Intraocular Pressure Data Collection With Tonometers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Primary Objective
研究概览
简要总结
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).
The intraocular pressure of the participants will be measured with four different tonometers.
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
- 是
入选标准
- •Age ≥ 18 years
排除标准
- •Subjects with only one functional eye
- •Subjects having poor or eccentric fixation in the study eye(s)
- •High corneal astigmatism >3D in the study eye(s)
- •Central corneal scarring
- •History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
- •Microphthalmos
- •Buphthalmos
- •Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
- •Dry eyes (clinically significant)
- •Lid squeezers - blepharospasm
- •Nystagmus
- •Keratoconus
- •Any other corneal or conjunctival pathology or infection relevant to this study
- •Cataract Extraction within last 2 months in the study eye(s)
研究组 & 干预措施
Measurement of IOP Values
Measurement of IOP pressure with four different tonometers.
干预措施: iCare IC1000 (Device)
Measurement of IOP Values
Measurement of IOP pressure with four different tonometers.
干预措施: iCare ST500 (Device)
Measurement of IOP Values
Measurement of IOP pressure with four different tonometers.
干预措施: iCare IC200 (Device)
Measurement of IOP Values
Measurement of IOP pressure with four different tonometers.
干预措施: GAT (Device)
结局指标
主要结局
Primary Objective
时间窗: Through study completion, an average of 4 months
The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.
次要结局
未报告次要终点