NCT04699864 Evaluation of NeoRetina Artificial Intelligence Algorithm for the Screening of Diabetic Retinopathy at the CHUM
| NCT ID | NCT04699864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Diabetic Retinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 630 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 630 participants in total. It began in 2024-06-10 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Karim Hammamji, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT04699864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04699864 currently recruiting?
Yes, NCT04699864 is actively recruiting participants. Contact the research team at marie-catherine.tessier.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT04699864 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04699864 clinical trial?
NCT04699864 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Karim Hammamji, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 630 participants.