Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Coefficients of variation of oxygen measurement
研究概览
简要总结
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although this is a well known fact, measurement of oxygen saturation in the eye is still a delicate and not fully explored task. However, recently a new instrument for the non-invasive measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data about reproducibility in humans is yet available for this instrument. Consequently, the current study seeks to evaluate the short term and day to day reproducibility of retinal vessel oxygenation in healthy volunteers.
20 healthy volunteers will be included and oxygen saturation of retinal vessels will be determined. The reproducibility of the results will be tested by repeated measurements and the collected data will be independently analyzed by two observers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women aged between 18 and 35 years,
- •Nonsmokers
- •Body mass index between 15th and 85th percentile
- •Normal ophthalmic findings, ametropia < 3 Dpt.
排除标准
- •Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug except oral contraceptives
- •Symptoms of a clinically relevant illness in the 3 weeks before the study day
- •Blood donation during the previous 3 weeks
结局指标
主要结局
Coefficients of variation of oxygen measurement
时间窗: 5 measurements on both study days
次要结局
未报告次要终点
研究者
Gerhard Garhofer
Ass.Prof.Dr.med.
Medical University of Vienna