NCT05703724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

May 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 19, 2023

Last Update Submit

May 26, 2023

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Prevalence of glaucoma in Belgium

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

    4 months

Secondary Outcomes (1)

  • Validation of AI algorithm

    7 months

Study Arms (1)

Subjects

OTHER

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.

Device: AI algorithm for the detection of glaucoma

Interventions

AI algorithm for the detection of glaucomaDEVICE

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

Subjects

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40 years or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UZA

Edegem, Antwerpen, 2650, Belgium

Location

Saint-Luc (UCL)

Brussels, Brussels Capital, 1020, Belgium

Location

Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

CHU Liège

Liège, Luik, 4000, Belgium

Location

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Ingeborg Stalmans, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

March 8, 2023

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

May 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(8)