Clinical trial NCT06224751: Developing Better Computerised Vision Tests (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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visual Impairment
Amblyopia
Macular Degeneration
Ophthalmic Disease
Keywords: Visual acuity
Visual function
Ocular disease
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2024-01-25
Enrollment: 550
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the outpatient eye clinics at St Thomas' Hospital 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Test agreement between the computerised vision measurement test and the gold standard hard copy test.
timeFrame: Through study completion, an average of 1 year
measure: Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital NHS Foundation Trust
Study officials:
affiliation: St Thomas' Hospital, London
name: Alistair Laidlaw, MD FRCOphth
role: PRINCIPAL_INVESTIGATOR
References: