A Comparative Analysis of the Diagnostic Outcomes of Artificial Intelligence-assisted Fundus Photography for Diabetic Retinopathy and Diabetic Macular Edema Versus Other Imaging Devices in Ophthalmology: A Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The accuracy
研究概览
简要总结
This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.
详细描述
This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.
This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes;
- •Obtaining informed consent;
- •Patient age 18 or above.
排除标准
- •Patients under 18 years of age;
- •Failure to Obtain informed consent;
- •Presence of other retinal diseases;
- •A patient who has already undergone the treatment.
结局指标
主要结局
The accuracy
时间窗: Baseline-Month 12
Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography
次要结局
- The accuracy(Baseline-Month 12)
研究者
Wu Hongkang
Director
Second Affiliated Hospital, School of Medicine, Zhejiang University