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临床试验/NCT00500097
NCT00500097已完成不适用

Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training

Ministry of Health, Thailand2 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2005年5月1日最近更新:
适应症

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

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

研究者

发起方
Ministry of Health, Thailand
申办方类型
Other Gov

研究点 (2)

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