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临床试验/NCT01832077
NCT01832077已完成不适用

The Impact of Telemedicine System to the Diagnosis and Treatment of Diabetes Retinopathy in Rural Canton

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
1
主要终点
cost-effectiveness

研究概览

简要总结

To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment of Diabetes retinopathy and Diabetes macular edema.

详细描述

Telemedicine system mainly contains a comprehensive eye examination electric-records (E-record), which can transfer the fundus pictures from rural hospitals to professional Graders (golden standard for a diagnose of Diabetes Retinopathy (DR) and Diabetes Macular Edema(DME)). In Zhongshan Ophthalmic Center (ZOC). By this system, the investigators can evaluate the capacity of rural eye doctors about the diagnosis of DR/DME, and give proper suggestions for the treatment and revisit plan.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 40y, diagnosed (Diabetes Retinopathy) DR,10% normal patients

排除标准

  • unconsciousness, history of diabetic ketoacidosis, cardiac insufficiency, Severe atrioventricular block, hepatic insufficiency , allergic to mydriatic

结局指标

主要结局

cost-effectiveness

时间窗: 2 years

Cost-effectiveness of three methods of DR screening (trained rural doctors versus telemedicine versus automated grading)

Accuracy of trained doctors in diagnosing DR/DME versus photo grading and automated grading

时间窗: 2 years after the telemedicine begin to use

To compare the sensitivity, specificity and positive and negative predictive value for a diagnosis of DR/DME , a diagnosis of DR/DME requiring treatment, of trained rural doctors and an automated grading system, as compared to trained graders using photographs (the gold standard)

次要结局

  • Frequency of comprehensive eye examination taken by rural doctors(2 years)
  • comprehensive eye examination rate among patients in rural hospitals(2 years)
  • the usage rate of Electric-Record(2 years)
  • Cost-effectiveness of van(2 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Congdon Nathan

vice director,Blindness Prevention and Treatment Department

Sun Yat-sen University

研究点 (1)

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