Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images
Study Details
Study Description
Brief Summary
AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AEYE-DS 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 |
Device: AEYE-DS Software
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 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.
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Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥22
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Male or female
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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:
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Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
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Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
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Previously diagnosed with Diabetic Retinopathy.
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History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
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Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
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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).
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Participant is contraindicated for imaging by fundus imaging systems used in the study:
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Participant is hypersensitive to light
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Participant recently underwent photodynamic therapy (PDT)
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Participant is taking medication that causes photosensitivity
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Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
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Subject is pregnant.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Karas Health Care | Fayetteville | Arkansas | United States | 72701 |
2 | Lake Nona Research | Orlando | Florida | United States | 32832 |
3 | The Jackson Clinic | Jackson | Tennessee | United States | 38305 |
Sponsors and Collaborators
- AEYE Health LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AEYE-DS-002