TerminatedNANCT04699864

The Use of Artificial Intelligence in the Early Detection and the Follow-Up of Diabetic Retinopathy of Diabetic Patients Followed at the CHUM: Evaluation of NeoRetina Automated Algorithm (DIAGNOS Inc.)

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Trial Details

Condition	Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Maculopathy
Intervention	Screening of DR and DME with artificial intelligence using NeoRetina; Routine ophthalmological evaluation of DR and DME; Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos
Phase	NA
Status	Terminated
Participants	24
Est. Completion	1 July 2026
Last Updated	8 July 2026

Primary Outcome

Artificial Intelligence - Absence or Presence of Diabetic Retinopathy (DR); Eye Examination - Absence or Presence of Diabetic Retinopathy (DR); Manual Analysis of Retinal Images - Absence or Presence of Diabetic Retinopathy (DR); Artificial Intelligence - Severity of Diabetic Retinopathy (DR); Eye Examination - Severity of Diabetic Retinopathy (DR); Manual Analysis of Retinal Images - Severity of Diabetic Retinopathy (DR); Artificial Intelligence - Absence or Presence of Diabetic Macular Edema (DME); Eye Examination - Absence or Presence of Diabetic Macular Edema (DME); Manual Analysis of Retinal Images - Absence or Presence of Diabetic Macular Edema (DME); Artificial Intelligence - Severity of Diabetic Macular Edema (DME); Eye Examination - Severity of Diabetic Macular Edema (DME); Manual Analysis of Retinal Images - Severity of Diabetic Macular Edema (DME)

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Patients of 18 years old and older; 2. Ability to provide informed consent; 3. Diagnostic for diabetes : 3a) Type 1 diabetes of a lest 5 years of evolution; or 3b) Type 2 diabetes; 4. 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: 1. Patients less than 18 years old; 2. Inability to provide informed consent; 3. Patient who already had a treatment (surgery, laser, injection, etc.) for any retinal condition : Age-related macular degeneration (AMD), retinal vascular occlusion (RVO); etc.

Trial Sites

Countries

Canada

View Registry Entry

Related Analysis

Terminated Trial Analysis: NeoRetina AI Algorithm vs. Expert Ophthalmologist Grading for Diabetic Retinopathy Detection — Lessons for Clinicians

A Canadian prospective study at the Centre hospitalier de l'Université de Montréal evaluated the NeoRetina AI algorithm against specialist ophthalmologist grading for diabetic retinopathy and macular edema detection. The trial, which enrolled 24 participants before being terminated, reflects both the promise and the real-world challenges of validating AI-based retinal screening tools in clinical settings. Clinicians managing diabetic patients should monitor this evolving evidence base as scalable screening solutions remain an urgent unmet need.

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