman Abdullah

Associate consultant ophthalmologist

Ibinsina Modern Eye and Retina Center

研究点 (2)

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