RECRUITING

PROTOCOL TITLE: 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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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

Quick Facts

Study Start:2024-08-01
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07084883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
  1. * Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.

Contacts and Locations

Study Contact

Alauddin Bhuiyan
CONTACT
718-926-9000
bhuiyan@ihealthscreen.org

Study Locations (Sites)

iHealthScreen Inc.
Richmond Hill, New York, 11418
United States

Collaborators and Investigators

Sponsor: iHealthScreen Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Screening
  • Prediction

Additional Relevant MeSH Terms

  • Age-Related Macular Degeneration (AMD)