NCT01391078已完成不适用
Comparison of Sensimed Triggerfish (TF) 24 Hour IOP Monitoring With Goldmann Applanation Tonometry (GAT) and Perkins Tonometry in Glaucoma Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Relation of GAT/Perkins with TF in a cross-over regression analysis.
研究概览
简要总结
This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to comply with the study procedure
- •Patient must be ≥ 18 years old
- •Diagnosis of primary open angle glaucoma (EGS criteria)
- •Similar behaviour of IOP in both eyes in former IOP profiles
- •Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- •Visual Acuity of 20/200 or better in both eyes
- •Ability of subject to understand the character and individual consequences of the study
- •For women with childbearing potential, adequate contraception
排除标准
- 未提供
研究组 & 干预措施
Sensimed Triggerfish
Experimental
干预措施: Sensimed Triggerfish Sensor (Device)
Goldmann Applanation Tonometry/Perkins Tonometry
Active Comparator
干预措施: Goldmann Applanation Tonometry, Perkins Tonometry (Device)
结局指标
主要结局
Relation of GAT/Perkins with TF in a cross-over regression analysis.
时间窗: 48 hours
Correlation of GAT/Perkins values with TF data (mean, min, max, fluctuation)
次要结局
- Correlation of IOP in the test eye (TF) compared to a conventional 24h IOP profile (GAT) the reference eye (same night)(48 hours)
- Correlation of IOP profile (GAT) right versus left eye(48 hours)
- Correlation of IOP profile (TF) right versus left eye(48 hours)
- Correlation of IOP with blood pressure(48 hours)
- Correlation of IOP with heart rate(48 hours)
研究者
Katrin Lorenz
MD
Johannes Gutenberg University Mainz
研究点 (1)
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