UNITY DX Cornea Precision and Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mean corneal thickness
研究概览
简要总结
The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of corneal and epithelial thickness maps will be evaluated.
详细描述
The study population will consist of male and female adult subjects with normal corneas (approximately 30 subjects), keratoconus (approximately 20 subjects), prior corneal laser vision correction (approximately 20 subjects), current and habitual contact lens wear (approximately 20 subjects), and dry eye (approximately 20 subjects). In this single visit study, measurements will be taken by 3 different operators using their own set of devices (configuration), UNITY DX and ANTERION. Each subject's participation is expected to last approximately 3 hours with a planned duration of exposure generally not longer than 10 minutes per device. Only one eye (designated as the study eye) will be enrolled per subject.
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
- •Able to understand and sign an Institutional Review Board approved informed consent form.
- •Willing and able to attend all scheduled study visits as required per protocol.
- •Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
- •Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- •Active ocular infection or inflammation.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Normal Corneas
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with normal corneas.
干预措施: UNITY DX (Device)
Normal Corneas
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with normal corneas.
干预措施: ANTERION (Device)
Keratoconus
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with keratoconus.
干预措施: UNITY DX (Device)
Keratoconus
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with keratoconus.
干预措施: ANTERION (Device)
Prior Corneal Laser Vision Correction
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with prior corneal laser vision correction.
干预措施: UNITY DX (Device)
Prior Corneal Laser Vision Correction
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with prior corneal laser vision correction.
干预措施: ANTERION (Device)
Current and Habitual Contact Lens Wear
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with current and habitual contact lens wear.
干预措施: UNITY DX (Device)
Current and Habitual Contact Lens Wear
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with current and habitual contact lens wear.
干预措施: ANTERION (Device)
Dry Eye
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with dry eye.
干预措施: UNITY DX (Device)
Dry Eye
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans. This cohort will enroll subjects with dry eye.
干预措施: ANTERION (Device)
结局指标
主要结局
Mean corneal thickness
时间窗: Day 1
Corneal thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Mean epithelial thickness
时间窗: Day 1
Epithelial thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
次要结局
未报告次要终点