A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With SENSIMED Triggerfish® in Healthy Subjects With Closed Eye
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye
研究概览
简要总结
This study investigates the effect of eye opening/closure on the quality of IOP (intraocular pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject without previous ophthalmic medical history (except from indication for glasses)
- •Aged ≥18 years, of either sex
- •Have given written informed consent, prior to any investigational procedures
排除标准
- •Patients with allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Patients not able to understand the character and individual consequences of the investigation
- •Participation in other clinical research within the last 4 weeks
结局指标
主要结局
The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye
时间窗: 24 hours
TF will be installed on subjects' eyes for 24 hours in two sessions. In one session the eye will remain open (except during sleep) while in the other session the eye will be closed using an ophthalmic patch throughout the 24 hours. For both sessions, the initial TF output value in millivolt equivalent will be subtracted from the final output value to yield the difference from start to end. The difference obtained in the session with closed eye will be divided by that of the session with open eye (ratio).
次要结局
未报告次要终点