The Heidelberg Engineering ANTERION Anterior Segment Cornea and IOL Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Precision and Agreement 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 parameters 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 the following eye pathology status for the individual eye population:
- •A. Eye with normal anterior segment and crystalline lens
- •B. Eye with a cataract of grade 1.5 or higher
- •C. Eye with abnormal corneal shape
- •D. Eye with status post-keratorefractive surgery
- •E. Eye without a crystalline lens
排除标准
- •Subjects which were enrolled in the B-2018-1 clinical study
- •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
- •With the following eye pathology status for the individual eye population:
- •A. Eye meets eligibility criteria for eye populations B, C, D or E
- •B. Eye meets eligibility criteria for eye populations C,D or E
- •C. Eye meets eligibility criteria for eye populations D or E
- •E. Eye with abnormal corneal shape (except status post-keratorefractive surgery)
结局指标
主要结局
Precision and Agreement 2
时间窗: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 4
时间窗: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (6mm zone) of ANTERION and the reference device
Precision and Agreement 5
时间窗: 1 day
Reproducibility, repeatability and agreement of Cornea Thickness (µm) of ANTERION and the reference device
Precision and Agreement 1
时间窗: 1 day
Reproducibility, repeatability and agreement of Anterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 6
时间窗: 1 day
Reproducibility, repeatability and agreement of Lens Thickness, ACD, Pupil Diameter, White-to-White, Axial Length (mm) of ANTERION and the reference device
Precision and Agreement 3
时间窗: 1 day
Reproducibility, repeatability and agreement of Posterior Corneal Topography parameters (3mm ring) of ANTERION and the reference device
Precision and Agreement 7
时间窗: 1 day
Reproducibility, repeatability and agreement of Anterior Chamber Volume (mm\^3) of ANTERION and the reference device
次要结局
- Adverse Events Rate(1 day)