NCT06224751

Developing Better Computerised Vision Tests (CVTV)

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 3 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Visual Impairment
• Amblyopia
• Macular Degeneration
• Ophthalmic Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Near logMAR letter acuity	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Near LogMAR word acuity	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Red Green Stereoacuity	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Auckland Optotype/Auckland Vanishing Optotypes	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Vanishing Optotype Sloan Letters	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Letter Contrast Sensitivity	Comparison of gold standard printed tests and computerised versions
DIAGNOSTIC_TEST	Low Contrast Letter Acuity	Comparison of gold standard printed tests and computerised versions

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-01-25
• Last updated: 2024-03-18

Locations

1 site across 1 country: United Kingdom