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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Glaucoma

Treatments: Device: AI algorithm for the detection of glaucoma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05703724

S66402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,418 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,418 participants in 1 patient group

Subjects

Other group

Description:

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.

Treatment:

Device: AI algorithm for the detection of glaucoma