Short- and Long-term Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography Measurements in Healthy Subjects - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Retinal blood-flow variation over time
研究概览
简要总结
Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive technique to quantify total retinal blood flow.
To enable further development of this technique it is essential to assess short- and long-term reproducibility of DOCT blood flow measurements.
详细描述
In the present study, total retinal blood flow will be measured with DOCT at multiple time points to gain information of short- and long-term reproducibility. In addition, provocation with flickering light will be performed, which is known to lead to vasodilatation and an increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured using the Dynamic Vessel Analyzer (DVA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Non-smokers
- •Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropy < 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 contraceptives)
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Blood donation during the previous 3 weeks
- •Pregnancy, planned pregnancy or lactating
- •History or family history of epilepsia
结局指标
主要结局
Retinal blood-flow variation over time
时间窗: 14 +/- 3 days
as measured using DOCT
次要结局
- Flicker induced blood flow alterations(14 +/- 3 days)
- Flicker induced vasodilatation and hyperemia(14 +/- 3 days)
研究者
Doreen Schmidl
Associate Professor, MD, PhD
Medical University of Vienna