The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Repeatability and Reproducibility 2
研究概览
简要总结
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 years or older
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •Able to fixate
- •With at least one of following eye status for the corresponding eye population:
- •A. Eye with Open Angle (defined by Spaeth gonioscopy grading)
- •B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)
排除标准
- •Subjects which were enrolled in the B-2018-1 study
- •Active infection or inflammation in either eye
- •Insufficient tear film or corneal reflex
- •Physical inability to be properly positioned at the study devices or eye exam equipment
- •Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place
- •Soft lenses worn within one hour prior to study device acquisitions
结局指标
主要结局
Repeatability and Reproducibility 2
时间窗: 1 day
Reproducibility and repeatability of Angle to Angle distance parameter \[mm\] of ANTERION and the reference device
Agreement 1
时间窗: 1 day
Agreement of Spur to Spur distance parameter \[mm\] between the ANTERION and the reference device
Agreement 2
时间窗: 1 day
Agreement of Angle to Angle distance parameter \[mm\] between the ANTERION and the reference device
Agreement 3
时间窗: 1 day
Agreement of Lens Vault parameter \[µm\] between the ANTERION and the reference device
Agreement 5
时间窗: 1 day
Agreement of TISA parameters \[mm2\] between the ANTERION and the reference device
Repeatability and Reproducibility 5
时间窗: 1 day
Reproducibility and repeatability of TISA parameters \[mm2\] of ANTERION and the reference device
Repeatability and Reproducibility 6
时间窗: 1 day
Reproducibility and repeatability of AOD parameters \[µm\] of ANTERION and the reference device
Agreement 6
时间窗: 1 day
Agreement of AOD parameters \[µm\] between the ANTERION and the reference device
Repeatability and Reproducibility 1
时间窗: 1 day
Reproducibility and repeatability of Spur to Spur distance parameter \[mm\] of ANTERION and the reference device
Repeatability and Reproducibility 3
时间窗: 1 day
Reproducibility and repeatability of Lens Vault parameter \[µm\] of ANTERION and the reference device
Repeatability and Reproducibility 4
时间窗: 1 day
Reproducibility and repeatability of Anterior Segment Angles parameter \[°\] of ANTERION and the reference device
Agreement 4
时间窗: 1 day
Agreement of Anterior Segment Angles parameter \[°\] between the ANTERION and the reference device
次要结局
- Adverse Events Rate(1 day)