Developing Better Computerised Vision Tests (CVTV)

G

Guy's and St Thomas' NHS Foundation Trust

Status

Enrolling

Conditions

Ophthalmic Disease
Macular Degeneration
Amblyopia
Visual Impairment

Treatments

Diagnostic Test: Vanishing Optotype Sloan Letters
Diagnostic Test: Near LogMAR word acuity
Diagnostic Test: Letter Contrast Sensitivity
Diagnostic Test: Near logMAR letter acuity
Diagnostic Test: Red Green Stereoacuity
Diagnostic Test: Auckland Optotype/Auckland Vanishing Optotypes
Diagnostic Test: Low Contrast Letter Acuity

Study type

Observational

Funder types

Other

Identifiers

NCT06224751
277317

Details and patient eligibility

About

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.

Enrollment

550 estimated patients

Sex

All

Ages

3 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

550 participants in 7 patient groups

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

Trial contacts and locations

1

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Central trial contact

Abigail Orr, BSc

Data sourced from clinicaltrials.gov

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