NCT06241664

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

Prospective Clinical Trial to Demonstrate the Efficacy and Safety of the AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images Obtained With Multiple Fundoscopy Camera Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: AEYE Health Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Retinopathy, DR
• Diabetic Mellitus

Interventions

Type	Name	Description
DEVICE	AEYE-DS Software	An Artificial Intelligence (AI) software device to be used as a diagnostic tool to assist healthcare providers in screening for diabetic retinopathy (DR) using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with DR.

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-10-02
• Completion: 2025-02-20
• First posted: 2024-02-05
• Last updated: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study