NCT04567745已完成1 期
Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- retinopathy features identification
研究概览
简要总结
This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).
排除标准
- •Children and subjects with other diagnoses than those mentioned in the inclusion criteria.
- •Patients without the means to visit the clinic on the assigned dates.
- •Patients who are pregnant or are expecting to become pregnant.
研究组 & 干预措施
Cognitive diagnosis
Other
干预措施: Retinal fundus photography (Diagnostic Test)
结局指标
主要结局
retinopathy features identification
时间窗: 12 months
The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations
次要结局
未报告次要终点
研究者
Oana M. Dumitrascu
Principal Investigator
Mayo Clinic
研究点 (1)
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