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临床试验/NCT02030262
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

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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