Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Agreement of Intraocular Pressure
研究概览
简要总结
The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.
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
- •be at least 18 years of age of either sex and any race or ethnicity;
- •be willing and able to provide written informed consent prior to any study procedures being performed;
- •be willing and able to follow all instructions and attend all study visits;
排除标准
- •have only one functional eye;
- •have poor or eccentric fixation in either eye;
- •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, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
- •have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears;
- •be a lid squeezer - blepharospasm;
- •have nystagmus in either eye;
- •have keratoconus in either eye;
- •have any other corneal or conjunctival pathology or infection in either eye;
- •have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
结局指标
主要结局
Agreement of Intraocular Pressure
时间窗: 1 day
Agreement of the measured IOP between the test device and the predicate device for the tonometer function of NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measures table.
Agreement of Corneal Thickness
时间窗: 1 day
Agreement of the measured corneal thickness between the test device and the predicate device for the pachymeter function of the NIDEK TONOREF III. The mean difference and the standard deviation between these two devices are shown in the outcome measure table.
次要结局
- Number of Occurrences of Adverse Events(1day)