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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06877988
Enrollment
400
Registered
2025-03-14
Start date
2024-06-27
Completion date
2026-03-31
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Impairment

Keywords

Visual impairment, Community Screening, Randomized Controlled Trial (RCT), Artificial Intelligence (AI)

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.

Interventions

DEVICEAI

Retinal photography-based deep learning algorithm for detection of disease-related visual impairment cases

Sponsors

Singapore Eye Research Institute
Lead SponsorOTHER
Institute of High Performance Computing (IHPC), A*STAR Research Institutes
CollaboratorUNKNOWN
National University Polyclinics, Singapore
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Individuals aged 50 years old and above.

Exclusion criteria

* Individuals aged below 50 years old.

Design outcomes

Primary

MeasureTime frameDescription
Performance of AVIRI on the detection of visual impairmentthrough study completion, an average 1 yearThe 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

MeasureTime frameDescription
Operational efficiencythrough study completion, an average 1 yearEvaluation includes (i) average screening time per patient and (ii) average number of patients screened per session.
Patient acceptabilitythrough study completion, an average 1 yearPatient Acceptability is assessed via a 6-item questionnaire (4-point Likert scale: 'Satisfaction' or 'Likelihood') administered by trained coordinators.
Perceptions of feasibilitythrough study completion, an average 1 yearPerceptions 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 modelthrough study completion, an average 1 yearResearchers 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.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026