GlaucomaGlaucoma PoSTNCT05875090
Glaucoma Portugal Screening Trial
A study testing Glaucoma Screening in people with Glaucoma, run by Centro Hospitalar Universitário Lisboa Norte at 3 sites in Portugal.
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… Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Glaucoma Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 3 sitesPortugal
- Study dates
- 13 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Equipa Regional dos Programas de Rastreio da Região de Saúde de Lisboa e Vale do Tejo
Lisbon, 1500
Centro Hospitalar Lisbon Norte
Lisbon, 1649-028
Unidade Local Saude Alto Minho
Viana do Castelo, 4904-858
About this study
Official title: Screening Trial for Glaucomatous Optic Discs in Portugal
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).
Read more
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.
Read the detailed description
Glaucoma diagnosis is currently based on opportunistic case finding, which makes the case for up to 50% of patients remaining undiagnosed. Diagnostic technology has been deemed efficient in diagnosing, but cost and (hospital) location acts as a barrier for effective screening for this asymptomatic disease with a low population-based prevalence
Portuguese National Strategy for Visual Health, published in 2018 asks for a pilot study aimed at a one-time intervention at the primary care setting at the age of 60 years to do both an optic disc analysis and an intraocular pressure (IOP) measurement as a screening system for glaucoma
Two Portuguese centers have applied for this pilot. An urban-based center (Lisbon) and a countryside center (Minho) will conduct an invitation-based screening for those registered in their global primary care area. Age range was increased to 55 to 65 to capture a spectrum of data, enabling to later refine the target population.
Screening Intervention will be the same in both centers. Both will assess reasons for undergoing or rejecting screening and demographic and ophthalmological-related parameters, including glaucoma family history and a known personal glaucoma diagnosis. IOP will be non-invasively checked by rebound tonometry and optic disc retinographies will be performed on both centers. The Minho arm will additionally perform an optical coherence tomography (OCT) on all subjects.
Decision to refer will be made on one (or both) two findings:
- IOP of 24mmHg or higher
- referrable glaucoma
The Lisbon arm will use an Artificial intelligence (AI) system to rank the retinography findings into a binary referrable vs non-referrable system, based on a pre-defined threshold (0.73).
The Minho arm will base their referral on the existence of optical coherence tomography (OCT) retinal nerve fibre layer abnormality (defined as one sector thickness being outside normal limits)
Subjects flagged as referrable will be sent to the hospital Glaucoma Clinic, where functional and structural examinations will be performed and a standard of care clinical decision will be made by the glaucoma expert.
A reading center, with two masked experts, will be established to determine an unbiased ground truth for the comparison analysis. Reading center will conduct analysis on 3 tier level:
First round will include masked fundus pictures of all recruited subjects from both centers (both positive and negative referrals).
Second Round will include all subjects from Minho arm, who will have both fundus picture and OCT data.
Third round will include data analysis from all positive referrals from both arms, which includes all clinical data from the CRF plus all hospital exams (excluding clinical impression).
Outcomes of the reading center will be twofold:
- "Glaucoma diagnosis label"
- "normal"
- "glaucoma suspect"
- "definite glaucoma" (which implies a glaucomatous visual field) 2) Score (0-100) of likeliness of definitive glaucoma Disagreements on any category will be solved by a third masked referee (in the case of the scoring system, a difference larger than 10% would be considered a disagreement)
- Conditions
- Glaucoma
- Being tested
- Glaucoma Screening
- Keywords
- Screening
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma ScreeningDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Glaucoma Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of the study (8 months)
Secondary outcomes (6)
Comparison between level of agreement (with ground truth) from both screening models
Analysis on the differences in agreement between the AI-based referral and the OCT RNFL based referral in terms of the three possible outcomes by the reading center (normal; glaucoma suspect and definite glaucoma).
Measured: Duration of the study (8 months)
Level of performance of agreement by number of diagnostic testing
Reading center will conduct analysis on 3 tier level. First round will include masked fundus pictures of all recruited subjects from both centers (both positive and negative referrals). Second Round will include all subjects from Minho arm, who will have both fundus picture and OCT data. Final round will include data analysis from all positive referrals from both arms, which includes all clinical data from the CRF plus all hospital exams (excluding clinical impression).
Measured: Duration of the study (8 months)
Cost effective analysis of both screening models
Cost effective analysis will be performed on each arm comparing direct screening costs, stage of visual impairment of patients detected through screening and the opportunity saving by the screening compared to a standard case-finding scenario (literature reference).
Measured: Duration of the study (8 months)
Subjects parameters associated with positive screening
Analysis will be performed to explore a priori subjects characteristics that could be associated with a positive screening results (such as age, ethnic background, family history). Statistical models will be made to identify target population more likely to benefit from screening
Measured: Duration of the study (8 months)
Parameters associated with accepting screening system by the patients
Analysis will be done on all contacted patients (including the ones who did not accept to undergo screening) to identify which are the populations less likely to enter a screening circuit
Measured: Duration of the study (8 months)
Level of agreement (in %) between AI-risk score and human-based assessment of disease severity
Reading center risk score of disease severity (ranked from 0 to 100) will be compared to the AI-based disease score. This will be done separately in each of the 3 categories (normal; glaucoma suspect; glaucoma). Analysis of this score would help refine clinical risk (high risk vs low risk patients) of each category. Exploratory analysis will be made to determine the added value of including this risk score in refining AI-based referral
Measured: Duration of the study (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário Lisboa Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Minho, ACES Lisboa Norte, Equipa Regional dos Programas de Rastreio da Região de Saúde de Lisboa e Vale do Tejo, ACES Alto Minho
- Responsible party
- Principal investigator, Luis Abegao Pinto, Centro Hospitalar Universitário Lisboa Norte
- Investigators
- Luis Abegão Pinto, MD, PhD, Study chair, Centro Hospitalar Universitário Lisboa NorteSérgio Azevedo, MD, Study chair, Unidade Local Saude Alto Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875090
- Sponsor's protocol ID
- 38/23
- Acronym
- Glaucoma PoST
- Status last verified
- Jun 2024
- First submitted
- 13 Apr 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35608574Hemelings 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.
