NCT06241664

Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images

Completed NA Last updated 18 March 2025

What this trial tests

NA trial testing AEYE-DS Software in Diabetic Retinopathy, DR in 601 participants. Completed in 20 February 2025.

Timeline

31 January 2024

Primary endpoint
2 October 2024

20 February 2025

Quick facts

Lead sponsor	AEYE Health Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	601
Start date	31 January 2024
Primary completion	2 October 2024
Estimated completion	20 February 2025
Sites	1 location across United States

Drugs / interventions tested

• AEYE-DS Software

Conditions studied

• Diabetic Retinopathy, DR — all drugs for Diabetic Retinopathy, DR →
• Diabetic Mellitus — all drugs for Diabetic Mellitus →

Sponsor

AEYE Health Inc

Who can join

22 and older, any sex, with Diabetic Retinopathy, DR or Diabetic Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy (mtmDR) in adult participants diagnosed with Diabetic Mellitus (DM) using fundoscopic images of the eyes. The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy (mtmDR) in patients with known diabetes using digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye.

Participants:

* will have an eye exam in which photographic images of each eye will be taken by a novice operator, using four different FDA approved/registered fundoscopy cameras. These images will be sent to and analyzed by the AEYE-DS software device.
* will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer. These images will be sent to an independent reading center for analysis.
* will have dilation drops put in their eyes (either during or after the imaging with the fundoscopy cameras), wait about 30 minutes for the pupils to dilate and continue the eye imaging exams.

The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.