NCT01083004Unknown3 期
A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Best corrected far visual acuity (ETDRS)
研究概览
简要总结
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 50
- •macular pucker or macular hole with subjective disturbances
- •All phakic or pseudophakic patients
- •far visual acuity better than 20/400
- •able to read, understand, and willing to sign the informed consent form
排除标准
- •any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
- •prior vitreoretinal surgery in the study eye
结局指标
主要结局
Best corrected far visual acuity (ETDRS)
时间窗: 1 year postoperative
次要结局
- Reading ability (Radner)(1 Year)
- Optical coherence tomography(1 year)
研究者
研究点 (2)
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