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

NCT ID: NCT06877988

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Visual Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AI

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI

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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 50 years old and above.

Exclusion Criteria

* Individuals aged below 50 years old.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of High Performance Computing (IHPC), A*STAR Research Institutes

UNKNOWN

Sponsor Role collaborator

National University Polyclinics, Singapore

OTHER

Sponsor Role collaborator

Singapore Eye Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Tham Yih Chung

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pioneer Polyclinic

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Kaeley Koh

Role: CONTACT

+65 90187381

Clarine Ho

Role: CONTACT

+65 85112990

Facility Contacts

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Wee Hian Tan

Role: primary

+65 98382446

Other Identifiers

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2024/2297

Identifier Type: -

Identifier Source: org_study_id

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