A Prospective Pilot Study Investigating the Use of a Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure in Healthy Subjects and Patients With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
研究概览
简要总结
Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities.
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time.
Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements < 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording
- •For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy
- •Aged ≥ 18 years, either gender
- •Body Mass Index ≤ 30 kg/m2
- •Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D)
- •Central Corneal Thickness between 500 microns and 600 microns
- •Difference in IOP absolute value between eyes within 2.5 mmHg at screening in sitting position
- •Same direction of IOP variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening
- •Spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters
- •Having given written informed consent, prior to any investigational procedures
排除标准
- •Ocular pathology (other than glaucoma for glaucoma subjects)
- •Previous glaucoma, cataract or refractive surgery
- •Corneal or conjunctival abnormality, precluding contact lens adaptation
- •Severe dry eye syndrome
- •Subjects with allergy to corneal anesthetic
- •Subjects with contraindications for silicone CL wear
- •Subjects with contraindications for Water Drinking Test (WDT) (eg., heart, renal problems)
- •Subjects unable or unwilling to comply with the study procedures
- •Participation in other interventional clinical research within the last 4 weeks
研究组 & 干预措施
Investigational device (Goldfish)
IOP will be monitored for 24 h in the Goldfish eye
干预措施: Goldfish (Device)
Tonometry
IOP will be acquired by standard tonometry at specific times in the the fellow eye
干预措施: Tonometry (Device)
结局指标
主要结局
Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
时间窗: 24 hours
IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device
次要结局
- Wearing discomfort of Goldfish based on visual analogue scale(24 hours)
- Percentage of subjects completing 24-hour session with Goldfish(24 hours)
- Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements(24 hours)
- Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye(24 hours)
- Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours(24 hours)