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| Name | Class |
|---|---|
| Santen Oy | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI algorithm for the detection of glaucoma | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of glaucoma in Belgium | To study the prevalence of glaucoma in the Belgian population over 40 years old | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of AI algorithm | To validate an existing AI-based algorithm for automatic detection of glaucoma | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingeborg Stalmans, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Edegem | Antwerpen | 2650 | Belgium | ||
| Saint-Luc (UCL) |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Brussels |
| Brussels Capital |
| 1020 |
| Belgium |
| Hôpital Erasme | Brussels | Brussels Capital | 1070 | Belgium |
| CHU Liège | Liège | Luik | 4000 | Belgium |
| AZ Sint-Lucas | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ Sint-Jan | Bruges | West-Vlaanderen | 8000 | Belgium |
| ZNA Middelheim | Antwerp | 2020 | Belgium |