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Not yet recruitingNCT06540001AutoVAUpdated Aug 6, 2024

Development and Validation of an Automated Self-administered Visual Acuity System

An interventional study of Automated visual acuity in Visual Impairment, sponsored by Tan Tock Seng Hospital. Not yet recruiting. Open to participants aged 21 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Tan Tock Seng Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
21 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

Visual acuity is done as a routine eye check for the majority of eye patients in the clinic. It is also done as a screening test for pre-employment health checks and health screening. Patients can be checked for refractive errors, on a community level or screened for eye diseases, for those with chronic medical conditions. With the increasing burden of aging population and eye conditions, the number of patients in eye clinics will increase.

There are a few existing online applications that allow self-eye checks, however there are limitations. They are usually done at an intermediate distance, i.e. distance from phone to eye and does not accurately represent true distance vision. Distance vision is typically set at 4- 6m in a clinical setting.

A visual acuity test is administered by specially trained healthcare personnel, such as optometrists and patient service assistants, which is often time-consuming and labour intensive, where one-on-one attention is required. In addition, vision is subjective and re-testing may be required at times to ensure accurate vision assessment.

As the visual acuity test is the first clinical station patient goes to after registration, this leads to a bottleneck in workflow causes delays in the subsequent services and eventually increases patient waiting times in the clinics.

This project aims to develop and validate an automated Visual Acuity (VA) station through speech-to-text and computer vision technology in comparison to existing manual VA assessments.

We hypothesize that we are able to use artificial intelligence to understand patient\'s speech and posture to automate the visual acuity test. We also hypothesize that the automated visual acuity test is comparable to having VA checked manually by a clinic staff.

02

Conditions studied

  • Visual Impairment

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Keywords

  • Visual acuity
03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 244 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 108 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients on wheelchair/ walking aids
  2. Patients with hearing difficulties
  3. Patients with speech difficulties
  4. Patients who have cognitive impairment
  5. Patients who are hemiplegic/ motor dysfunction
  6. Patients who have vision worse than counting fingers
  7. Patients who are pregnant
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Patients will undergo both automated and manual visual acuity testing

    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

  • DeviceAutomated visual acuity

    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.

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2024; primary completion for Oct 2024, 2 months later.

Of 84 non-industry interventional studies with no phase under Vision Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's planned 2 months is below that.

Counting every sponsor, half of 94 studies reached it within 24 months; a quarter within 6 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2024
First posted
Aug 6, 2024
StartEst.
Aug 1, 2024
Primary completionEst.
Oct 31, 2024
CompletionEst.
Aug 1, 2025
Last update
Aug 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06540001
Collaborators
Singapore Institute of Technology, Nanyang Technological University, Lee Kong Chian School of Medicine, Nanyang Technological University
Responsible party
Li Zhenghao Kelvin (Consultant, Tan Tock Seng Hospital) — Principal investigator
First posted
Aug 6, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Aug 6, 2024

Study contacts

Kelvin Z Li., MBBS, MTech, FRCOphth
Contact
contact@ttsh.com.sg
+6562566011

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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