Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Agreement in identification of abnormalities of the acquired Standard OCT images between the devices
研究概览
简要总结
This is a prospective clinical study conducted at one clinical site in the United States.
详细描述
The conducted study is an observational study for an imaging device used in the aid of ophthalmology diagnosis.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Agreement in identification of abnormalities of the acquired Standard OCT images between the devices
时间窗: through study completion, average of 1 day
based on pre-specified abnormalities
Agreement in identification of abnormalities of the acquired OCTA images between the devices
时间窗: through study completion, average of 1 day
based on pre-specified abnormalities
The image quality grade of the acquired images as determined by an independent reading center
时间窗: through study completion, average of 1 day
OCT, OCTA and IR cSLO - graded Good (2)/Average (1)/Poor (0)
次要结局
- Adverse events(through study completion, average of 1 day)