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

iHealthScreen Inc · with National Institutes of Health (NIH), National Eye Institute (NEI) · NCT07084883

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1076
US sites recruiting
1
Study start
August 1, 2024
Record last updated
August 28, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: No intervention.

Conditions: Age-related Macular Degeneration (AMD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • iHealthScreen Inc.

    Richmond Hill, NY 11418

    Site contact: Alauddin Bhuiyan · 718-926-9000 · bhuiyan@ihealthscreen.org

Study contacts (from the official record)

  • Alauddin Bhuiyan · 718-926-9000 · bhuiyan@ihealthscreen.org
  • Fariha Nuha, BS (Comp. Biology) · 718-912-0837 · fariha@ihealthscreen.org
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Pivotal Trial of an Automated AI-based System for Early Diagnosis… (NCT07084883) | Bored Studies