NCT05191628终止2 期
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
TBF Genie Tissulaire2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年6月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Closure of recurrent macular hole
研究概览
简要总结
The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous 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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years of age, less than 75 years
- •Macular Hole of all etiologies
- •Patient with history of opened macular hole after previous pars plana vitrectomy
- •Delay between previous surgery and inclusion (relapse or non-closing hole) > 1 month
- •Patient who received the study information and provided consent
- •Patient who is a members or a beneficiary of a national health insurance plan
排除标准
- •Ocular surgery other than the macular hole surgery in the prior 3 months
- •Participation in other clinical studies in the prior 3 months
- •Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
- •Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
- •Patient with uveitis or other active ocular inflammation or infection
- •Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
- •Person deprived of liberty by judicial or administrative measures
- •Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
结局指标
主要结局
Closure of recurrent macular hole
时间窗: 6 months
Macular hole closure evaluated by optical coherence tomography (OCT)
次要结局
- Functional restoration after closure of the macular hole(7 days, 15 days, 1 month, 3 months, 6 months)
- Evaluation of the surgical technique of placing the membrane(7 days, 15 days, 1 month, 3 months, 6 months)
- Absence of adverse reaction(7 days, 15 days, 1 month, 3 months, 6 months)
- Anatomical restoration(1 month, 3 months, 6 months)
研究者
研究点 (2)
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