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

NCT05368623 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2023-10-16

No results posted yet for this study

Summary

Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients 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. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.

Conditions

Interventions

DIAGNOSTIC_TEST

Color fundus photograph

Subjects will undergo color fundus photography before and after pharmacological dilation of pupils.

DIAGNOSTIC_TEST

Optical Coherence Tomography (OCT) of the retina

Subjects will undergo OCT of the retina after pharmacological dilation of pupils.

DRUG

Mydriatic Agent

Pharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects

Sponsors & Collaborators

  • RETINA-AI Health, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2023-03-31
Completion
2023-03-31
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 NCT05368623 on ClinicalTrials.gov