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

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05703724

Collaborator

Santen Oy (Industry)

600

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: AI algorithm for the detection of glaucoma	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Subjects

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

Outcome Measures

Primary Outcome Measures

Prevalence of glaucoma in Belgium [4 months]
To study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary Outcome Measures

Validation of AI algorithm [7 months]
To validate an existing AI-based algorithm for automatic detection of glaucoma

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZA	Edegem	Antwerpen	Belgium	2650
2	Saint-Luc (UCL)	Brussel	Brussels Hoofdstedelijk Gewest	Belgium	1020
3	Hôpital Erasme	Brussel	Brussels Hoofdstedelijk Gewest	Belgium	1070
4	CHU Liège	Liège	Luik	Belgium	4000
5	AZ Sint-Lucas	Gent	Oost-Vlaanderen	Belgium	9000
6	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000
7	AZ Sint-Jan	Brugge	West-Vlaanderen	Belgium	8000
8	ZNA Middelheim	Antwerpen		Belgium	2020

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven
Santen Oy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen KU Leuven

ClinicalTrials.gov Identifier:

NCT05703724

Other Study ID Numbers:

S66402

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Jan 30, 2023