Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Public ClinicalTrials.gov record NCT04774822. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.
Study identification
- NCT ID
- NCT04774822
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 397 participants
Conditions and interventions
Interventions
- Color Fundus Photography Procedure
- Mydriatics Agent Drug
- Optical Coherence Tomography (OCT) Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2021
- Primary completion
- May 27, 2021
- Completion
- Aug 30, 2021
- Last update posted
- Sep 15, 2021
2021
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Biopharma Informatic, LLC | Houston | Texas | 77043 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Biopharma Informatic LLC | Houston | Texas | 77084 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04774822, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04774822 live on ClinicalTrials.gov.