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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: Recruiting study of Age-related Macular Degeneration (AMD), sponsored by iHealthScreen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Conditions Studied
Interventions
- DEVICE No intervention.
Study Locations (1)
New York
- iHealthScreen Inc. - Richmond Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,076 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-07-31 |
What NCT07084883 shows while recruiting
NCT07084883 is an observational study that tracks outcomes without assigning an intervention. Its 1,076 participants enrollment target places it among the larger protocols in the corpus, below the 101,769-participant average among 7 other Age-related Macular Degeneration (AMD) trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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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