Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
研究概览
简要总结
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.
详细描述
32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.
After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer without previous ocular medical history
- •18 years or more at inclusion
- •Maximal weight: 100kg
- •BMI lower or equal to 30 kg/m2
- •Subjects having provided informed consent
排除标准
- •Silicone allergy
- •Cardiovascular disease
- •Narrow or closed iridocorneal angle
结局指标
主要结局
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
时间窗: 30-45 min after WDT
次要结局
未报告次要终点