NCT00966108已完成不适用
Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients
Sensimed AG1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ocular discomfort on a visual analogue scale
研究概览
简要总结
Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is able to comply with the study procedure
- •Patient is 18-80 years old
- •Healthy subject or glaucoma patient
- •Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- •Cylinder refraction of no more than +/- 2 diopters in the study eye
- •Visual acuity of 20/80 or better in the study eye
- •Ability of subject to understand the character and individual consequences of the study
- •For women with childbearing potential, adequate contraception
排除标准
- •Subjects wearing contact lenses within the last two years
- •Subjects with contraindications for wearing contact lenses
- •History of refractive surgery
- •History of intraocular surgery in the last three months
- •Severe dry eye syndrome
- •Keratoconus or other corneal abnormalities
- •Conjunctival or intraocular inflammation
- •Pregnancy and lactation
- •Simultaneous participation in other clinical trials
结局指标
主要结局
ocular discomfort on a visual analogue scale
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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