Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT06353542

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

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Hospital Clínic - ICOF

Barcelona, Barcelona, Spain, 08028

Actively Recruiting

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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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