Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
研究概览
简要总结
Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).
详细描述
The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be male or female, between the ages of 18 and 90 years old;
- •Be able and willing to provide signed informed consent
- •Be able to follow study instructions
排除标准
- •Subjects with only one functional eye;
- •Subjects with one eye having poor or eccentric fixation;
- •Subjects with central corneal thickness greater than 600 µm or less than 500 µm (about 2 standard deviations the human mean);
- •Subjects with corneal scarring or who have had corneal surgery, including corneal laser surgery;
- •Subjects with concomitant ocular diseases such as: microphthalmos, buphthalmos, nystagmus, keratoconus, severe dry eye syndrome, blepharospasm, any other corneal or conjunctival pathology or infection;
- •Contact lens wearers;
- •Known allergy to proparacaine or fluorescein as these are used to anesthetize the eye and allow IOP measurement, respectively, when used with the GAT.
研究组 & 干预措施
Goldmann Applanation Tonometer
Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.
干预措施: IOP with Goldmann Applanation Tonometer (Device)
ORA G3 and ic100
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.
干预措施: IOP with comparator ORA G3 and ic100 tonometers (Device)
Tono-Vera Tonometer
Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.
干预措施: IOP with Tono-Vera Tonometer (Device)
结局指标
主要结局
Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
时间窗: Through study completion, approximately 4 months.
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The Tono-Vera Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
次要结局
- Data collection for two measurement modes.(Through study completion, approximately 4 months.)
- Data collection for device calibration.(Through study completion, approximately 4 months.)