Developing Better Computerised Vision Tests (CVTV)

NCT ID: NCT06224751

Last Updated: 2024-03-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Visual Impairment Amblyopia Macular Degeneration Ophthalmic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Near logMAR letter acuity

Comparison of measurements made with the trial computerised test to the trial gold standard printed test

Near logMAR letter acuity

Intervention Type DIAGNOSTIC_TEST

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

Near LogMAR word acuity

Intervention Type DIAGNOSTIC_TEST

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

Letter Contrast Sensitivity

Intervention Type DIAGNOSTIC_TEST

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

Vanishing Optotype Sloan Letters

Intervention Type DIAGNOSTIC_TEST

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

Auckland Optotype/Auckland Vanishing Optotypes

Intervention Type DIAGNOSTIC_TEST

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

Low Contrast Letter Acuity

Intervention Type DIAGNOSTIC_TEST

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

Red Green Stereoacuity

Intervention Type DIAGNOSTIC_TEST

Comparison of gold standard printed tests and computerised versions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Near logMAR letter acuity

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Near LogMAR word acuity

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Red Green Stereoacuity

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Auckland Optotype/Auckland Vanishing Optotypes

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Vanishing Optotype Sloan Letters

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Letter Contrast Sensitivity

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Low Contrast Letter Acuity

Comparison of gold standard printed tests and computerised versions

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alistair Laidlaw, MD FRCOphth

Role: PRINCIPAL_INVESTIGATOR

St Thomas' Hospital, London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Thomas' Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abigail Orr, BSc

Role: CONTACT

020 7188 4885

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abigail Orr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

277317

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dual Wavelength OCT
NCT03843840 COMPLETED
Visual Frailty in Ageing
NCT06604104 RECRUITING