Glaucoma Portugal Screening Trial

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

Interventions

DIAGNOSTIC_TEST

Glaucoma Screening

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

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Minho

  collaborator OTHER

• ACES Lisboa Norte

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• ACES Alto Minho

  collaborator UNKNOWN

• Centro Hospitalar Universitário Lisboa Norte

  lead OTHER

Principal Investigators

• Luis Abegão Pinto, MD, PhD · Centro Hospitalar Universitário Lisboa Norte

• Sérgio Azevedo, MD · Unidade Local Saude Alto Minho

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-13

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Portugal

Study Locations