NCT01627977已完成3 期
A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Visibility of the membrane after injection of the dye
研究概览
简要总结
The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.
详细描述
Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years, both gender
- •Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
- •Indication of surgical treatment for removal of the epiretinal membrane
排除标准
- •Any history of eye disease
- •Eye infection affecting any structure provided eye
结局指标
主要结局
Visibility of the membrane after injection of the dye
时间窗: during the surgery
The visibility of the membrane after injection of the dye should be graduated by the physician as Bad, OR Fair, OR Good, OR Very Good
次要结局
- Usefulness of the dye(at the end of surgery)
- Degree of impregnation of the dye(during the surgery)
研究者
Rubens Belfort Jr.
Head Professor of the Departament of Ophthalmology
Federal University of São Paulo
研究点 (2)
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