Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
NCT ID: NCT04612868
Last Updated: 2023-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
531 participants
INTERVENTIONAL
2020-10-16
2021-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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AEYE Software Device
An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.
AEYE Software Device
Eligible participants will undergo the following procedures:
* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.
* Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.
* All study subjects will have their pupils dilated using dilation drops.
Interventions
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AEYE Software Device
Eligible participants will undergo the following procedures:
* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.
* Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.
* All study subjects will have their pupils dilated using dilation drops.
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO).
* Understand the study and volunteer to sign the informed consent
Exclusion Criteria
* Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
* History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
* Currently participating in another investigational eye study and actively receiving investigational product for Diabetic Retinopathy (DR) or Diabetic Macular Edema (DME).
* Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
* Participant is contraindicated for imaging by fundus imaging systems used in the study:
1. Participant is hypersensitive to light
2. Participant recently underwent photodynamic therapy (PDT)
3. Participant is taking medication that causes photosensitivity
4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
22 Years
ALL
No
Sponsors
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AEYE Health Inc
INDUSTRY
Responsible Party
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Locations
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The Eye Care Institute
Louisville, Kentucky, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AEYE-DS-001
Identifier Type: -
Identifier Source: org_study_id
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