NCT03964831已完成不适用
Visualization Study of the UWF (Ultra Wide-field) SLO (Scanning Laser Ophthalmoscope) RG (Red Green), AF (Autofluorescence), FA (Fluorescein Angiography) and ICG ( Indocyanine Green Fluorescence) Images Using the P200TxE (Indy) and P200DTx (California)
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
- 40
- 试验地点
- 1
- 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 (1)
Loading locations...
相似试验
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT02474784[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06323005[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT01988025[Redacted]
已完成
不适用
Evaluation of a New Noise Reduction Strategy in Hearing AidsHearing LossNCT06138665Sonova AG17
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT02495116[Redacted]