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First received: January 21, 2024

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Diabetic Retinopathy, DR

Study Type: INTERVENTIONAL


Official Title: 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 Fun

Brief 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…

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