NCT06353542

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

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
Hospital Clinic of Barcelona·ClinicalTrials.gov·diagnostic testNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Glaucoma
Drug/Device/Intervention
Software analysis
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Hospital Clinic of Barcelona
Location
Barcelona, Spain
Timeline & enrollment
Phase
N/A
Start date
May 02, 2024
End date
Sep 01, 2026
Enrollment
500 participants
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
GlaucomaGlaucomaOther glaucomaGlaucoma, unspecifiedGlaucoma in diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353542
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06353542 through Pure Global AI's free database. This phase not specified trial is sponsored by Hospital Clinic of Barcelona and is currently Not yet recruiting. The study focuses on Glaucoma. Target enrollment is 500 participants.

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