Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS) - Trial NCT06353542

Timeline & Enrollment

Primary Outcome

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

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.

ICD-10 Classifications