Prevalence of Glaucoma in Belgium: a Multicenter National Trial (BelGlaucoma)

May 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
To screen for the presence of glaucoma in a Belgian population over 40 years old using an AI algorithm developed for the detection of glaucoma based on fundus pictures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we aim to detect individuals with glaucoma and refer them for further evaluation and treatment when necessary. In so doing, we want to get an estimation of the prevalence of glaucoma in the Belgian population of 40+ years.

A fundus picture will be acquired without pupil dilation. This examination will be followed by an intra-ocular pressure measurement. The results will be discussed with the participating subject by the present physician. For each subject, both eyes will be evaluated. In case of suspected glaucoma, the subject will be referred to an ophthalmologist for further evaluation.

Study Type

Interventional

Enrollment (Actual)

1418

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Zna Middelheim
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZA
    • Brussels Hoofdstedelijk Gewest
      • Brussel, Brussels Hoofdstedelijk Gewest, Belgium, 1020
        • Saint-Luc (UCL)
      • Brussel, Brussels Hoofdstedelijk Gewest, Belgium, 1070
        • Hôpital Erasme
    • Luik
      • Liège, Luik, Belgium, 4000
        • CHU Liège
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • AZ Sint-Lucas
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • AZ Sint-Jan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 40 years or above

Exclusion Criteria:

  • Aged under 40 years
  • Insufficient knowledge of Dutch, French or English required to complete the imaging protocol and questionnaire
  • Physical or mental inability to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects
A fundus picture will be acquired without pupil dilation. This examination will be followed by an intra-ocular pressure measurement. The results will be discussed with the participating subject by the present physician. For each subject, both eyes will be evaluated. In case of suspected glaucoma, the subject will be referred to an ophthalmologist for further evaluation.
Device: AI algorithm for the detection of glaucoma
The investigational device that will be used during this study is an AI algorithm embedded into an API for the detection of glaucoma developed by MONA.health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of glaucoma in Belgium
Time Frame: 4 months
To study the prevalence of glaucoma in the Belgian population over 40 years old
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of AI algorithm
Time Frame: 7 months
To validate an existing AI-based algorithm for automatic detection of glaucoma
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Santen Oy

Investigators

  • Study Chair: Ingeborg Stalmans, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S66402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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