Developing Better Computerised Vision Tests (CVTV) (CVTV)

March 15, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

A Program to Develop Computerised Visual Function Tests for Cross Sectional Routine Clinical Practice and Long Term Monitoring to Detect Adverse Change in Visual Function.

Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available.

There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum.

The aims of this two year linked program are to:

Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these.

Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.

All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

550

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 Locations

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust

Description

Inclusion Criteria:

  • Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.
  • Patients able to understand the information sheet, and willing and able to give informed consent to participate.
  • Patients with visual function ranging from normal to severely impaired.
  • Willing and able to comply with the visual function testing protocol.
  • Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).

For Part B of the project which aims to develop and pilot a home monitoring application, only adult (18-99 years) subjects complying with the above who also own a suitable browser device will be recruited.

Exclusion Criteria:

  • Unwilling or unable to comply with the visual function testing protocol.
  • Unwilling or unable to give informed consent.
  • Unwilling to participate.
  • In other research trials.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Near logMAR letter acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Near logMAR letter acuity
Comparison of gold standard printed tests and computerised versions
Near logMAR word acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Near LogMAR word acuity
Comparison of gold standard printed tests and computerised versions
Letter Contrast Sensitivity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Letter Contrast Sensitivity
Comparison of gold standard printed tests and computerised versions
Vanishing Optotype Sloan letters
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Vanishing Optotype Sloan Letters
Comparison of gold standard printed tests and computerised versions
Auckland Optotypes/Auckland Vanishing Optotypes
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Auckland Optotype/Auckland Vanishing Optotypes
Comparison of gold standard printed tests and computerised versions
Low contrast letter acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Low Contrast Letter Acuity
Comparison of gold standard printed tests and computerised versions
Red Green Stereoacuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic test: Red Green Stereoacuity
Comparison of gold standard printed tests and computerised versions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test agreement between the computerised vision measurement test and the gold standard hard copy test.
Time Frame: Through study completion, an average of 1 year
The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units.
Through study completion, an average of 1 year
Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
Time Frame: Through study completion, an average of 1 year
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified in log units for each vision test used in this study.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

Investigators

  • Principal Investigator: Alistair Laidlaw, MD FRCOphth, St Thomas' Hospital, London

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 277317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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