PubMed 31344328Sousa 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.
PubMed 28368997
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Trial for Glaucomatous Optic Discs in Portugal
- ClinicalTrials.gov ID
- NCT05875090
- Acronym / sponsor ID
- Glaucoma PoST / 38/23
- Conditions
- Glaucoma
- Keywords
- Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitário Lisboa NorteUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Minho, ACES Lisboa Norte, Equipa Regional dos Programas de Rastreio da Região de Saúde de Lisboa e Vale do Tejo, ACES Alto Minho
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glaucoma diagnosis is currently based on opportunistic case finding, which makes the case for up to 50% of patients remaining undiagnosed. Diagnostic technology has been deemed efficient in diagnosing, but cost and (hospital) location acts as a barrier for effective screening for this asymptomatic disease with a low population-based prevalence
Portuguese National Strategy for Visual Health, published in 2018 asks for a pilot study aimed at a one-time intervention at the primary care setting at the age of 60 years to do both an optic disc analysis and an intraocular pressure (IOP) measurement as a screening system for glaucoma
Two Portuguese centers have applied for this pilot. An urban-based center (Lisbon) and a countryside center (Minho) will conduct an invitation-based screening for those registered in their global primary care area. Age range was increased to 55 to 65 to capture a spectrum of data, enabling to later refine the target population.
Screening Intervention will be the same in both centers. Both will assess reasons for undergoing or rejecting screening and demographic and ophthalmological-related parameters, including glaucoma family history and a known personal glaucoma diagnosis. IOP will be non-invasively checked by rebound tonometry and optic disc retinographies will be performed on both centers. The Minho arm will additionally perform an optical coherence tomography (OCT) on all subjects.
Decision to refer will be made on one (or both) two findings:
- IOP of 24mmHg or higher
- referrable glaucoma
The Lisbon arm will use an Artificial intelligence (AI) system to rank the retinography findings into a binary referrable vs non-referrable system, based on a pre-defined threshold (0.73).
The Minho arm will base their referral on the existence of optical coherence tomography (OCT) retinal nerve fibre layer abnormality (defined as one sector thickness being outside normal limits)
Subjects flagged as referrable will be sent to the hospital Glaucoma Clinic, where functional and structural examinations will be performed and a standard of care clinical decision will be made by the glaucoma expert.
A reading center, with two masked experts, will be established to determine an unbiased ground truth for the comparison analysis. Reading center will conduct analysis on 3 tier level:
First round will include masked fundus pictures of all recruited subjects from both centers (both positive and negative referrals).
Second Round will include all subjects from Minho arm, who will have both fundus picture and OCT data.
Third round will include data analysis from all positive referrals from both arms, which includes all clinical data from the CRF plus all hospital exams (excluding clinical impression).
Outcomes of the reading center will be twofold:
- "Glaucoma diagnosis label"
- "normal"
- "glaucoma suspect"
- "definite glaucoma" (which implies a glaucomatous visual field) 2) Score (0-100) of likeliness of definitive glaucoma Disagreements on any category will be solved by a third masked referee (in the case of the scoring system, a difference larger than 10% would be considered a disagreement)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| AI-enhanced Retinography-based screening | Experimental | Diagnostic Test: Glaucoma ScreeningScreening 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 |
| OCT-based screening | Active comparator | Diagnostic Test: Glaucoma ScreeningScreening 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 |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glaucoma ScreeningNon-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 | Diagnostic test | AI-enhanced Retinography-based screening, OCT-based screening |
Primary outcome
Diagnostic agreement between referring decision and reading center decision
Time frame: Duration of the study (8 months)
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
6 secondary outcomes
Comparison between level of agreement (with ground truth) from both screening models
Time frame: Duration of the study (8 months)
Level of performance of agreement by number of diagnostic testing
Time frame: Duration of the study (8 months)
Cost effective analysis of both screening models
Time frame: Duration of the study (8 months)
Subjects parameters associated with positive screening
Time frame: Duration of the study (8 months)
Parameters associated with accepting screening system by the patients
Time frame: Duration of the study (8 months)
Level of agreement (in %) between AI-risk score and human-based assessment of disease severity
Time frame: Duration of the study (8 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 35608574US 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.
- Background: PubMed 31344328Hemelings 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.
- Background: PubMed 28368997Sousa 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Abegão Pinto, MD, PhD study chair
Centro Hospitalar Universitário Lisboa Norte
Sérgio Azevedo, MD study chair
Unidade Local Saude Alto Minho
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma Screening in people with Glaucoma, run by Centro Hospitalar Universitário Lisboa Norte at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement between referring decision and reading center decision (time frame: Duration of the study (8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.