NCT06269666已完成不适用
P200TxE Diseased Eye Image Collection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Optos, PLC
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of images
研究概览
简要总结
The primary objective is to collect images on the P200TxE device in diseased eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;
- •Subjects who can follow the instructions by the clinical staff at the clinical site;
- •Subjects who agree to participate;
- •Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.
- •For glaucoma subjects:
- •a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.
排除标准
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with ocular media not sufficiently clear to obtain acceptable images.
研究组 & 干预措施
Imaging Session
Other
Various scans will be captured
干预措施: P200TxE (Device)
结局指标
主要结局
Number of images
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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