# Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device

> **NCT05368623** · — · COMPLETED · sponsor: **RETINA-AI Health, Inc.** · enrollment: 1100 (actual)

## Conditions studied

- Diabetes
- Diabetic Retinopathy
- Diabetic Macular Edema
- Diabetic Eye Problems

## Interventions

- **DIAGNOSTIC_TEST:** Color fundus photograph
- **DIAGNOSTIC_TEST:** Optical Coherence Tomography (OCT) of the retina
- **DRUG:** Mydriatic Agent

## Key facts

- **NCT ID:** NCT05368623
- **Lead sponsor:** RETINA-AI Health, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2022-11-03
- **Primary completion:** 2023-03-31
- **Final completion:** 2023-03-31
- **Target enrollment:** 1100 (ACTUAL)
- **Last updated:** 2023-10-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05368623

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05368623, "Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT05368623. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*