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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed willing to sign a consent form Who Should NOT Join This Trial: - Already diagnosed with AMD, unable to provide willing to sign a consent form and currently under treatment of retinal disease. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

No intervention.

No intervention. Evaluate the automated AMD screening software.

Locations (1)

iHealthScreen Inc.
Richmond Hill, New York, United States