Evaluation of NeoRetina Artificial Intelligence Algorithm for the Screening of Diabetic Retinopathy at the CHUM (DR-NeoRetina)

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Enrolling

Conditions

Diabetic Macular Edema

Diabetic Maculopathy

Diabetic Retinopathy

Treatments

Diagnostic Test: Screening of DR and DME with artificial intelligence using NeoRetina

Diagnostic Test: Routine ophthalmological evaluation of DR and DME

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04699864

20.292

Details and patient eligibility

About

This prospective study aims to validate if NeoRetina, an artificial intelligence algorithm developped by DIAGNOS Inc. and trained to automatically detect the presence of diabetic retinopathy (DR) by the analysis of macula centered eye fundus photographies, can detect this disease and grade its severity.

Full description

More than 880 000 Quebecers (more than 10% of the population) suffer from diabetes, which is the main cause of blindness in diabetic adults under 65 years of age, and around 40% of people with diabetes suffer from diabetic retinopathy (DR). The early detection of DR and a regular follow-up is thus crucial to prevent the progression of this disease.

However, the public health care system in Quebec does not actually have the capacity to allow all people with diabetes to see an ophthalmologist within a short delay. Artificial intelligence might help in screening DR and in refering to eye doctors only patients who suffer from this eye disease.

The investigators of this study hypothesize that artificial intelligence (AI) is a useful technology for the screening of diabetic retinopathy (DR) that can detect the absence or the presence of DR with an efficiency and an accuracy similar to that of an ophthalmological evaluation.

The goal of this study is to compare the screening results of DR obtained with NeoRetina pure artificial intelligence algorithm (automated analysis of color photos of the retina) with the results of a routine ophthalmological evaluation done in a clinical context at the Centre hospitalier de l'Université de Montréal (CHUM).

The main objective of this study is to determine if artificial intelligence (AI) could be a useful technology for the early detection and the follow-up of diabetic retinopathy (DR).

The first specific objective is to determine the efficiency and the accuracy of NeoRetina (DIAGNOS Inc.) automated algorithm for the screening and the grading of the severity of diabetic retinopathy (DR) by the analysis of eye fundus images from diabetic patients compared to that of an eye examination done by an ophthalmologist in a clinical context.

The second specific objective is to evaluate if NeoRetina can determine, with efficiency and accuracy, the absence of diabetic retinopathy (DR), the presence of diabetic retinopathy (DR) and the severity of the disease.

Recruited diabetic participants will be screened for DR by AI with NeoRetina. Participants will also have a full eye examination (blind assessment) with an ophthalmologist of the CHUM in order to determine if they suffer from this eye complication of diabetes.

The results of the screening done by AI with NeoRetina will be compared to those of the ocular evaluation done by an ophthalmologist. Ophthalmologists from the CHUM will also revise the retinal images acquired by DIAGNOS (blind assessment) in order to determine if DR is present and will manually grade the severity of the disease.

Enrollment

630 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of 18 years old and older;
Ability to provide informed consent;
Diagnostic for diabetes : 3a) Type 1 diabetes of a lest 5 years of evolution; or 3b) Type 2 diabetes;
Diabetic patient followed and refered by a physician of the Centre hospitalier de l'Université de Montréal (CHUM) : 4a) followed by an endocrinologist of the CHUM; or 4b) hospitalized at the CHUM; or 4c) on the waiting list of the Ophthalmology Clinic of the CHUM for the evaluation of DR.

Exclusion criteria

Patients less than 18 years old;
Inability to provide informed consent;
Patient who already had a treatment (surgery, laser, injection, etc.) for any retinal condition : Age-related macular degeneration (AMD), retinal vascular occlusion (RVO); etc.