GlaucomaBelGlaucomaNCT05703724
Prevalence of Glaucoma in Belgium: a Multicenter National Trial
A study testing AI algorithm for the detection of glaucoma in people with Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- AI algorithm for the detection of glaucoma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,418 participants
- Where
- 8 sitesBelgium
- Study dates
- 8 Mar 2023to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40 years or above
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
ZNA Middelheim
Antwerp, 2020
AZ Sint-Jan
Bruges, West-Vlaanderen, 8000
Saint-Luc (UCL)
Brussels, Brussels Capital, 1020
Hôpital Erasme
Brussels, Brussels Capital, 1070
UZA
Edegem, Antwerpen, 2650
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, 9000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
CHU Liège
Liège, Luik, 4000
About this study
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.
Read the 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
- Being tested
- AI algorithm for the detection of glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AI algorithm for the detection of glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of glaucoma in Belgium
To study the prevalence of glaucoma in the Belgian population over 40 years old
Measured: 4 months
Secondary outcomes (1)
Validation of AI algorithm
To validate an existing AI-based algorithm for automatic detection of glaucoma
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start8 Mar 2023
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Oy
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD, PhD, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703724
- Sponsor's protocol ID
- S66402
- Acronym
- BelGlaucoma
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Glaucoma in Belgium: a Multicenter National Trial
- ClinicalTrials.gov ID
- NCT05703724
- Acronym / sponsor ID
- BelGlaucoma / S66402
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,418 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Santen Oy
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Other | Device: AI algorithm for the detection of glaucomaA 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 may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 40 years or above
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI algorithm for the detection of glaucomaThe 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 | Device | Subjects |
Primary outcome
Prevalence of glaucoma in Belgium
Time frame: 4 months
To study the prevalence of glaucoma in the Belgian population over 40 years old
1 secondary outcome
Validation of AI algorithm
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, MD, PhD study chair
Universitaire Ziekenhuizen KU Leuven
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI algorithm for the detection of glaucoma in people with Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of glaucoma in Belgium (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.