NCT02030262已完成不适用
Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
CHU de Quebec-Universite Laval1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年12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
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.
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
- Single (Participant)
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
- •Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
- •ETDRS visual acuity worse or equal to 20/30
- •Adult able to give consent
排除标准
- •Diagnosis of age-related macular degeneration
- •Opacity blocking the fundus visualisation
- •Presence of active intraocular inflammation
- •Presence of intraocular tumor
- •Presence of retinal detachment
研究组 & 干预措施
Air
Experimental
The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms.
干预措施: Epiretinal membrane peeling with fluid-air exchange (Procedure)
Sulfur hexafluoride (SF6)
Active Comparator
The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same.
干预措施: Epiretinal membrane peeling with fluid-SF6 exchange (Procedure)
结局指标
主要结局
Visual acuity
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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