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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Retinopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are more than 18 years of age, male or female Chinese patients; Diagnosed with diabetes; Prior written informed consent should be obtained Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Center 1: Traditional camera(Canon) vs Aurora camera | |
| Group 2<br>Center 2: Traditional camera(Zeiss) vs Aurora camera | |
| Group 3<br>Center 3: Traditional camera(Topcon) vs Aurora camera | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality of Aurora camera | Score of Image Quality | within 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aurora fundus camera, Artificial intelligence, Diabetic retinopathy