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NCT05857943 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by AEYE Health.

Completed
Registry status
NA
Development phase
363
Enrollment target

NCT05857943: Completed NA study, sponsored by AEYE Health.

NCT05857943 is a NA study that has completed, run by AEYE Health. The registered enrollment target is 363 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05857943, a NA study, has completed, sponsored by AEYE Health.

COMPLETED
Registry status
NA
Development phase
363 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 funduscopic images using 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-DS Software

Trial Details

FieldValue
Enrollment Target 363 participants
Start Date 2023-03-29
Est. Completion 2023-10-10
Phase NA
AEYE Health

3 total trials

What the finished NCT05857943 record still lists

NCT05857943 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

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

NCT05857943 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05857943 about?

NCT05857943 is a clinical study titled "Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic 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 funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at ...

What is the current status of trial NCT05857943?

This trial is currently completed. It is a NA study. The enrollment target is 363 participants. The study started on 2023-03-29. Estimated completion is 2023-10-10.

What interventions are being tested in trial NCT05857943?

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

Who is sponsoring clinical trial NCT05857943?

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

How this trial's enrollment target compares

Where NCT05857943's enrollment target sits among peer trials

363 284th of 2000 higher than 1,717 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05857943, the US trial registry maintained by the National Library of Medicine. NCT05857943 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.