Detection of Induced IOP Fluctuations by SENSIMED Triggerfish® in Pigmentary Syndrome and Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- SENSIMED Triggerfish output values
研究概览
简要总结
This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish® device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes
- •IOP of ≥ 15 mmHg
- •18-60 years.
- •Patients able to jog continuously for at least 25 minutes
- •Phakic eyes
- •Patients who accept signing an informed consent approved by the Ethics Committee.
排除标准
- •Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in any eye
- •Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye
- •Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. Following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients
- •Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye
- •Patients not able to understand the nature of the research
- •Patients under tutorship
- •Corneal abnormality
- •Subjects with contraindications for wearing contact lenses
- •Full frame metal glasses during SENSIMED Triggerfish® monitoring
- •History of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures
- •Ocular inflammation or infection
- •History of cardiac or pulmonary disorder
- •Pregnancy and lactation
- •Simultaneous participation in other clinical research
结局指标
主要结局
SENSIMED Triggerfish output values
时间窗: during 4 to 6 hours
Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation
Goldmann Applanation Tonometry values
时间窗: During 4 to 6 hours
GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring
次要结局
未报告次要终点