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This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.
This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.
This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| artificial intelligence-assisted fundus photography | Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy |
| |
| optical coherence tomography | optical coherence tomography in patients with diabetic retinopathy |
| |
| fundus fluorescence angiography | fundus fluorescence angiography in patients with diabetic retinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fundus photography | Diagnostic Test | using artificial intelligence to identify diabetic retinopathy using fundus photography |
|
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy | Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography | Baseline-Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy | Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography | Baseline-Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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It is planned to include 1,000 participants in the study, all of whom will undergo fundus photography, 500 additional patients will undergo fundus fluorescence angiography, and 500 additional patients will undergo optical coherence tomography.
All participants met inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongkang Wu, MMS | Contact | +8618969978676 | wuhongkang@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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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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| ID | Term |
|---|---|
| D005451 | Fluorescein Angiography |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| optical coherence tomography | Diagnostic Test | detect diabetic retinopathy and diabetic macular edema by optical coherence tomography |
|
| fundus fluorescence angiography | Diagnostic Test | detect diabetic retinopathy by fundus fluorescence angiography |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D014054 | Tomography |
| D008919 | Investigative Techniques |