Study to Test an AI System for Early Detection and Prediction of Advanced Age-related Macular Degeneration in Eye Care Settings

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 systems 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 doctors or ophthalmologists 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.

Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration