NCT05283343已完成不适用
Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Corneal thickness
研究概览
简要总结
Agreement and Precision of corneal thickness measurement (pachymetry) function of the test device TRK-3 and the predicate device SP-1P will be evaluated in volunteers, and safety will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who gave written informed consent to participate in the clinical trial by their free will.
- •Individuals who aged 20 years or older at the time of informed consent
- •Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment.
- •Subjects who are able to comply with compliance items during participation in the clinical trial, undergo medical examination and examination specified in the protocol, and report subjective symptoms, etc.
排除标准
- •Individuals with ocular diseases that may affect corneal thickness measurement (blindness, corneal perforation, bullous keratopathy, nystagmus, etc.) or who have a history of ocular diseases and are considered by the investigator to be ineligible for participation in the study.
- •Individuals who have or are suspected of suffering from ocular or systemic infections.
- •Other persons who are judged by the investigator to be unfavorable candidates for the study.
结局指标
主要结局
Corneal thickness
时间窗: 1 day
Corneal thickness
次要结局
未报告次要终点
研究者
研究点 (1)
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