An interventional study of Fundus Picture AI testing in Glaucoma and Diabetic Retinopathy, sponsored by Centro Hospitalar Universitário Lisboa Norte. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Centro Hospitalar Universitário Lisboa Norte · Not applicable, Interventional, and Diagnostic
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
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.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Centro Hospitalar Universitário Lisboa Norte is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Diagnostic Test: Fundus Picture AI testing
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)
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
Time frame: Duration of the study - 3 weeks
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
Time frame: After the study - 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar Universitário Lisboa Norte