Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS)
Recruiting · NCT06353542 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Clinic of Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Hospital Clínic - ICOF - Barcelona, Barcelona, Spain