Glaucoma Algorithm Validation Study in African Population - the MAGIC Study

NCT06552247 | Not Yet Recruiting

• 1 other identifier: Collaboration Mozambique 2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Glaucoma; Diabetic Retinopathy

Keywords

Artificial Intelligence; Validation; Screening

Outcome Measures

Primary Outcomes (1)

• 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

  Duration of the study - 3 weeks

Secondary Outcomes (1)

• Level of agreement (in %) between AI-risk score and human-based assessment of disease severity

  After the study - 6 months

Study Arms (1)

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

Diagnostic Test: Fundus Picture AI testing

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)

AI-based fundus picture screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects age above 18 years old presenting at the Eye Unit
• willingness to sign an informed consent for the screening process

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar Universitário Lisboa Norte: lead
• Dr. Agarwal's Eye Hospital: collaborator

MeSH Terms

Conditions

Glaucoma; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Joana Ferreira, MD, PhD

  ULS Santa Maria

  STUDY DIRECTOR

• Amelia Buque, MD

  Dr. Agarwal Eye Hospital

  STUDY DIRECTOR

Central Study Contacts

Luis Abegao Pinto, MD, PhD

CONTACT

+351 217 805 000; abegao.pinto@ulssm.min-saude.pt

Quirina Tavares Ferreira, PhD

CONTACT

+351 217 805 000; quirina.ferreira@ulssm.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator

Model Details: Single arm. Consecutive patients in a general ophthalmology consultation will be offered intervention

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 14, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share