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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
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• Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent

Locations
United States
New York
iHealthScreen Inc.
RECRUITING
Richmond Hill
Contact Information
Primary
Alauddin Bhuiyan
bhuiyan@ihealthscreen.org
718-926-9000
Backup
Fariha Nuha, BS (Comp. Biology)
fariha@ihealthscreen.org
718-912-0837
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 1076
Treatments
One group
One Cohort
Sponsors
Leads: iHealthScreen Inc
Collaborators: National Institutes of Health (NIH), National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov