Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsoriHealthScreen Inc
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
Disqualifiers
Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.
Trial population
This study will be carried at the primary care and general ophthalmology clinic. The total number of patients to be recruited is 1076. Subjects will be recruited during their routine ophthalmology visit, and each subject will be identified by their ophthalmologist as appropriate to take part in the study. After a short verbal explanation, the ophthalmologist may ask the subject to take part in the study. Patients will be recruited without selection by eye diagnosis from the clinics. Both males and females will be invited to participate. Patients will be over 50 since AMD is overwhelmingly a disease of this population. It is anticipated that the subjects will be of all races and ethnic origins, in line with our diverse clinic populations in New York city. Provided that they fit the study criteria, all subjects are invited to participate. However, we aim to recruit the majority as white ethnicity as AMD is a disease for predominantly white ethnicity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention.
DeviceNo intervention. Evaluate the automated AMD screening software.
Treatment groups
1,076 Participants
are divided into 1 treatment groupGroup A: One group1 intervention
Trial outcomes
Primary outcomes
1
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Time frame
1 year or 2-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
iHealthScreen Inc
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov