A Multi-Site Precision Study to Validate the Performance of CLAiR AI Software in Identifying Elevated Atherosclerotic Cardiovascular Disease Risk From Retinal Images.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Overall inter-operator reproducibility of the CLAiR ASCVD risk classification
研究概览
简要总结
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus images. Participants underwent protocol-defined retinal imaging using Topcon NW400 and NW500 cameras. The study assessed agreement and consistency of device outputs across operators and imaging conditions. No medical management decisions were made based on device results.
详细描述
This prospective, multi-site precision study was designed to evaluate the analytical performance and reproducibility of the CLAiR AI software, a software as a medical device (SaMD) intended to identify individuals with elevated risk of atherosclerotic cardiovascular disease (ASCVD) using retinal fundus images.
Participants were enrolled at U.S. clinical sites and underwent protocol-defined retinal imaging procedures using Topcon NW400 and NW500 non-mydriatic fundus cameras. Imaging was performed under controlled conditions, including predefined operator sequencing and repeated image acquisition, to assess reproducibility across operators and devices.
The primary objective was to evaluate agreement of device outputs across repeated imaging sessions and camera models. Secondary objectives included assessment of intra- and inter-operator variability.
The device under investigation was not FDA cleared or approved at the time of the study and was evaluated under institutional review board (IRB) oversight as a non-significant risk (NSR) device study. No therapeutic interventions were administered, and no clinical management decisions were made based on device outputs.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed.
- •Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit.
排除标准
- •Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting.
- •Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity <20/400).
- •Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.
研究组 & 干预措施
CLAiR Imaging Cohort
Participants underwent protocol-defined retinal fundus imaging using Topcon NW400 and NW500 cameras. Images were analyzed using the investigational CLAiR artificial intelligence software to evaluate performance and reproducibility. No clinical management decisions were made based on device outputs.
干预措施: CLAiR Artificial Intelligence Software (Device)
结局指标
主要结局
Overall inter-operator reproducibility of the CLAiR ASCVD risk classification
时间窗: Single study visit (approximately 2 hours)
Inter-operator reproducibility will be assessed as the overall percent agreement between paired binary CLAiR outputs (Elevated Risk, Not Elevated Risk, or No Result) generated from retinal images acquired by different operators. Agreement will be calculated across all paired comparisons according to the predefined statistical analysis plan.
次要结局
未报告次要终点