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RECRUITING
NCT06353542
NA

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

Sponsor: Hospital Clinic of Barcelona

View on ClinicalTrials.gov

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.

Official title: Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS): Artificial Intelligence Applied to Optic Nerve Retinographies for a Glaucoma Screening Program in a Primary-care Setting

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-05-02

Completion Date

2026-09

Last Updated

2024-10-09

Healthy Volunteers

Yes

Conditions

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

Locations (1)

Hospital Clínic - ICOF

Barcelona, Barcelona, Spain