Status:
RECRUITING
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Lead Sponsor:
iHealthScreen Inc
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Diabetes
Diabetic Retinopathy
Eligibility:
All Genders
22+ years
Brief Summary
In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in...
Detailed Description
In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in...
Eligibility Criteria
Inclusion
- Age of Subjects: Patients ≥ 22 years of age.
- Gender of Subjects: Both males and females will be invited to participate.
- Subjects with diabetes (A1C level ≥ 6.5).
- Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.
Exclusion
- Unable to understand the study, Our unable to or unwilling to sign the informed consent
- Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider
- subjects whose retinal images were used in training, validating, or developing the device
- Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.
- A condition that, in the opinion of the investigator, would preclude participation in the study;
- Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
922 Patients enrolled
Trial Details
Trial ID
NCT07151001
Start Date
January 1 2025
End Date
July 31 2027
Last Update
September 2 2025
Active Locations (1)
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1
iHealthScreen Inc.
Richmond Hill, New York, United States, 11418