Glaucoma Portugal Screening Trial

NCT05875090 | Enrolling By Invitation

• 1 other identifier: 38/23
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 3

Brief Summary

Two primary care-based screening systems will be used to identify subjects with referrable glaucoma to hospital care. Subjects between 55 to 65 years old living in two primary care areas (urban area in Lisbon ; countryside setting in Minho) will be invited to a one-time assessment of optic disc and intraocular pressure (IOP). Criteria for referral will differ between centers, with one arm (Lisbon) using an artificial intelligence (AI) reading software of the optic disc picture, the other (Minho) will base their referral based on optical coherence tomography (OCT) retinal nerve fibre layer abnormality. A masked reading center will be established to set the ground truth for diagnosis. This pilot screening trial will explore the level of agreement between both systems as well as their cost effectiveness and identify diagnostic composite scores that could maximize the screening process. Secondary analyses will include the identification of population characteristics that increase effectivity of screening process as well as determining the population less likely to adhere to screening programmes.

Conditions

Glaucoma

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

• Diagnostic agreement between referring decision and reading center decision

  Level of agreement will be done between referring decision and the ground truth as assessed by the reading center (normal, glaucoma suspect; definitive glaucoma). All subjects from both centers (referred and non-referred) will be reviewed. For a primary outcome analysis, the middle category (glaucoma suspect) will be pooled together with the normal diagnosis

  Duration of the study (8 months)

Secondary Outcomes (6)

• Comparison between level of agreement (with ground truth) from both screening models

  Duration of the study (8 months)

• Level of performance of agreement by number of diagnostic testing

  Duration of the study (8 months)

• Cost effective analysis of both screening models

  Duration of the study (8 months)

• Subjects parameters associated with positive screening

  Duration of the study (8 months)

• Parameters associated with accepting screening system by the patients

  Duration of the study (8 months)

Study Arms (2)

AI-enhanced Retinography-based screening

EXPERIMENTAL

Screening in Lisbon arm will be done by an Artificial Intelligence (AI) software reading an optic disc entered retinography. Outcome of this analysis is referral vs non-referral based on a pre-established threshold. IOP 24mmHg or higher will be also be referred, regardless of optics disc analysis

Diagnostic Test: Glaucoma Screening

OCT-based screening

ACTIVE COMPARATOR

Screening in the Minho arm will be done based on optic coherence Tomography (OCT) retinal nerve fibre layer thickness (RNFL). Existence of a single sector outside normal limits (\>95%) will be considered referrable. IOP 24mmHg or higher will be also be referred, regardless of optics disc analysis

Diagnostic Test: Glaucoma Screening

Interventions

Glaucoma Screening DIAGNOSTIC_TEST

Non-invasive diagnostic techniques will screen subjects in primary care setting for the existence of Glaucoma and categorised them in a binary system: referrable vs non-referrable to a Hospital-based Glaucoma Clinic

AI-enhanced Retinography-based screening; OCT-based screening

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects age between 55 to 65 years old registered in the primary care area of either ACES Lisbon Norte (Lisbon arm) or in the area of ACES Alto Minho (Minho arm)
• willingness to sign an informed consent for the screening process

You may not qualify if:

• \- none
• Poor quality in screening image will be included in the intention to treat analysis, but excluded from the diagnostic comparator outcome.
• Patients with a known glaucoma diagnosis will not be excluded from the screening

Sponsors & Collaborators

• Centro Hospitalar Universitário Lisboa Norte: lead
• Unidade Local de Saúde do Alto Minho: collaborator
• ACES Lisboa Norte: collaborator
• Equipa Regional dos Programas de Rastreio da Região de Saúde de Lisboa e Vale do Tejo: collaborator
• ACES Alto Minho: collaborator

Study Sites (3)

Equipa Regional dos Programas de Rastreio da Região de Saúde de Lisboa e Vale do Tejo

Lisbon, 1500, Portugal

Location

Centro Hospitalar Lisbon Norte

Lisbon, 1649-028, Portugal

Location

Unidade Local Saude Alto Minho

Viana do Castelo, 4904-858, Portugal

Location

Related Publications (3)

• US Preventive Services Task Force; Mangione CM, Barry MJ, Nicholson WK, Cabana M, Chelmow D, Coker TR, Davis EM, Donahue KE, Epling JW Jr, Jaen CR, Krist AH, Kubik M, Li L, Ogedegbe G, Pbert L, Ruiz JM, Simon MA, Stevermer J, Wong JB. Screening for Primary Open-Angle Glaucoma: US Preventive Services Task Force Recommendation Statement. JAMA. 2022 May 24;327(20):1992-1997. doi: 10.1001/jama.2022.7013.

  PMID: 35608574 BACKGROUND

• 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

• Sousa DC, Leal I, Nascimento N, Marques-Neves C, Tuulonen A, Abegao Pinto L. Use of Ocular Hypotensive Medications in Portugal: PEM Study: A Cross-sectional Nationwide Analysis. J Glaucoma. 2017 Jun;26(6):571-576. doi: 10.1097/IJG.0000000000000668.

  PMID: 28368997 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Luis Abegão Pinto, MD, PhD

  Centro Hospitalar Universitário Lisboa Norte

  STUDY CHAIR

• Sérgio Azevedo, MD

  Unidade Local Saude Alto Minho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two physicians (unrelated to any recruiting center) will have access to pseudonymized data, masked to both screening and hospital decisions.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Two models of population-based glaucoma screening will be tested. Lisbon center will conduct screening using an Artificial-Intelligence software based on optic disc centered retinographies. The Minho center will conduct screening based on OCT-based findings on the retinal nerve fibre layer thickness (RNFL)

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 25, 2023
• Study Start: April 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)