NCT03964831Withheld不适用
[Trial of device that is not approved or cleared by the U.S. FDA]
[Redacted]2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Withheld
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Qualitative Image assessment
研究概览
简要总结
The study evaluates image quality between two devices.
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 volunteer 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 in the study;
- •Subjects diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;
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
Ultra widefield image capture
Other
干预措施: P200TxE (Device)
Ultra widefield image capture
Other
干预措施: P200DTx (Device)
结局指标
主要结局
Qualitative Image assessment
时间窗: 6 months
Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).
Safety Assessment from Adverse Events
时间窗: 6 months
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.
次要结局
未报告次要终点
研究者
研究点 (2)
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