NCT05857943

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

Prospective Clinical Trial to Demonstrate the Efficacy and Safety if AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images Obtained With a Funduscopic Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: AEYE Health Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	AEYE-DS Software	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 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.

Timeline

• Start date: 2023-03-29
• Primary completion: 2023-09-11
• Completion: 2023-10-10
• First posted: 2023-05-15
• Last updated: 2023-11-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study