Evaluation of NeoRetina Artificial Intelligence Algorithm for the Screening of Diabetic Retinopathy at the CHUM

NARecruitingINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

June 10, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

December 31, 2026

Conditions
Diabetic RetinopathyDiabetic Macular EdemaDiabetic Maculopathy
Interventions
DIAGNOSTIC_TEST

Screening of DR and DME with artificial intelligence using NeoRetina

Macula-centered eye color fundus photos will be acquired by DIAGNOS team using a non-mydriatic digital camera (without pupil dilation). After a numerical treatment, retinal images will be analyzed by NeoRetina artificial intelligence (AI) algorithm in order to find eye lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by NeoRetina according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.

DIAGNOSTIC_TEST

Routine ophthalmological evaluation of DR and DME

Standard of care eye examination (blind assessment) will be performed by an ophthalmologist of the CHUM in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by the doctor according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.

DIAGNOSTIC_TEST

Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos

Ophthalmologists of the CHUM will revise the macula-centered eye color photos acquired by DIAGNOS in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded (blind assessment) according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.

Trial Locations (1)

H2X 0A9

RECRUITING

Centre hospitalier de l'Université de Montréal, Montreal

All Listed Sponsors
collaborator

DIAGNOS Inc.

UNKNOWN

lead

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER