Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Accuracy of AI Grade
研究概览
简要总结
A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to sign and date the informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age (≥)21 years of age or older
- •Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)
- •Hemoglobin A1c (HbA1c) ≥ 6.5%
- •Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
- •Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
排除标准
- •Persistent visual impairment in one or both eyes;
- •History of macular edema or retinal vascular (vein or artery) occlusion;
- •History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- •Subject is contraindicated for fundus photography (for example, has light sensitivity);
- •Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- •Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or
- •Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs
- •Subject falls into one of the below categories:
- •Adults unable to consent (individuals w/ impaired decision-making capacity)
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Accuracy of AI Grade
时间窗: From time of arrival to completion of diagnostic tests, up to 8 hours
AI generated image grades are directly compared to a Human generated image grade
次要结局
未报告次要终点