Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- SENSIMED Triggerfish Efficacy
研究概览
简要总结
The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.
TF efficacy will be evaluated by demonstrating TF ability to detect:
- The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
- Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).
A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device 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
- None
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
- •Signed informed consent for the investigation
- •Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists
- •No anti-glaucomatous drug treatment or washed-out for 4 weeks
- •IOP symmetry of +/- 3 mmHg between fellow eyes
- •Age 18-80 years
- •Not more than 4 diopters spherical equivalent on both eyes
- •Not more than 2 diopters cylinder equivalent on both eyes
排除标准
- •Patients who have had ocular surgery within the last 3 months.
- •Corneal or conjunctival abnormality hindering contact lens adaptation
- •Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
- •Severe dry eye
- •Secondary forms of open angle glaucoma (OAG)
- •Allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Patients not able to understand the character and individual consequences of the investigation
- •Simultaneous participation in other clinical research
结局指标
主要结局
SENSIMED Triggerfish Efficacy
时间窗: in selected 30-second SENSIMED Triggerfish recording intervals during sleep
Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.
次要结局
未报告次要终点