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临床试验/NCT03903042
NCT03903042Unknown不适用

Comparison of Aurora Fundus Camera With Traditional Fundus Camera in Diabetic Retinopathy With Phoebus Visual Artificial Intelligence

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Image Quality of Aurora camera

研究概览

简要总结

This study aims to compare the effect of Aurora handheld fundus camera with traditional desktop fundus camera in the fundus photography screening of diabetic patients, and to evaluate the effect of artificial intelligence algorithm in the diagnosis of diabetic retinopathy.

详细描述

Aurora handheld fundus cameras are used to take fundus photography on diabetic patients in 3 ophthalmic diabetic retinopathy screening centers in China to compare its effect with the hospital's traditional desktop fundus camera, and evaluate the auxiliary diagnostic effect of Phoebus artificial intelligence algorithm in diabetic retinopathy.

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

入选标准

  • Participants are more than 18 years of age, male or female Chinese patients;
  • Diagnosed with diabetes;
  • Prior written informed consent should be obtained

排除标准

  • Patients with invisible fundus caused by any cause;
  • Patients or his/her licensor unwill to sign an informed consent or follow this protocol;
  • Pregnant women

结局指标

主要结局

Image Quality of Aurora camera

时间窗: within 3 months

Score of Image Quality

次要结局

  • Image of traditional camera (Center 2: Zeiss)(1 month)
  • Outcome of gold standard(within 3 months)
  • Image of Aurora camera(1 month)
  • Outcome of artificial intelligence algorithm(3 months)
  • Image of traditional camera (Center 1: Canon)(1 month)
  • Image of traditional camera (Center 3: Topcon)(1 month)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fenghua Wang

Doctoral Investigator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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