NCT06211907招募中不适用
Small Macular Holes Treated With Air: A Prospective Randomized Controlled Multicenter Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 14
- 主要终点
- Macular hole closure after single surgery
研究概览
简要总结
Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Primary MH ≤250 μm
- •MH duration ≤12 months
- •No previous vitreoretinal surgery in study eye
- •Ability to sign informed consent
- •Signed informed consent
- •Age ˃18 years
排除标准
- •Previous vitreoretinal surgery in study eye
- •Secondary MH caused by other conditions than vitreomacular traction
- •Myopic MH, i.e., excessive myopia (more than -6 dioptres)
- •Traumatic MH
- •MH secondary to retinal detachment or other retinal diseases
- •Previously participation in this study
结局指标
主要结局
Macular hole closure after single surgery
时间窗: 4 weeks
Closure verified on OCT
次要结局
- Change in outcome of patient well-being(4 weeks and 4 months)
- Change in visual acuity i ETDRS lines(4 weeks and 4 months)
研究者
研究点 (14)
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