NCT05167773已完成不适用
Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
研究概览
简要总结
The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Be 18 years of age or older at the time of informed consent
- •Irrespective of sex
- •Irrespective of race or ethnicity
- •Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures
排除标准
- •Have only one functional eye
- •Have one eye with poor or eccentric fixation
- •Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
- •Have microphthalmos in either eye
- •Have buphthalmos in either eye
- •Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months)
- •Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
- •Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
- •Have nystagmus in either eye
- •Have keratoconus in either eye
- •Have any other corneal or conjunctival pathology or infection in either eye
- •Have central corneal thickness is less than 500μm or more than 600μm
- •Be allergic to eye drop anesthetics
- •Be allergic to sodium fluorescein
结局指标
主要结局
fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
时间窗: 1 day
Intraocular Pressure (IOP) measurements acquired with the study tonometer are compared to the reference tonometer IOP measurements to demonstrate that they meet the requirement specified in the tonometer standards (ISO 8612:2009, JIS T7312:2015 and ANSI Z80.10-2014)
次要结局
未报告次要终点
研究者
研究点 (2)
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