Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 840
- 试验地点
- 2
- 主要终点
- Sensitivity, specificity, kappa coefficient
研究概览
简要总结
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.
详细描述
Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists.
The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients defined by WHO criteria
- •lived in the geographic area of participated hospitals
排除标准
- •have contraindications for receiving mydriatic medications
- •have ocular media not clear enough for making diagnosis by any of the screening equipment
- •have other retina diseases precluded the diagnosis of diabetic retinopathy
结局指标
主要结局
Sensitivity, specificity, kappa coefficient
时间窗: cross-sectional
次要结局
未报告次要终点
