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

NCT04699864 | Recruiting

• 1 other identifier: 20.292
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema; Diabetic Maculopathy

Keywords

Diabetes; Type 1 Diabetes; Type 2 Diabetes; Diabetic Retinopathy (DR); Diabetic Macular Edema (DME); Ophthalmological Evaluation; Screening of Diabetic Retinopathy; Eye Disease; Eye Complications of Diabetes; Diabetes Mellitus; Artificial Intelligence

Outcome Measures

Primary Outcomes (12)

• Artificial Intelligence - Absence or Presence of Diabetic Retinopathy (DR)

  Analysis of retinal images by artificial intelligence (NeoRetina) to determine the absence or the presence of diabetic retinopathy (DR) * R0 : No DR * R+ : Presence of DR

  Baseline

• Eye Examination - Absence or Presence of Diabetic Retinopathy (DR)

  Eye examination done by an ophthalmologist to determine the absence or the presence of diabetic retinopathy (DR) (blind assessment) * R0 : No DR * R+ : Presence of DR

  Baseline

• Manual Analysis of Retinal Images - Absence or Presence of Diabetic Retinopathy (DR)

  Manual analysis of retinal images acquired by Diagnos by an ophthalmologist of the CHUM to determine the absence or the presence of diabetic retinopathy (DR) (blind assessment) * R0 : No DR * R+ : Presence of DR

  Baseline

• Artificial Intelligence - Severity of Diabetic Retinopathy (DR)

  Analysis of retinal images by artificial intelligence (NeoRetina) to grade the severity of diabetic retinopathy (DR) * R1 - Mild NPDR: Mild Nonproliferative Diabetic Retinopathy * R2 - Moderate NPDR: Moderate Nonproliferative Diabetic Retinopathy * R3 - Severe NPDR : Severe Nonproliferative Diabetic Retinopathy * R4 - PDR : Proliferative Diabetic Retinopathy

  Baseline

• Eye Examination - Severity of Diabetic Retinopathy (DR)

  Eye examination done by an ophthalmologist to grade the severity of diabetic retinopathy (DR) (blind assessment) * R1 - Mild NPDR: Mild Nonproliferative Diabetic Retinopathy * R2 - Moderate NPDR: Moderate Nonproliferative Diabetic Retinopathy * R3 - Severe NPDR : Severe Nonproliferative Diabetic Retinopathy * R4 - PDR : Proliferative Diabetic Retinopathy

  Baseline

• Manual Analysis of Retinal Images - Severity of Diabetic Retinopathy (DR)

  Manual revision of retinal images acquired by Diagnos by an ophthalmologist of the CHUM to grade the severity of diabetic retinopathy (DR) (blind assessment) * R1 - Mild NPDR: Mild Nonproliferative Diabetic Retinopathy * R2 - Moderate NPDR: Moderate Nonproliferative Diabetic Retinopathy * R3 - Severe NPDR : Severe Nonproliferative Diabetic Retinopathy * R4 - PDR : Proliferative Diabetic Retinopathy

  Baseline

• Artificial Intelligence - Absence or Presence of Diabetic Macular Edema (DME)

  Analysis of retinal images by artificial intelligence (NeoRetina) to determine the absence or the presence of diabetic macular edema (DME) * M0 : No DME * M+ : Presence of DME

  Baseline

• Eye Examination - Absence or Presence of Diabetic Macular Edema (DME)

  Eye examination done by an ophthalmologist to determine the absence or the presence of diabetic macular edema (DME) (blind assessment) * M0 : No DME * M+ : Presence of DME

  Baseline

• Manual Analysis of Retinal Images - Absence or Presence of Diabetic Macular Edema (DME)

  Manual analysis of retinal images acquired by Diagnos by an ophthalmologist of the CHUM to determine the absence or the presence of diabetic macular edema (DME) (blind assessment) * M0 : No DME * M+ : Presence of DME

  Baseline

• Artificial Intelligence - Severity of Diabetic Macular Edema (DME)

  Analysis of retinal images by artificial intelligence (NeoRetina) to grade the severity of diabetic macular edema (DME) * M1 : Non Central DME * M2 : Central DME

  Baseline

• Eye Examination - Severity of Diabetic Macular Edema (DME)

  Eye examination done by an ophthalmologist to grade the severity of diabetic macular edema (DME) (blind assessment) * M1 : Non Central DME * M2 : Central DME

  Baseline

• Manual Analysis of Retinal Images - Severity of Diabetic Macular Edema (DME)

  Manual analysis of retinal images acquired by Diagnos by an ophthalmologist of the CHUM to grade the severity of diabetic macular edema (DME) (blind assessment) * M1 : Non Central DME * M2 : Central DME

  Baseline

Secondary Outcomes (2)

• Performance of NeoRetina Algorithm - Diabetic Retinopathy (DR)

  3 years

• Performance of NeoRetina Algorithm - Diabetic Macular Edema (DME)

  3 years

Study Arms (1)

Diabetic Retinopathy (DR)

EXPERIMENTAL

Screening of DR with artificial intelligence (NeoRetina algorithm) and diagnostic evaluation with a standard of care ophthalmological examination.

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

Interventions

Screening of DR and DME with artificial intelligence using NeoRetina DIAGNOSTIC_TEST

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.

Diabetic Retinopathy (DR)

Routine ophthalmological evaluation of DR and DME DIAGNOSTIC_TEST

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.

Diabetic Retinopathy (DR)

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

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.

Diabetic Retinopathy (DR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• DIAGNOS Inc.: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Related Publications (2)

• Unité d'évaluation des technologies et des modes d'intervention en santé (UETMIS). Centre hospitalier de l'Université de Montréal. Projet pilote : application de l'intelligence artificielle en ophtalmologie. Revue de la littérature et étude de terrain, phase I. Préparée par Imane Hammana et Alfons Pomp. Février 2020.

  BACKGROUND

• Shaban M, Ogur Z, Mahmoud A, Switala A, Shalaby A, Abu Khalifeh H, Ghazal M, Fraiwan L, Giridharan G, Sandhu H, El-Baz AS. A convolutional neural network for the screening and staging of diabetic retinopathy. PLoS One. 2020 Jun 22;15(6):e0233514. doi: 10.1371/journal.pone.0233514. eCollection 2020.

  PMID: 32569310 BACKGROUND

Related Links

• Diabetes Quebec - Understanding Diabetes : Myths and Statistics
• DIAGNOS Inc.

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Eye Diseases

Condition Hierarchy (Ancestors)

Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Karim Hammamji, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Catherine Tessier, MSc

CONTACT

514-890-8000; marie-catherine.tessier.chum@ssss.gouv.qc.ca

Karim Hammamji, MD

CONTACT

514-890-8000; ophtalmologie.recherche.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 7, 2021
• Study Start: June 10, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)