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NCT Number: NCT06877988

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pioneer Polyclinic

Singapore, 648201

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 50 years old and above.

Exclusion criteria

  • Individuals aged below 50 years old.

Treatment and study plan

AI

Device

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

Other names: AVIRI (AI for Disease-related Visual Impairment Screening Using Retinal Imaging)

Primary outcomes

  1. Performance of AVIRI on the detection of visual impairment

    Time frame: 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 outcomes

  1. Operational efficiency

    Time frame: through study completion, an average 1 year

    Evaluation includes (i) average screening time per patient and (ii) average number of patients screened per session.

  2. Patient acceptability

    Time frame: 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.

  3. Perceptions of feasibility

    Time frame: 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.

  4. Cost savings of implementing the AI-assisted screening model

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Singapore Eye Research Institute

Other

Collaborators

  • Institute of High Performance Computing (IHPC), A*STAR Research Institutes
  • National University Polyclinics, Singapore

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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