Actively Recruiting
Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS)
Led by Hospital Clinic of Barcelona · Updated on 2024-10-09
500
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 to 80 years old from our reference population
- Family history of glaucoma
- Willingness to participate
- Signed written informed consent
You will not qualify if you...
- Not signing the informed consent
- Previous diagnosis of glaucoma or any eye disease requiring regular ophthalmic exams or treatment
- Congenital or childhood glaucoma
- History of strabismus or amblyopia
- Known eye diseases causing media opacity (cataract, cornea opacities) that prevent taking fundus retinographies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínic - ICOF
Barcelona, Barcelona, Spain, 08028
Actively Recruiting
Research Team
N
Nestor Ventura Abreu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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