NCT01972997已完成4 期
A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects
Sensimed AG1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit
研究概览
简要总结
This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.
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
- Double (Participant, Investigator)
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 ocular disease
- •Aged ≥ 18 years, of either sex
- •Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
- •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
- •Severe dry eye 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
- •Any other contra-indication listed in the TF user manual
结局指标
主要结局
The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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