Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acquisition of 24-hour Sensor output signal
研究概览
简要总结
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.
The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years.
- •Untreated IOP of ≥22 mmHg in both eyes.
- •Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
- •Patients under tafluprost treatment since at least 4 weeks in both eyes.
- •Patients who accept signing an informed consent approved by the Ethics Committee.
排除标准
- •Patients not able to understand the nature of the research
- •Patients under tutorship
- •Corneal abnormalities in both eyes
- •Subjects with contraindications for wearing contact lenses
- •History of ocular surgery within the last 3 months
- •Known hypersensitivity to tafluprost or to any of its excipients
- •Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
- •Pregnancy and lactation
- •Simultaneous participation in other clinical research
- •Patients with evidence of ocular infection or inflammation
结局指标
主要结局
Acquisition of 24-hour Sensor output signal
时间窗: After 24-hour continuous recording
Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording.
次要结局
- Possible IOP fluctuation(After 24-hour recording with study device)