NCT03578302已完成不适用
The Heidelberg Engineering BI US Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of successfully scanned biometry images of the eye
研究概览
简要总结
Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI
详细描述
The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •At least one of the following:
- •Eyes with Normal Anterior Segment
- •Eyes with Cataract
- •Eyes without a Crystalline Lens
- •Eyes with Corneal Abnormality
- •Eyes with Anterior Segment Pathology
排除标准
- •Subjects unable to read or write
- •Active infection or inflammation in one or both eyes
- •Insufficient tear film or corneal reflex
- •Physical inability to be properly positioned at the study devices or eye exam equipment
- •Inability to fixate
- •Rigid contact lens wear during past 2 weeks
- •Soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements *Note: Eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study
结局指标
主要结局
Percentage of successfully scanned biometry images of the eye
时间窗: 1 day
Percentage of successfully scanned biometry images of the eyes per scan mode. Success is defined as agreement of the subjective assessment of the operator and the auto assessment of the device.
Repeatabiltiy of specific parameters of the biometry images of the eye
时间窗: 1 day
Repeatability of specific parameters stratified by different eye pathologies
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06762340[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04616833[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04945941[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06733259[Redacted]
已完成
不适用
Clinical Investigation (Beta) of a New Developed Prosthetic KneeNCT06748729Össur Iceland ehf11