Developing Better Computerised Vision Tests (CVTV)

Recruiting

• Conditions: Visual Impairment; Ophthalmic Disease; Amblyopia; Macular Degeneration
• Interventions: Diagnostic Test: Letter Contrast Sensitivity; Diagnostic Test: Auckland Optotype/Auckland Vanishing Optotypes; Diagnostic Test: Red Green Stereoacuity; Diagnostic Test: Near logMAR letter acuity; Diagnostic Test: Near LogMAR word acuity; Diagnostic Test: Vanishing Optotype Sloan Letters; Diagnostic Test: Low Contrast Letter Acuity

• Registration Number: NCT06224751
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Study Start: 2024-04
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.	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.
Test agreement between the computerised vision measurement test and the gold standard hard copy test.	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.

Trial Locations

Locations (1)

St Thomas' Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom