NCT02523339已完成不适用
Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 8
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Suspected central retinal vein occlusion.
- •Informed consent for participation.
- •No treatment before the first oximetry measurement.
排除标准
- •History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
- •History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
- •Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.
结局指标
主要结局
Visual acuity
时间窗: 12 months
Retinal vessel oxygen saturation
时间窗: 12 months
Central retinal thickness
时间窗: 12 months
Presence or absence of ocular neovascularisation
时间窗: 12 months
As determined by gonioscopic examination
次要结局
- Presence or absence of ocular neovascularisation(6 months)
- Central retinal thickness(6 months)
- Visual acuity(6 months)
- Retinal vessel oxygen saturation(6 months)
研究者
Sveinn Hakon Hardarson
Post-doctoral researcher
University of Iceland
研究点 (8)
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