Prevalence of Glaucoma in Belgium: a Multicenter National Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-05-08

Brief Summary

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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.

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Detailed Description

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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

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

AI algorithm for the detection of glaucoma

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes