The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Central Cornea Thickness
研究概览
简要总结
This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)
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
- •Normal Anterior Segment
- •Age 22 years or older
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •Able to fixate
- •Eye(s) with normal anterior segment
排除标准
- •Normal Anterior Segment
- •Active infection or inflammation in the study 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 2 weeks prior to imaging
- •Soft lenses worn within one hour prior to imaging
- •Cataract grade ≥1.5
- •Inclusion Criteria Abnormal Anterior Segment
- •Age 22 years or older
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •Able to fixate
- •Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)
- •Exclusion Criteria Abnormal Anterior Segment
- •Active infection or inflammation in the study 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 2 weeks prior to imaging
- •Soft lenses worn within one hour prior to imaging
结局指标
主要结局
Central Cornea Thickness
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of Central Cornea Thickness of ANTERION and the reference device
Thinnest Point Thickness
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of Thinnest Point Thickness of ANTERION and the reference device
Anterior Chamber Depth
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of Anterior Chamber Depth of ANTERION and the reference device
Axial Length
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of Axial Length of ANTERION and the reference device
Lens Thickness
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of Lens Thickness of ANTERION and the reference device
次要结局
- Adverse Events Rate(Through study completion, an average of 1 day)