NCT01217853已完成不适用
Comparison of 24-hour Continuous IOP Monitoring With a Contact Lens-based Sensor to Goldmann Applanation Tonometry
Sensimed AG2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010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
- 30
- 试验地点
- 2
- 主要终点
- SENSIMED Triggerfish output values
研究概览
简要总结
A study in which intraocular pressure (IOP) will be monitored over 24 hours using the SENSIMED Triggerfish® device and Goldmann applanation tonometry (GAT) in primary open angle glaucoma patients. The aim of this study is to investigate the comparability of diurnal IOP patterns emerging from SENSIMED Triggerfish and GAT.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent for the investigation
- •Patients with primary open angle glaucoma (POAG), defined as open angle ≥ 30°, confirmed visual field loss (Mean Defect/Least Variance ≤ 2dB) and/or optic nerve head damage (cup disc ratio > 0,5)
- •Age 40-70 years at inclusion
- •Not more than 4 diopters spherical equivalent on the study eye
- •Not more than 2 diopters cylinder equivalent on the study eye
- •For women of childbearing potential, adequate contraception
- •Stable anti-glaucomatous therapy 4 weeks before the first 24-hour IOP assessment session and throughout the investigation
排除标准
- •Patients not able to understand the character and individual consequences of the investigation
- •Patients committed to an institution by virtue of an order issued either by the courts or by an authority
- •Absence of or withdrawn informed consent
- •Patients with contraindications for silicone contact lens wear
- •Wear of full frame metallic glasses during SENSIMED Triggerfish monitoring
- •Eye disorders including severe dry eye
- •Eye disorders secondary to POAG
- •Patient who have had ocular surgery within the last 3 months
- •Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
- •Pregnancy and lactation
- •Allergy to oxybuprocaine (ocular anesthesia)
- •Simultaneous participation in other clinical research
结局指标
主要结局
SENSIMED Triggerfish output values
时间窗: During 24 hours
Patients will undergo one session of 24-hour SENSIMED Triggerfish continuous intraocular pressure monitoring in one eye.
Goldmann applanation tonometry values
时间窗: During 24 hours
Goldmann applanation IOP readings will be done in the other eye at regular intervals during 24-hour SENSIMED Triggerfish IOP monitoring and in both eyes during another 24-hour session.
次要结局
未报告次要终点
研究者
研究点 (2)
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