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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: Completed NA study, sponsored by AEYE Health.
NCT04612868 is a NA study that has completed, run by AEYE Health. The registered enrollment target is 531 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS
Interventions
- DEVICE AEYE Software Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2021-12-26 |
| Phase | NA |
What the finished NCT04612868 record still lists
NCT04612868 is an interventional study that assigns participants to a tested intervention. The registered 531 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 (62% lower).
The record links to 0 conditions, and to 1 intervention - of which AEYE Software Device is the first listed.
NCT04612868 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04612868's enrollment target sits among peer trials
531 188th of 2000 higher than 1,813 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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