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Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

NCT04774822 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 397

Last updated 2021-09-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Color Fundus Photography

Stereoscopic Fundus photography

DRUG

Mydriatics Agent

Eye dilating agent

PROCEDURE

Optical Coherence Tomography (OCT)

Optical Tomographic imaging of retina

Sponsors & Collaborators

  • RETINA-AI Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2021-05-28
Completion
2021-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774822 on ClinicalTrials.gov