跳至主要内容
临床试验/NCT06194760
NCT06194760进行中(未招募)不适用

Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 13 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
进行中(未招募)
入组人数
13
试验地点
2
主要终点
BCVA

研究概览

简要总结

Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.

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

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
  • Macular hole and only posterior retinal detachment

排除标准

  • Other causes of RD
  • Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
  • History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery

结局指标

主要结局

BCVA

时间窗: 12 months postoperative

It is a measure of the visual acuity, which will be measured by LogMar

Closure of macular hole

时间窗: 6 months post operative

It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination

次要结局

未报告次要终点

研究者

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

Ehab Tharwat

Principal Investigator

Al-Azhar University

研究点 (2)

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