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NCT07084883 · ClinicalTrials.gov registry record

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

A clinical trial of Age-related Macular Degeneration (AMD), sponsored by iHealthScreen.

Recruiting
Registry status
1,076
Enrollment target
1
Study location

NCT07084883 is a study of Age-related Macular Degeneration (AMD) that is actively recruiting participants, run by iHealthScreen. The registered enrollment target is 1,076 participants, below the 101,769-participant average among 7 other Age-related Macular Degeneration (AMD) trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07084883, a study of Age-related Macular Degeneration (AMD), is actively recruiting participants, sponsored by iHealthScreen.

RECRUITING
Registry status
1,076 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DEVICE No intervention.

Study Locations (1)

New York

  • iHealthScreen Inc. - Richmond Hill

Trial Details

FieldValue
Enrollment Target 1,076 participants
Start Date 2024-08-01
Est. Completion 2027-07-31

Sponsor

iHealthScreen

2 total trials

What the Registry Record Tells You About NCT07084883

The ClinicalTrials.gov registry entry for NCT07084883 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,076 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 101,769-participant average among 7 other Age-related Macular Degeneration (AMD) trials with a reported enrollment target (99% lower). The listed sponsor is iHealthScreen, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Age-related Macular Degeneration (AMD) appearing as the primary indexed condition, and to 1 intervention - of which No intervention. is the first listed.

NCT07084883 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT07084883 about?

NCT07084883 is a clinical study titled "Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration". 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 FD...

What is the current status of trial NCT07084883?

This trial is currently recruiting. The enrollment target is 1,076 participants. The study started on 2024-08-01. Estimated completion is 2027-07-31.

What conditions does trial NCT07084883 study?

This clinical trial studies the following conditions: Age-related Macular Degeneration (AMD).

What interventions are being tested in trial NCT07084883?

The interventions under investigation include: No intervention. (DEVICE).

Who is sponsoring clinical trial NCT07084883?

This trial is sponsored by iHealthScreen, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07084883 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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