NCT06353542 Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS)
| NCT ID | NCT06353542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2024-05-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care. Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP). The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist. In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis. This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them. Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process.
Eligibility Criteria
Inclusion Criteria: * Patients aged 40 to 80 years old from our reference population * Family history of glaucoma * Willingness to participate * Signed written informed consent Exclusion Criteria: * Not signing the informed consent * Patients that had a previous diagnosis of glaucoma or any ophthalmic disease that required a regular ophthalmic examination and/or treatment * Congenital or childhood glaucoma * History of strabismus or amblyopia * Known ophthalmic diseases which imply media opacity (cataract, cornea opacities) that might preclude from taking fundus retinographies
Contact & Investigator
Marta Pazos, MD, PhD
STUDY CHAIR
Glaucoma Consultant - Head of Ophthalmic Surgery Department
Frequently Asked Questions
Who can join the NCT06353542 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06353542 currently recruiting?
Yes, NCT06353542 is actively recruiting participants. Contact the research team at neventura@clinic.cat for enrollment information.
Where is the NCT06353542 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06353542 clinical trial?
NCT06353542 is sponsored by Hospital Clinic of Barcelona. The principal investigator is Marta Pazos, MD, PhD at Glaucoma Consultant - Head of Ophthalmic Surgery Department. The trial plans to enroll 500 participants.