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

  • STATUS
    Recruiting
  • sponsor
    AEYE Health LLC
Updated on 12 May 2021

Summary

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

Description

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 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.

Details
Condition Diabetic Retinopathy, Diabetic Macular Edema, Diabetes Mellitus Types I and II
Clinical Study IdentifierTX268369
SponsorAEYE Health LLC
Last Modified on12 May 2021

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