Clinical Trial Network | Houston, TX
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About
The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy (mtmDR) in adult participants diagnosed with Diabetic Mellitus (DM) using fundoscopic images of the eyes. The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy (mtmDR) in patients with known diabetes using digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye.
Participants:
The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female, Age≥22
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
Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
Previously diagnosed with Diabetic Retinopathy.
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 DR or Diabetic Macular Edema (DME).
Subject 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).
Subject is contraindicated for imaging by fundus imaging systems used in the study:
Subject is pregnant
Primary purpose
Allocation
Interventional model
Masking
575 participants in 1 patient group
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Central trial contact
Ahava Stein
Data sourced from clinicaltrials.gov
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