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

NCT06353542 | Recruiting

• 2 other identifiers: HCB/2023/1206PI23/01856
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

Artificial Intelligence; Diagnostic Test: Glaucoma Screening

Outcome Measures

Primary Outcomes (3)

• Diagnostic agreement between the AI software and the ophthalmic examination

  Level of agreement between the casted result by the AI software and the ophthalmic examination. This will be determined by the reading person (study chair)

  18 months

• Health-Related Quality of Life (HRQoL)

  Health-Related Quality of Life (HRQoL) assessed by Euro Quality of Life -5 Dimensions (EQ-5D), for each arm of the clinical trial. It consists of a visual analog scale, ranging from 0 to 100 (0 being the worst imaginable health and 100 the best health the patient can imagine)

  18 months

• Demographics

  Quantitative analysis of age, gender, ethnicity, and family history of glaucoma differences between the two arms

  18 months

Secondary Outcomes (5)

• Intraocular pressure

  18 months

• Optical coherence tomography (OCT)

  18 months

• Visual field

  18 months

• Cost-effective analysis of both screening methods

  18 months

• Risk score with parameters associated with positive screening of glaucoma

  6 months

Study Arms (2)

AI software examination (A)

EXPERIMENTAL

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.

Diagnostic Test: Software analysis

Ophthalmic examination (B)

ACTIVE COMPARATOR

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).

Diagnostic Test: Ophthalmologist examination

Interventions

Software analysis DIAGNOSTIC_TEST

The tested AI software analyzes the optic disc retinography to determine if the patient is healthy, a glaucoma suspect, or a glaucoma case

AI software examination (A)

Ophthalmologist examination DIAGNOSTIC_TEST

The ophthalmologist (a glaucoma specialist) will analyze the tests and will examine the patient to determine if the patient is healthy, a glaucoma suspect or a glaucoma case

Ophthalmic examination (B)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40 to 80 years old from our reference population
• Family history of glaucoma
• Willingness to participate
• Signed written informed consent

You may not qualify if:

• Not signing the informed consent
• Patients that had a previous diagnosis of glaucoma or any ophthalmic disease that required a regular ophthalmic examination and/or treatment
• Congenital or childhood glaucoma
• History of strabismus or amblyopia
• Known ophthalmic diseases which imply media opacity (cataract, cornea opacities) that might preclude from taking fundus retinographies

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic - ICOF

Barcelona, Barcelona, 08028, Spain

RECRUITING

Related Publications (3)

• Hemelings R, Elen B, Barbosa-Breda J, Lemmens S, Meire M, Pourjavan S, Vandewalle E, Van de Veire S, Blaschko MB, De Boever P, Stalmans I. Accurate prediction of glaucoma from colour fundus images with a convolutional neural network that relies on active and transfer learning. Acta Ophthalmol. 2020 Feb;98(1):e94-e100. doi: 10.1111/aos.14193. Epub 2019 Jul 25.

  PMID: 31344328 BACKGROUND

• US Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Krist AH, Kubik M, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 May 18;325(19):1965-1977. doi: 10.1001/jama.2021.6238.

  PMID: 34003218 BACKGROUND

• Tan NYQ, Friedman DS, Stalmans I, Ahmed IIK, Sng CCA. Glaucoma screening: where are we and where do we need to go? Curr Opin Ophthalmol. 2020 Mar;31(2):91-100. doi: 10.1097/ICU.0000000000000649.

  PMID: 31904596 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Marta Pazos, MD, PhD

  Glaucoma Consultant - Head of Ophthalmic Surgery Department

  STUDY CHAIR

Central Study Contacts

Nestor Ventura Abreu, MD, PhD

CONTACT

+34932275400; neventura@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 9, 2024
• Study Start: May 2, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)