Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Agreement of Intraocular Pressure
研究概览
简要总结
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.
The secondary objective was to demonstrate that the test device was as safe as the predicate device.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject had to have:
- •been at least 22 years of age of either sex and any race or ethnicity;
- •been willing and able to provide written informed consent prior to any study procedures being performed;
- •been willing and able to follow all instructions and attend all study visits;
- •corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.
排除标准
- •Each subject had to not to :
- •have only one functional eye;
- •have poor or eccentric fixation in the study eye;
- •have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
- •have microphthalmos in the study eye;
- •have buphthalmos in the study eye;
- •be a contact lens wearer in the study eye;
- •have dry eyes;
- •be a lid squeezer - blepharospasm;
- •have nystagmus in the study eye;
- •have keratoconus in the study eye;
- •have any other corneal or conjunctival pathology or infection in the study eye;
- •use medication that affect IOP;
- •current participation in other clinical trials;
- •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.
研究组 & 干预措施
TONOREF III and Goldmann Tonometer Measurements
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
干预措施: NIDEK TONOREF III (Device)
TONOREF III and Goldmann Tonometer Measurements
Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).
干预措施: Haag-Streit Goldmann Manual Tonometer (Device)
结局指标
主要结局
Agreement of Intraocular Pressure
时间窗: 1-2 study visits per subject over the course of 8 days
Agreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)
次要结局
- The Numbers of Adverse Events(1-2 study visits per subject over the course of 8 days)