NCT06540001

Brief Summary

Visual acuity tests, commonly conducted in clinics and used for health screenings, are becoming more in demand due to an aging population. Current online self-eye check apps are limited as they don\'t accurately reflect true distance vision assessed in clinical settings. These tests, performed by trained personnel, are time-consuming and can cause delays in clinics. This project aims to develop an automated Visual Acuity (VA) station using AI technologies like speech-to-text and computer vision, hypothesizing that it can match the accuracy of manual assessments by clinic staff, thus potentially reducing waiting times and improving efficiency.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

July 27, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Visual acuity

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity with and without pinhole using Snellen letters and numbers

    Best corrected visual acuity will be expressed in metres (e.g. 6/6-1), and will be converted to LogMAR for analysis.

    1 year

Study Arms (1)

Patients will undergo both automated and manual visual acuity testing

EXPERIMENTAL

Patient will perform manual visual acuity first, then be guided to another room to have the visual acuity tested on the automated VA device

Device: Automated visual acuity

Interventions

The automated visual acuity device is developed in collaboration with Tan Tock Seng Hospital, Singapore Institute of Technology and Nanyang Technological University. It uses artificial intelligence for pose estimation and speech recognition to infer if the participant is reading the correct letters displayed on the screen.

Patients will undergo both automated and manual visual acuity testing

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age \>21 and able to give consent
  • Patients who have at least counting finger vision
  • Patients who is able to speak in an audible and clear voice
  • Patients who is able to use a digital device independently (e.g. handphone)

You may not qualify if:

  • Patients on wheelchair/ walking aids
  • Patients with hearing difficulties
  • Patients with speech difficulties
  • Patients who have cognitive impairment
  • Patients who are hemiplegic/ motor dysfunction
  • Patients who have vision worse than counting fingers
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kelvin Z Li., MBBS, MTech, FRCOphth

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 6, 2024

Study Start

August 1, 2024

Primary Completion

October 31, 2024

Study Completion

August 1, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share