CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 531 enrolled
Drug / intervention
AEYE Software Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04612868
NCT04612868N/ACompleted
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Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images

AEYE Health Inc·interventional·Posted Nov 3, 2020·Updated Aug 1, 2023

In Brief

A clinical study evaluating AEYE Software Device for Diabetes Mellitus and Diabetic Retinopathy. Completed, enrolled 531 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Diabetic Retinopathy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 3, 2020
Enrollment StartOct 16, 2020
Primary CompletionNov 28, 2021
Study CompletionDec 26, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

AEYE Software Devicedevice

Eligible participants will undergo the following procedures: * Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis. * Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis. * All study subjects will have their pupils dilated using dilation drops.