NCT05703724

Prevalence of Glaucoma in Belgium: a Multicenter National Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,418 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2023-01-30
• Last updated: 2023-05-31

Locations

8 sites across 1 country: Belgium