Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration

Part of paid clinical trials in Richmond Hill, New York.

Sponsor
iHealthScreen Inc
Study ID
NCT07084883
Status
Recruiting
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Conditions

  • Age-related Macular Degeneration (AMD)

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • No intervention. — DEVICE
    No intervention. Evaluate the automated AMD screening software.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
1,076 participants (estimated)

Arms

  • Arm: One group
    One Cohort

Primary Outcome Measure

Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year. [ Time Frame: 1 year or 2-year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
iHealthScreen Inc.Richmond HillNew York11418
Alauddin Bhuiyan
[email protected]
718-926-9000

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By research site
iHealthScreen Inc.· Richmond Hill, NY

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