NCT05286502已完成不适用
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- fundus photo image quality
研究概览
简要总结
Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are 18 years of age or older on the date of informed consent.
- •Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.
排除标准
- •Subjects who are unable to tolerate ophthalmic imaging.
- •Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
- •Subjects who cannot follow instructions to complete the required testing.
结局指标
主要结局
fundus photo image quality
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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