A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
NCT ID: NCT04160988
Last Updated: 2021-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
703 participants
OBSERVATIONAL
2019-12-16
2020-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Subject with age ≥ 20 years old
2. Subject with documented diagnosis of diabetes mellitus
3. Subject with image taken by color fundus photography that meet the following requirement:
* The resolution of image is 1024×1024 pixels or higher;
* The angle view of image is 45 or 50 degree.
4. Subject's image includes macula and optic nerve as judged by the ophthalmologist.
Exclusion Criteria
1. The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
2. The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Acer Being Health Inc.
INDUSTRY
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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QCR19002
Identifier Type: -
Identifier Source: org_study_id
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