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

March 10, 2026 updated by: Tham Yih Chung, Singapore Eye Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Clarine Ho
  • Phone Number: +65 85112990

Study Locations

  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, 648201
        • Pioneer Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals aged 50 years old and above.

Exclusion Criteria:

  • Individuals aged below 50 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-assisted
Participants will undergo visual impairment screening using AVIRI model (AI for Disease-related Visual Impairment Screening Using Retinal Imaging). This intervention involves automated fundus image analysis through artificial intelligence to screen and identify individuals with high probability of visual impairment.
Device: AI
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)
No Intervention: Traditional
Participants will receive visual impairment screening using the traditional screening model, which involves optometrists performing initial assessments, followed by referral decisions based on manual fundus image evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average 1 year
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.
through study completion, an average 1 year
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.
through study completion, an average 1 year
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.
through study completion, an average 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore Eye Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National University Polyclinics, Singapore
Institute of High Performance Computing (IHPC), A*STAR Research Institutes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/2297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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