Investigation of the Accuracy of a Self-testing Diagnosis Imaging Model for Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Accuracy in the diagnosis of referral retinal lesions
研究概览
简要总结
This is a prospective clinical study. At the Shaoguan Diabetic Eye Screening Programme, patients ages 30-80 will undergo the two diagnostic models: (1) in a remote diagnostic clinic site, patients undergo a self-testing device that provides both color retinal photography (CRP) and optical coherence tomography (OCT) imaging of nondilated pupils, and receive an online consultation provided by a retinal specialist; (2) on a separate day, patients visit the tertiary hospital, undergo traditional imaging of dilated pupils acquired by a non-expert imager using a traditional CRP imaging device at the point of care, and receive a face-to-face consultation provided by a retinal specialist.
Within one week of receiving both diagnostic imaging services, patient preferences are assessed and they decide which diagnostic imaging model is preferred.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who are enrolled in the Shaoguan Diabetic Eye Screening Programme for their eye check-up
- •who are diagnosed with diabetes and aged between 30 years and 80 years
- •be able to sit for an imaging device for image acquisition
- •be capable of giving their own consent
排除标准
- •who are pregnant or nursing women
结局指标
主要结局
Accuracy in the diagnosis of referral retinal lesions
时间窗: 1 week
Accuracy in the diagnosis of referral retinal lesions using the self-testing diagnosis imaging
次要结局
- Satisfaction of participants as measured by questionnaire(1 week)
- The agreement between the two modalities(1 week)
- Feasibility of self-testing diagnosis imaging model(1 week)