A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 5
- 主要终点
- The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary
研究概览
简要总结
A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the "healthy" 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject of Caucasian origin
- •Healthy subject without previous ocular disease
- •Aged between 40 and 80 years, of either sex
- •Not more than 6 diopters spherical equivalent in the study eye
- •Having given written informed consent, prior to any investigational procedures
排除标准
- •Corneal or conjunctival abnormality precluding contact lens adaptation
- •Previous refractive surgery
- •Occludable or closed iridocorneal angle
- •Sleep apnea syndrome
- •Subjects with allergy to corneal anesthetic
- •Subjects with contraindications for silicone contact lens wear
- •Subjects 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 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary
时间窗: 24-hour
次要结局
- Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)(24 hours)
- Assessment of corneal biomechanical properties in healthy population (if available)(24 hours)
- Assessment of Safety and tolerability through adverse events(6 months)
- Diurnal and nocturnal IOP patterns in healthy subjects(24 hours)