Skip to main content
OpenTrials
Completed

NCT Number: NCT05703724

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZA, Edegem, Antwerpen, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI algorithm for the detection of glaucoma

Device

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

Primary outcomes

  1. Prevalence of glaucoma in Belgium

    Time frame: 4 months

    To study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary outcomes

  1. Validation of AI algorithm

    Time frame: 7 months

    To validate an existing AI-based algorithm for automatic detection of glaucoma

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Santen Oy

Registry information

Acronym: BelGlaucoma

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.