Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,034
- 试验地点
- 3
- 主要终点
- Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
研究概览
简要总结
In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or female subjects who are at least 18 years old 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, and can attend examinations on the scheduled examination dates;
- •Subjects who have been diagnosed with Type I or Type II diabetes mellitus.
排除标准
- •Subjects unable to tolerate ophthalmic imaging;
- •Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
- •Subject blind in one eye due to any cause
- •Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
结局指标
主要结局
Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
时间窗: 3 months
To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists
次要结局
- Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists(3 months)
- Number of subjects with gradable images taken by the hand held camera(3 months)