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
iHealthScreen Inc
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.
Description
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 establ…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- DeviceNo intervention.
No intervention. Evaluate the automated AMD screening software.
Location
- iHealthScreen Inc.Richmond Hill, New York