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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• Patients aged 40 to 80 years old from our reference population

• Family history of glaucoma

• Willingness to participate

• Signed written informed consent

Locations
Other Locations
Spain
Hospital Clínic - ICOF
RECRUITING
Barcelona
Contact Information
Primary
Nestor Ventura Abreu, MD, PhD
neventura@clinic.cat
+34932275400
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 500
Treatments
Experimental: AI software examination (A)
In arm A, the visual acuity, refraction status and the ancillary tests will be performed. The obtained optic disc retinography will be analyzed by the AI software to determine whether the patient was a glaucomatous, suspect or healthy patient.
Active_comparator: Ophthalmic examination (B)
In arm B, the visual acuity, refraction status and the ancillary tests will be performed, and then the patients (and the test) will be examined by a glaucoma specialist who will determine the status of the patient (glaucomatous, suspect or healthy).
Related Therapeutic Areas
Sponsors
Leads: Hospital Clinic of Barcelona

This content was sourced from clinicaltrials.gov