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临床试验/NCT04011007
NCT04011007已完成不适用

Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

University of Alexandria1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
visual acuity at one year

研究概览

简要总结

The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling.

This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery.

Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery.

Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • macular hole retinal detachment in high myopic eyes.

排除标准

  • eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.

研究组 & 干预措施

vitrectomy without ILM peeling

Active Comparator

vitrectomy without ILM peeling

干预措施: vitrectomy with or without inverted ILM flap technique (Procedure)

vitrectomy with inverted ILM flap technique

Active Comparator

vitrectomy with inverted ILM flap technique

干预措施: vitrectomy with or without inverted ILM flap technique (Procedure)

结局指标

主要结局

visual acuity at one year

时间窗: 12 months

次要结局

  • rate of retinal attachment and macular hole closure.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Abouhussein

Assistant professor

University of Alexandria

研究点 (1)

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