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临床试验/NCT02927561
NCT02927561已完成不适用

Automated Diagnostic Test for Diabetic Retinopathy in Brazilian Mass Screening

Retina Clinic, Sao Paulo, Brazil1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2015年6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
220
试验地点
1
主要终点
To compare the sensitivity and specificity of automated grading system versus human grading in detecting diabetic retinopathy

研究概览

简要总结

In Brazil 10% of the adult population has diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR). Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system. The automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders.

详细描述

In the South and Central America Region, an estimated 9.4% of the adult population (20-79 years) has diabetes in 2015, and Brazil is the first country in number of people with diabetes. Of these, 39.0% are undiagnosed, at risk for developing complications such as diabetic retinopathy (DR)(1).

The rising number of people with diabetes in the world has become a real challenge for the public health system to provide care for patients with DR and for people with diabetes at risk for this complication(2). A large proportion of patients with diabetes was inadequately controlled in Brazil, which may contribute to increased rates of diabetic complications (3).

The detection of any degree of DR may result in improved medical monitoring and optimization of risk factors, delaying the progression of the disease(4). In Brazil, the great demand in the public service causes delay in early diagnosis, worsening health status of patients with diabetic retinopathy and increasing the cost of their treatment.

Due to the increasing prevalence of diabetes and high percentage of patients with uncontrolled disease, cost-effective tools are needed with focused attention on diabetes prevention and management in the current health system.

Several studies have shown that systematic screening for DR is an effective way of prevention (5). Furthermore, the automatic retinopathy detection can enlarge the screening, reducing the workload and costs compared to manual image graders(6). There are no reports on automated DR detection in Brazilian population, especially in screening campaigns with large-scale diagnosis.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

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

入选标准

  • Adults ≥ 18 years with type 1 or 2 diabetes mellitus

排除标准

  • Previous cataract, trabeculectomy or vitrectomy
  • External ocular infections
  • Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
  • Pregnancy or breastfeeding.

结局指标

主要结局

To compare the sensitivity and specificity of automated grading system versus human grading in detecting diabetic retinopathy

时间窗: 6 months

The aim of this study is to determine the sensitivity and specificity of automated grading system in detecting diabetic retinopathy compared with human grading on the population of annual massive screening campaign for diabetes conducted in the Northeast of Brazil.

次要结局

未报告次要终点

研究者

发起方
Retina Clinic, Sao Paulo, Brazil
申办方类型
Other
责任方
Sponsor

研究点 (1)

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