Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Screening
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2023

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

• 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

Arms, Groups and Cohorts

• 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.

Clinical Trial Outcome Measures

Primary Measures

• Prevalence of glaucoma in Belgium
  • Time Frame: 4 months
  • To study the prevalence of glaucoma in the Belgian population over 40 years old

Secondary Measures

• Validation of AI algorithm
  • Time Frame: 7 months
  • To validate an existing AI-based algorithm for automatic detection of glaucoma

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Universitaire Ziekenhuizen KU Leuven
• Collaborator
  • Santen Oy
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Ingeborg Stalmans, MD, PhD, Study Chair, Universitaire Ziekenhuizen KU Leuven
• Overall Contact(s)
  • Sarah Spileers, SC, +32 16 34 03 91, oogziekten.glaucoomstudies@uzleuven.be