TerminatedNot Applicable

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

Stopped: logistical constraints

Canada24 participantsStarted 2024-06-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Artificial Intelligence - Severity of Diabetic Retinopathy (DR)

Timeframe: Baseline

Eye Examination - Severity of Diabetic Retinopathy (DR)

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Trial details

NCT IDNCT04699864

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Diabetic Retinopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Artificial Intelligence - Severity of Diabetic Retinopathy (DR)

Timeframe: Baseline

Eye Examination - Severity of Diabetic Retinopathy (DR)

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline