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NCT04612868 · ClinicalTrials.gov registry record · NA

Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images

A NA study, sponsored by AEYE Health.

Completed
Registry status
NA
Development phase
531
Enrollment target

NCT04612868 is a NA study that has completed, run by AEYE Health. The registered enrollment target is 531 participants.

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The verdict

NCT04612868, a NA study, has completed, sponsored by AEYE Health.

COMPLETED
Registry status
NA
Development phase
531 participants
Enrollment target

Study Summary

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (AI)-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.

Interventions

  • DEVICE AEYE Software Device

Trial Details

FieldValue
Enrollment Target 531 participants
Start Date 2020-10-16
Est. Completion 2021-12-26
Phase NA

Sponsor

AEYE Health

3 total trials

What the Registry Record Tells You About NCT04612868

The ClinicalTrials.gov registry entry for NCT04612868 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 531 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AEYE Health, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AEYE Software Device is the first listed.

NCT04612868 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04612868 about?

NCT04612868 is a clinical study titled "Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images". AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (AI)-based software. This study has been designed to validate the safety and effic...

What is the current status of trial NCT04612868?

This trial is currently completed. It is a NA study. The enrollment target is 531 participants. The study started on 2020-10-16. Estimated completion is 2021-12-26.

What interventions are being tested in trial NCT04612868?

The interventions under investigation include: AEYE Software Device (DEVICE).

Who is sponsoring clinical trial NCT04612868?

This trial is sponsored by AEYE Health, which has 3 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.