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

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03903042
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image Quality of Aurora camera	within 3 months	Score of Image Quality

Secondary Outcome Measures

Name	Time	Method
Image of Aurora camera	1 month	Images taken by Aurora camera
Outcome of gold standard	within 3 months	Gold standard: 8 photographs of one patient(4 by Aurora camera, 4 by traditional camera) by ophthalmologist（double blinded）
Image of traditional camera (Center 1: Canon)	1 month	Image taken by traditional camera（Center 1: Canon, pupil not dilated）
Image of traditional camera (Center 2: Zeiss)	1 month	Image taken by traditional camera（Center 2: Zeiss, pupil dilated）
Outcome of artificial intelligence algorithm	3 months	Outcome of artificial intelligence algorithm(Normal or Referral Required)
Image of traditional camera (Center 3: Topcon)	1 month	Image taken by traditional camera（Center 3: Topcon, pupil dilated）

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China