GlaucomaMAGICNCT06552247
Glaucoma Algorithm Validation Study in African Population - the MAGIC Study
A study testing Fundus Picture AI testing in people with Glaucoma and Diabetic Retinopathy, run by Centro Hospitalar Universitário Lisboa Norte.
Trial summary
Artificial Intelligence (AI) algorithms require validation in a variety of populations to ensure widespread clinical applicability. In Ophthalmology, AI algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Diabetic Retinopathy
- What is being tested?
- Fundus Picture AI testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2024to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects age above 18 years old presenting at the Eye Unit
- 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
No sites are listed yet.
About this study
Official title: Validation Study of an Artificial Algorithm for Glaucoma Detection in an African Population
Artificial Intelligence (AI) algorithms require validation in a variety of populations to ensure widespread clinical applicability. In Ophthalmology, AI algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.
A small scale validation study in consecutive patients in a large Eyesore unit in Mozambique will be performed to determine the diagnostic ability of these AI softwares in this population
Read the detailed description
Artificial Intelligence (AI) algorithm's are the next frontier in medical management, usually meant to improve diagnostic capabilities and to optimize the existing resources. They are particularly relevant in settings where there is a lack of specialised Human Resources such as physicians.
Ensuring these algorithms can be used in a wide population is therefore crucial to clinical implementation. Validation studies in specific segments of populations are needed to ensure all patients are represented and the results are therefore reliable. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.
A pilot study for validation of an AI algorithm for Glaucoma and Diabetic Retinopathy will be done for the MONA G-RISK® and diabetic retinopathy. Consecutive patients from a large Eye Unit in Mozambique's capital will be screened using these AI algorithms and validated using clinical standard as ground truth.
- Conditions
- Glaucoma, Diabetic Retinopathy
- Being tested
- Fundus Picture AI testing
- Keywords
- Artificial Intelligence, Validation, Screening
- Medical subject headings
- Glaucoma, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus Picture AI testingDiagnostic test
G-Risk AI algorithm will assess the optic disc centered fundus picture and determine whether or not there is a need for referrable based on a pre-determined threshold (>=0.73)
| Study group | Role | What they receive |
|---|---|---|
| AI-based fundus picture screening | Experimental | Volunteers will performed a full study visit as part of their regular Ophthalmology assessment. This will include a fundus picture, an Optic-disc entered OCT, a Visual Field exam and a clinical examination by a clinical expert.
Fundus picture will be assessed by an AI algorithm (G-Risk) and labelled with referral vs non-referrable and compared with the clinical gold standard Receives: Diagnostic Test: Fundus Picture AI testing |
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 - 3 weeks
Secondary outcomes (1)
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: After the study - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start14 Aug 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm. Consecutive patients in a general ophthalmology consultation will be offered intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário Lisboa Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Agarwal's Eye Hospital
- Responsible party
- Principal investigator, Luis Abegao Pinto, Centro Hospitalar Universitário Lisboa Norte
- Investigators
- Joana Ferreira, MD, PhD, Study director, ULS Santa MariaAmelia Buque, MD, Study director, Dr. Agarwal Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552247
- Sponsor's protocol ID
- Collaboration Mozambique 2
- Acronym
- MAGIC
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of an Artificial Algorithm for Glaucoma Detection in an African Population
- ClinicalTrials.gov ID
- NCT06552247
- Acronym / sponsor ID
- MAGIC / Collaboration Mozambique 2
- Conditions
- Glaucoma, Diabetic Retinopathy
- Keywords
- Artificial Intelligence, Validation, Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitário Lisboa NorteUniversity, hospital or other
- Collaborators
- Dr. Agarwal's Eye Hospital
- Study start
- 14 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 13 Aug 2024 (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.
Artificial Intelligence (AI) algorithms require validation in a variety of populations to ensure widespread clinical applicability. In Ophthalmology, AI algorithms are reaching maturity in diagnosis such as diabetic retinopathy and glaucoma. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.
A small scale validation study in consecutive patients in a large Eyesore unit in Mozambique will be performed to determine the diagnostic ability of these AI softwares in this population
Detailed description
Artificial Intelligence (AI) algorithm's are the next frontier in medical management, usually meant to improve diagnostic capabilities and to optimize the existing resources. They are particularly relevant in settings where there is a lack of specialised Human Resources such as physicians.
Ensuring these algorithms can be used in a wide population is therefore crucial to clinical implementation. Validation studies in specific segments of populations are needed to ensure all patients are represented and the results are therefore reliable. Higher-at-risk subjects of African descent are nevertheless usually under-represented in training datasets and therefore unclear about representativity.
A pilot study for validation of an AI algorithm for Glaucoma and Diabetic Retinopathy will be done for the MONA G-RISK® and diabetic retinopathy. Consecutive patients from a large Eye Unit in Mozambique's capital will be screened using these AI algorithms and validated using clinical standard as ground truth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm. Consecutive patients in a general ophthalmology consultation will be offered intervention
| Arm | Type | Receives |
|---|---|---|
| AI-based fundus picture screening | Experimental | Diagnostic Test: Fundus Picture AI testingVolunteers will performed a full study visit as part of their regular Ophthalmology assessment. This will include a fundus picture, an Optic-disc entered OCT, a Visual Field exam and a clinical examination by a clinical expert. Fundus picture will be assessed by an AI algorithm (G-Risk) and labelled with referral vs non-referrable and compared with the clinical gold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects age above 18 years old presenting at the Eye Unit
- 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 |
|---|---|---|
| Fundus Picture AI testingG-Risk AI algorithm will assess the optic disc centered fundus picture and determine whether or not there is a need for referrable based on a pre-determined threshold (>=0.73) | Diagnostic test | AI-based fundus picture screening |
Primary outcome
Diagnostic agreement between referring decision and reading center decision
Time frame: Duration of the study - 3 weeks
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
1 secondary outcome
Level of agreement (in %) between AI-risk score and human-based assessment of disease severity
Time frame: After the study - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Joana Ferreira, MD, PhD study director
ULS Santa Maria
Amelia Buque, MD study director
Dr. Agarwal Eye Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fundus Picture AI testing in people with Glaucoma and Diabetic Retinopathy, run by Centro Hospitalar Universitário Lisboa Norte.
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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Luis Abegao Pinto, MD, PhD (+351 217 805 000, abegao.pinto@ulssm.min-saude.pt), or a site near the patient. 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 - 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.