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Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05703724
Acronym
BelGlaucoma
Enrollment
1418
Registered
2023-01-30
Start date
2023-03-08
Completion date
2023-05-08
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DEVICEAI 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

Sponsors

Santen Oy
CollaboratorINDUSTRY
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of glaucoma in Belgium4 monthsTo study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary

MeasureTime frameDescription
Validation of AI algorithm7 monthsTo validate an existing AI-based algorithm for automatic detection of glaucoma

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026