A Single Center, Prospective, Open Label Study Assessing the Relationship Between the 24-hour Intraocular Pressure Pattern as Determined by Sensimed Triggerfish® and the 24-hour Blood Pressure Pattern in Patients With Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG.
研究概览
简要总结
Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated.
The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of POAG, including progressing normal tension glaucoma (NTG) based on recent or recurrent disc haemorrhage
- •No anti-glaucomatous drug treatment or washed-out for a period of 4 weeks prior to SD0 and absent throughout the study
- •Aged more than 18 years, of either sex
- •Not more than 4 diopters spherical equivalent on both eyes
- •Not more than 2 diopters cylinder equivalent on both eyes
- •Have given written informed consent, prior to pre-study screening
排除标准
- •Patients with history of ocular surgery within the last 3 months
- •Corneal or conjunctival abnormality hindering contact lens adaptation
- •Severe dry eye
- •Secondary forms of OAG
- •Patients with systemic hypertension
- •Patients with allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Wear of full frame metallic glasses during Triggerfish® monitoring
- •Patients not able to understand the character and individual consequences of the investigation
- •Simultaneous participation in other clinical research
研究组 & 干预措施
Triggerfish
Device: Sensimed Triggerfish
干预措施: Sensimed Triggerfish® (Device)
结局指标
主要结局
To evaluate the relationship between the 24-hour IOP fluctuations as monitored by Triggerfish® and the 24-hour blood pressure pattern in patients with POAG.
时间窗: 24-hour
次要结局
- Relationship between the nocturnal IOP fluctuation pattern and the diurnal fluctuation pattern (office hours)(24 hours)
- Relationship between the intraocular pulsation frequency and heart rate (HR)(24-hours)
- Nycthemeral IOP pattern(24-hour)
- Relationship between intraocular pulsation amplitude and BP(24-hours)
- Assess safety and tolerability(24-hours)