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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AI algorithm for the detection of glaucoma
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Glaucoma

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZA
  • Saint-Luc (UCL)
  • Hôpital Erasme
  • CHU Liège
  • AZ Sint-Lucas
  • UZ Leuven
  • AZ Sint-Jan
  • ZNA Middelheim

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

Prevalence of glaucoma in Belgium
To study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary Outcome Measures

Validation of AI algorithm
To validate an existing AI-based algorithm for automatic detection of glaucoma

Full Information

First Posted
January 19, 2023
Last Updated
May 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Santen Oy
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1. Study Identification

Unique Protocol Identification Number
NCT05703724
Brief Title
Prevalence of Glaucoma in Belgium: a Multicenter National Trial
Acronym
BelGlaucoma
Official Title
Prevalence of Glaucoma in Belgium: a Multicenter National Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Santen Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AI algorithm for the detection of glaucoma
Intervention Description
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
Primary Outcome Measure Information:
Title
Prevalence of glaucoma in Belgium
Description
To study the prevalence of glaucoma in the Belgian population over 40 years old
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Validation of AI algorithm
Description
To validate an existing AI-based algorithm for automatic detection of glaucoma
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Stalmans, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Chair
Facility Information:
Facility Name
UZA
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Saint-Luc (UCL)
City
Brussel
State/Province
Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussel
State/Province
Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Liège
City
Liège
State/Province
Luik
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Sint-Lucas
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

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