Developing Better Computerised Vision Tests (CVTV)

Macular Degeneration Clinical Trial

— CVTV  

Official title:

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 Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224751
• Other study ID #: 277317
• Status: Recruiting
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Abigail Orr, BSc
• Phone: 020 7188 4885
• Email: eyeresearch[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia
• Macular Degeneration
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Diagnostic Test:
• Near logMAR letter acuity
Comparison of gold standard printed tests and computerised versions
• Near LogMAR word acuity
Comparison of gold standard printed tests and computerised versions
• Red Green Stereoacuity
Comparison of gold standard printed tests and computerised versions
• Auckland Optotype/Auckland Vanishing Optotypes
Comparison of gold standard printed tests and computerised versions
• Vanishing Optotype Sloan Letters
Comparison of gold standard printed tests and computerised versions
• Letter Contrast Sensitivity
Comparison of gold standard printed tests and computerised versions
• Low Contrast Letter Acuity
Comparison of gold standard printed tests and computerised versions

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test agreement between the computerised vision measurement test and the gold standard hard copy test.	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
Primary	Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.	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