Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retinal oxygen saturation
研究概览
简要总结
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal laboratory values 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 (except oral contraceptive)
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence of any form of anemia
- •Blood donation during the previous 3 weeks
- •Pregnancy
研究组 & 干预措施
100% oxygen breathing
干预措施: 100% oxygen breathing (Drug)
15% oxygen in N2 breathing
干预措施: 15% oxygen in N2 breathing (Drug)
12% oxygen in N2 breathing
干预措施: 12% oxygen in N2 breathing (Drug)
结局指标
主要结局
Retinal oxygen saturation
时间窗: On the study day - during each breathing period (6 times)
次要结局
- Retinal blood flow(On the study day - during each breathing period (6 times))
研究者
Gerhard Garhofer
Assoc. Prof. Priv.-Doz. Dr.
Medical University of Vienna