protocolSection identificationModule nctId: NCT06353542, orgStudyIdInfo id: HCB/2023/1206, secondaryIdInfos id: PI23/01856, type: OTHER, domain: Institut d'Investigacions Biomèdiques August Pi i Sunyer, briefTitle: Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS), acronym: BEGAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Software analysis, interventions name: Ophthalmologist examination, outcomesModule primaryOutcomes measure: Diagnostic agreement between the AI software and the ophthalmic examination, primaryOutcomes measure: Health-Related Quality of Life (HRQoL), primaryOutcomes measure: Demographics, secondaryOutcomes measure: Intraocular pressure, secondaryOutcomes measure: Optical coherence tomography (OCT), secondaryOutcomes measure: Visual field, secondaryOutcomes measure: Cost-effective analysis of both screening methods, secondaryOutcomes measure: Risk score with parameters associated with positive screening of glaucoma, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic - ICOF, city: Barcelona, zip: 08028, country: Spain, contacts name: Nestor Ventura Abreu, MD, PhD, role: CONTACT, phone: +34932275400, phoneExt: 9336, email: neventura@clinic.cat, contacts name: Marta Pazos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False