NCT04003831已完成不适用
Navigated Peripheral OCT Imaging With the P200TxE
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
- 26
- 试验地点
- 1
- 主要终点
- Qualitative Assessment of OCT Clinical Utility
研究概览
简要总结
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
排除标准
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
研究组 & 干预措施
Optical Coherence Tomographer
Other
干预措施: Device: P200TxE (Device)
结局指标
主要结局
Qualitative Assessment of OCT Clinical Utility
时间窗: 1 year
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Qualitative Assessment of OCT Scan Quality
时间窗: 1 year
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
次要结局
- Safety Assessment from Adverse Events(1 year)
研究者
研究点 (1)
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