NCT03572699Unknown不适用
Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy
研究概览
简要总结
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 or type 2 diabetes mellitus
- •Ages 18 and above
- •Male and female
排除标准
- •Persistent visual impairment in one or both eyes;
- •Subjects with corneal opacities and advanced cataract.
- •History of retinal vascular (vein or artery) occlusion;
- •Subject is contraindicated for fundus photography (for example, has light sensitivity);
- •Subject is currently enrolled in an interventional study of an investigational device or drug;
- •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.
结局指标
主要结局
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy
时间窗: 3 months
次要结局
- Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater)(3 months)
- Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater)(3 months)
研究者
Dr Srikanth Y N
Principal investigator
Medios Technologies Pte. Ltd
研究点 (1)
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