Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: AI algorithm for the detection of glaucoma

• Registration Number: NCT05703724
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-03-08
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1418

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	AI algorithm for the detection of glaucoma	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of glaucoma in Belgium	4 months	To study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary Outcome Measures

Name	Time	Method
Validation of AI algorithm	7 months	To validate an existing AI-based algorithm for automatic detection of glaucoma

Trial Locations

Locations (8)

Hôpital Erasme; 🇧🇪 Brussel, Brussels Hoofdstedelijk Gewest, Belgium

Saint-Luc (UCL); 🇧🇪 Brussel, Brussels Hoofdstedelijk Gewest, Belgium

UZA; 🇧🇪 Edegem, Antwerpen, Belgium

CHU Liège; 🇧🇪 Liège, Luik, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

AZ Sint-Jan; 🇧🇪 Brugge, West-Vlaanderen, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Sint-Lucas; 🇧🇪 Gent, Oost-Vlaanderen, Belgium