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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma

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