Actively Recruiting
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings
Led by iHealthScreen Inc · Updated on 2025-08-28
1076
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating iPredict, an automated AI-based system designed for early diagnosis and prediction of late age-related macular degeneration (AMD) in primary care and ophthalmology settings. This study aims to validate the system's accuracy compared to ophthalmologist diagnosis, using prospectively taken OCT images and color fundus photos. AMD affects millions and can lead to blindness and related complications, highlighting the need for large-scale screening tools like iPredict. Participants will have non-dilated photos of their eyes taken at their primary care doctor's or ophthalmologist's office using an FDA-approved fundus camera (DRSPlus). These images are securely transmitted and analyzed in the cloud using telemedicine features. The study involves one cohort with no direct intervention; the focus is on evaluating the performance of the automated screening software. During the study, participants will attend clinic visits for eye photography and related procedures. Researchers will assess the accuracy of iPredict in identifying referable and non-referable AMD and predicting AMD incidence within one to two years. Participants may be monitored over this period to track AMD progression, with study-related procedures provided at no cost.
CONDITIONS
Brief 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 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year or 2 years
Participants have non-dilated photos of their eyes taken at their primary care or ophthalmologist office to evaluate for early signs of age-related macular degeneration using an automated AI-based system.
1 to 2 visits depending on cohort assignment
Duration - Up to 2 years
Participants are monitored over time to predict the progression to late age-related macular degeneration based on imaging and AI analysis results.
Follow-up visits as scheduled during monitoring period
Trial Site Locations
Total: 1 location
1
iHealthScreen Inc.
Richmond Hill, New York, United States, 11418
Actively Recruiting
Research Team
A
Alauddin Bhuiyan
F
Fariha Nuha, BS (Comp. Biology)
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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