NCT05368623View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

1,100

Participants

Timeline

Start Date

November 3, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2023

Conditions
DiabetesDiabetic RetinopathyDiabetic Macular EdemaDiabetic Eye Problems
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

Trial Locations (3)

60402

Clinical Research Organization, Chicago

77074

Clinical Research Organization, Houston

92844

Clinical Research Organization, Los Angeles

All Listed Sponsors
lead

RETINA-AI Health, Inc.

INDUSTRY