NCT06552247

Glaucoma Algorithm Validation Study in African Population - the MAGIC Study

Validation Study of an Artificial Algorithm for Glaucoma Detection in an African Population

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centro Hospitalar Universitário Lisboa Norte · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Glaucoma
• Diabetic Retinopathy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-08-14
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-08-13
• Last updated: 2024-08-13