Actively Recruiting
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Led by iHealthScreen Inc · Updated on 2025-08-28
1076
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
iHealthScreen Inc
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.
CONDITIONS
Official Title
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to comply with clinic visits and study-related procedures
- Able to provide signed informed consent
You will not qualify if you...
- Already diagnosed with Age-related Macular Degeneration (AMD)
- Unable to provide informed consent
- Currently under treatment for retinal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
iHealthScreen Inc.
Richmond Hill, New York, United States, 11418
Actively Recruiting
Research Team
A
Alauddin Bhuiyan
CONTACT
F
Fariha Nuha, BS (Comp. Biology)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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