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

> **NCT04612868** · NA · COMPLETED · sponsor: **AEYE Health Inc** · enrollment: 531 (actual)

## Conditions studied

- Diabetes Mellitus
- Diabetic Retinopathy

## Interventions

- **DEVICE:** AEYE Software Device

## Key facts

- **NCT ID:** NCT04612868
- **Lead sponsor:** AEYE Health Inc
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-10-16
- **Primary completion:** 2021-11-28
- **Final completion:** 2021-12-26
- **Target enrollment:** 531 (ACTUAL)
- **Last updated:** 2023-08-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04612868

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04612868, "Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images". Retrieved via AI Analytics 2026-07-01 from https://api.ai-analytics.org/clinical/NCT04612868. Licensed CC0.

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