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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Center 1: Traditional camera(Canon) vs Aurora camera | ||
| Group 2 | Center 2: Traditional camera(Zeiss) vs Aurora camera | ||
| Group 3 | Center 3: Traditional camera(Topcon) vs Aurora camera |
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| Measure | Description | Time Frame |
|---|---|---|
| Image Quality of Aurora camera | Score of Image Quality | within 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were diagnosed with diabetes, more than 18 years of age, male or female Chinese patients.
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| Name | Affiliation | Role |
|---|---|---|
| Fenghua Wang | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30357401 | Background | Jin G, Xiao W, Ding X, Xu X, An L, Congdon N, Zhao J, He M. Prevalence of and Risk Factors for Diabetic Retinopathy in a Rural Chinese Population: The Yangxi Eye Study. Invest Ophthalmol Vis Sci. 2018 Oct 1;59(12):5067-5073. doi: 10.1167/iovs.18-24280. | |
| 30393210 | Background | Zheng X, Zhang L. A study of retinopathy analysis in type 2 diabetes patients in Chinese population. Pak J Pharm Sci. 2018 Sep;31(5(Supplementary)):2041-2046. |
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Clinical Study Report will be published
starting 6 months after publication
Dr Fenghua Wang will review requests and criteria.
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| 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 |
| 26319349 | Background | Hendrick AM, Gibson MV, Kulshreshtha A. Diabetic Retinopathy. Prim Care. 2015 Sep;42(3):451-64. doi: 10.1016/j.pop.2015.05.005. |
| 27898977 | Background | Wong TY, Bressler NM. Artificial Intelligence With Deep Learning Technology Looks Into Diabetic Retinopathy Screening. JAMA. 2016 Dec 13;316(22):2366-2367. doi: 10.1001/jama.2016.17563. No abstract available. |
| 20214432 | Background | Abramoff MD, Niemeijer M, Russell SR. Automated detection of diabetic retinopathy: barriers to translation into clinical practice. Expert Rev Med Devices. 2010 Mar;7(2):287-96. doi: 10.1586/erd.09.76. |
| 30275284 | Background | Li Z, Keel S, Liu C, He Y, Meng W, Scheetz J, Lee PY, Shaw J, Ting D, Wong TY, Taylor H, Chang R, He M. An Automated Grading System for Detection of Vision-Threatening Referable Diabetic Retinopathy on the Basis of Color Fundus Photographs. Diabetes Care. 2018 Dec;41(12):2509-2516. doi: 10.2337/dc18-0147. Epub 2018 Oct 1. |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |