Artificial Intelligence (AI) - Assisted Visual Impairment Screening Model: Community-based Implementation and Evaluation of Performance, Feasibility and Costs.

Not Applicable

Recruiting

• Conditions: Visual Impairment

• Registration Number: NCT06877988
• Lead Sponsor: Singapore Eye Research Institute

Brief Summary

The goal of this observational study is to evaluate the performance, operational efficiency, acceptability, feasibility, and cost-effectiveness of an AI-assisted screening model for visual impairment in a community setting. The main questions it aims to answer are:

* Can the AI-assisted screening model improve screening and referral accuracy compared to the current traditional screening approach?

* Does the AI-assisted model enhance operational efficiency and reduce healthcare costs in a community setting?

Researchers will compare the AI-assisted model with the current traditional screening approach to assess its impact on screening accuracy, operational efficiency, and cost-effectiveness.

Participants will:

* Undergo vision screening using either the AI-assisted model or the traditional model.

* Provide feedback on the acceptability of the screening approach.

* Contribute to evaluating the feasibility and costs associated with each screening method.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-27
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Individuals aged 50 years old and above.

Exclusion Criteria

• Individuals aged below 50 years old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Performance of AVIRI on the detection of visual impairment	through study completion, an average 1 year	The primary outcome is the detection performance for VI (refractive error-related and disease-related VI) and the rate of correct referral, with reference to the expert panels' diagnosis . To assess whether the new AI-assisted model has better referral accuracy than the current traditional model, the accuracy, AUC values, sensitivity, specificity and other performance metrics of the two models will be calculated and compared.

Secondary Outcome Measures

Name	Time	Method
Operational efficiency	through study completion, an average 1 year	Evaluation includes (i) average screening time per patient and (ii) average number of patients screened per session.
Patient acceptability	through study completion, an average 1 year	Patient Acceptability is assessed via a 6-item questionnaire (4-point Likert scale: 'Satisfaction' or 'Likelihood') administered by trained coordinators.
Perceptions of feasibility	through study completion, an average 1 year	Perceptions of feasibility is evaluated through at least two focus groups with optometrists and one with service providers will be conducted, guided by the Consolidated Framework for Implementation Research (CFIR). Discussions will explore barriers and facilitators influencing the AI screening model's adoption. Data will be inductively and deductively coded by two researchers using CFIR constructs; discrepancies resolved through consensus or a third researcher.
Cost savings of implementing the AI-assisted screening model	through study completion, an average 1 year	Researchers will quantify the incremental cost savings of implementing the AI-assisted screening model over the PSS model using an Activity Based Costing (ABC) approach that quantifies all non-sunk costs (including labor, materials and supplies, and amortized technology and space utility/ rental costs) required to conduct each assessment stratified by key activities of each screening model (e.g., conduct screening examinations, operationalize the AVIRI algorithm, on-site generation of test results etc.). Fixed costs will be amortized over the inputs' expected useful life (i.e. involved fixed assets' life expectancy). For the cost of clinical assessments, researchers will use non-subsidized bill sizes as these are expected to approximate actual costs.

Trial Locations

Locations (1)

Pioneer Polyclinic; 🇸🇬 Singapore, Singapore