UnknownNot Applicable

Glaucoma Portugal Screening Trial

Portugal6,000 participantsStarted 2023-04-13

Plain-language 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.

Who can participate

Age range

55 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: \- 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic agreement between referring decision and reading center decision

Timeframe: Duration of the study (8 months)

Trial details

NCT IDNCT05875090

SponsorCentro Hospitalar Universitário Lisboa Norte

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Glaucoma trials