Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
This prospective multicenter study will evaluate the efficacy of a real-time artificial intelligence system for detecting multiple ocular fundus lesions by ultra-widefield fundus imaging in real-world settings.
详细描述
The ocular fundus can show signs of both ocular diseases (e.g., lattice degeneration, retinal detachment and glaucoma) and systemic diseases (e.g., hypertension, diabetes and leukemia). The routine fundus examination is conducive for early detection of these diseases. However, manual conducting fundus examination needs an experienced retina ophthalmologist, and is time-consuming and labor-intensive, which is difficult for its routine implementation on large scale.
This study will develop an artificial intelligence system integrating with ultra-widefield fundus imaging to automatically screen for multiple ocular fundus lesions in real time and evaluate its performance in different real-world settings. The efficacy of the system will compare to the final diagnoses of each participant made by experienced ophthalmologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the participants who agree to take ultra-widefield fundus images.
排除标准
- •Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
- •Patients who do not agree to sign informed consent.
结局指标
主要结局
Accuracy
时间窗: 8 months
Performance of artificial intelligence system for detecting multiple ocular fundus lesions based on ultra-widefield fundus imaging.
次要结局
- False-positive rate(8 months)
- Sensitivity(8 months)
- Cohen's kappa coefficient(8 months)
- Specificity(8 months)
- False-negative rate(8 months)
- Data processing time of AI system(8 months)
研究者
Haotian Lin
Professor
Sun Yat-sen University