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Artificial Intelligence

AI Screening for Diabetic Retinopathy (DR-NeoRetina Trial)

N/A
Recruiting
Led By Salim Lahoud, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test if an artificial intelligence algorithm called NeoRetina, created by DIAGNOS Inc., can accurately detect and grade the severity of diabetic retinopathy by analyzing eye fundus photographs."

Who is the study for?
This trial is for adults over 18 with diabetes (Type 1 for at least 5 years, or Type 2) who are being treated or referred by the CHUM hospital. They must be able to give informed consent. It's not suitable for those who don't meet these specific conditions.
What is being tested?
The study tests NeoRetina, an AI algorithm designed to detect and grade diabetic retinopathy severity from eye photos. It compares routine eye exams and manual grading by ophthalmologists against this new AI screening method.
What are the potential side effects?
Since this trial involves non-invasive screening methods rather than medication, there are no direct side effects associated with the interventions being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Artificial Intelligence - Absence or Presence of Diabetic Macular Edema (DME)
Artificial Intelligence - Absence or Presence of Diabetic Retinopathy (DR)
Artificial Intelligence - Severity of Diabetic Macular Edema (DME)
+9 more
Secondary study objectives
Performance of NeoRetina Algorithm - Diabetic Macular Edema (DME)
Performance of NeoRetina Algorithm - Diabetic Retinopathy (DR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diabetic Retinopathy (DR)Experimental Treatment3 Interventions
Screening of DR with artificial intelligence (NeoRetina algorithm) and diagnostic evaluation with a standard of care ophthalmological examination.

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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
380 Previous Clinical Trials
130,959 Total Patients Enrolled
DIAGNOS Inc.UNKNOWN
Salim Lahoud, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Karim Hammamji, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
~210 spots leftby Apr 2025
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