NCT06363045已完成不适用
Comparative Study of the NIDEK TONOREF III with the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III with the NIDEK CEM-530 for Pachymetry Function
Nidek Co. LTD.2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2024年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Equivalent to legally-marketed devices
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
- •Exclusion criteria
- •Subjects with only one functional eye;
- •Those with one eye having poor or eccentric fixation;
- •Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
- •Microphthalmos;
- •Buphthalmos;
- •Contact lens wearers;
- •Lid squeezers - blepharospasm;
- •Keratoconus;
- •Any other corneal or conjunctival pathology or infection.
- •central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
排除标准
- 未提供
结局指标
主要结局
Equivalent to legally-marketed devices
时间窗: One or two study visits per subject. One visit is less than two hours.
Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT
Equivalent to the pachymeter function
时间窗: One or two study visits per subject. One visit is less than two hours.
Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530
次要结局
- The numbers of adverse events(One or two study visits per subject. One visit is less than two hours.)
研究者
研究点 (2)
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