The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Corneal Epithelial Thickness 0-2mm ring
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 corneal epithelial thickness parameters with the ANTERION
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Subjects ≥ 22 years of age
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •Able to fixate
- •With at least one of the following eye status for the corresponding eye population:
- •Normal Cornea
- •Abnormal Cornea: eye with at least one of the following
- •a) Keratoconus b) Contact Lens Wearer c) Status Post-Keratorefractive Surgery (at least 30 days between imaging and Keratorefractive Surgery) d) Dry Eye Disease
排除标准
- •Exclusion Criteria General
- •Active infection in either eye
- •Insufficient corneal reflex, in the study eye
- •Physical inability to be properly positioned at the study devices or eye exam equipment
- •Exclusion Criteria Normal Cornea Group
- •Abnormal cornea shape or corneal surgery in the study eye
- •Contact lens wear within 3 months prior to imaging in the study eye
- •Dry eye disease in the study eye
- •Exclusion Criteria Abnormal Cornea Group
- •For Keratoconus (a):
- •Contact lenses worn within one hour prior to imaging
- •For Contact Lens Wearer (b):
- •Keratoconus
- •Post-Keratorefractive surgery
- •Contact lenses worn within one hour prior to imaging
- •For Post-Keratorefractive Surgery (c):
- •Keratoconus
- •Contact lens wear within 3 months prior to imaging in the study eye
- •For Dry Eye Disease (d):
- •Keratoconus
- •Post-Keratorefractive surgery
- •Contact lens wear within 3 months prior to imaging in the study eye
结局指标
主要结局
Corneal Epithelial Thickness 0-2mm ring
时间窗: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (0-2mm ring) of ANTERION and the reference device
Corneal Epithelial Thickness 2-5mm ring
时间窗: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Corneal Epithelial Thickness 5-7mm ring
时间窗: Through study completion, an average of 1 day
Reproducibility, repeatability and agreement of Corneal Epithelial Thickness parameters (2-5mm ring) of ANTERION and the reference device
Minimum Thickness from 7mm zone
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of minimum thickness (7mm zone) of ANTERION and the reference device
Maximum Thickness from 7mm zone
时间窗: Through study completion, an average of 1 day
Reproducibility and repeatability of maximum thickness (7mm zone) of ANTERION and the reference device
次要结局
- Adverse Events Rate(Through study completion, an average of 1 day)