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NCT05703724 Clinical Trial

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Glaucoma Clinical Trial

— BelGlaucoma  

Official title:
Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05703724
Other study ID # S66402
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2023
Est. completion date May 8, 2023

Study information
Verified date January 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1418
Est. completion date May 8, 2023
Est. primary completion date May 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium ZNA Middelheim Antwerpen
Belgium AZ Sint-Jan Brugge West-Vlaanderen
Belgium Hôpital Erasme Brussel Brussels Hoofdstedelijk Gewest
Belgium Saint-Luc (UCL) Brussel Brussels Hoofdstedelijk Gewest
Belgium UZA Edegem Antwerpen
Belgium AZ Sint-Lucas Gent Oost-Vlaanderen
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium CHU Liège Liège Luik

Sponsors (2)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven Santen Oy

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of glaucoma in Belgium To study the prevalence of glaucoma in the Belgian population over 40 years old 4 months
Secondary Validation of AI algorithm To validate an existing AI-based algorithm for automatic detection of glaucoma 7 months
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