Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552247
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Glaucoma Algorithm Validation Study in African Population - the MAGIC Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation Study of an Artificial Algorithm for Glaucoma Detection in an African Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGIC
Brief 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
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 algorithms 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 Mozambiques capital will be screened using these AI algorithms and validated using clinical standard as ground truth
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 Mozambiques capital will be screened using these AI algorithms and validated using clinical standard as ground truth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None