NCT04612868

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 531 (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 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.

Conditions

• Diabetes Mellitus
• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	AEYE Software Device	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.

Timeline

• Start date: 2020-10-16
• Primary completion: 2021-11-28
• Completion: 2021-12-26
• First posted: 2020-11-03
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study