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Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
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
Who can join
Ages 50 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent Exclusion Criteria: * Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.
About the study
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.
What is being tested
- No intervention. (device)
Sponsor: iHealthScreen Inc · Participants: 1,076 · Started: Aug 1, 2024
Contact the study team
- Alauddin Bhuiyan · Phone: 718-926-9000
- Fariha Nuha, BS (Comp. Biology) · Phone: 718-912-0837
Official record on ClinicalTrials.gov — NCT07084883
Locations in the U.S.
| New York | iHealthScreen Inc., Richmond Hill |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.