Glaucoma Algorithm Validation Study in African Population - the MAGIC Study

Sponsor
Centro Hospitalar Universitário Lisboa Norte
Study ID
NCT06552247
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fundus Picture AI testing — DIAGNOSTIC_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 Details

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

Key Dates

First listed
Aug 13, 2024
Start date
Aug 14, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: AI-based fundus picture screening
    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

Primary Outcome Measure

Diagnostic agreement between referring decision and reading center decision [ Time Frame: Duration of the study - 3 weeks ]

Central Contacts

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