Agreement and Precision Study of UNITY® DX and a Comparator Biometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Central corneal thickness (CCT)
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 the biometric measurements will be evaluated.
详细描述
This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.
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 Institution Review Board approved Informed Consent form.
- •Willing and able to attend all scheduled study visits as required by the protocol.
- •Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.
排除标准
- •Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
- •Any ocular disease and/or condition that, in the investigator's clinical judgment, 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.
- •Rigid or contact lens wear during the previous two weeks prior to Screening.
结局指标
主要结局
Central corneal thickness (CCT)
时间窗: Day 1
Central corneal thickness will be measured in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Lens thickness (LT)
时间窗: Day 1
Lens thickness will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Anterior chamber depth (regression) (ACD-R)
时间窗: Day 1
Anterior chamber depth (the physical length from the anterior cornea to the anterior lens) will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
Axial length (regression) (AL-R)
时间窗: Day 1
Axial length (the distance between the back and front of the eye) will be measured in millimeters and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.
次要结局
- Anterior Chamber Depth Sum of Segments (ACD-SoS)(Day 1)
- Axial Length Sum of Segments (AL-SoS)(Day 1)