Recruiting

Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS)

ClinicalTrials.gov IDNCT06353542

PhaseNA

Enrollment500

SponsorHospital Clinic of Barcelona

Age40 Years

SexALL

I'm interested View official listing

Conditions studied

Glaucoma

About this study

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.

Interventions

Diagnostic Test: Software analysis — The tested AI software analyzes the optic disc retinography to determine if the patient is healthy, a glaucoma suspect, or a glaucoma case
Diagnostic Test: Ophthalmologist examination — The ophthalmologist (a glaucoma specialist) will analyze the tests and will examine the patient to determine if the patient is healthy, a glaucoma suspect or a glaucoma case

Primary outcomes

Diagnostic agreement between the AI software and the ophthalmic examination (18 months)
Health-Related Quality of Life (HRQoL) (18 months)
Demographics (18 months)

Eligibility information

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

Study locations

Hospital Clínic - ICOF, Barcelona, Barcelona 08028 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.