NCT04969406终止不适用
A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
Intelon Optics, Inc2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
研究概览
简要总结
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age 18 years or older
- •Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
- •Signed Written Informed Consent
排除标准
- •No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
- •Presence of corneal opacity
- •Presence of cortical cataracts visible in an undilated pupil
- •Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
结局指标
主要结局
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
时间窗: Evaluation Visit (within 30 days of the Screening Visit)
A random effect model will be used to assess variation due to device/operator configuration
次要结局
未报告次要终点
研究者
研究点 (2)
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