Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
550 participants
OBSERVATIONAL
2024-04-30
2025-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Near logMAR letter acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Near logMAR letter acuity
Comparison of gold standard printed tests and computerised versions
Near logMAR word acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Near LogMAR word acuity
Comparison of gold standard printed tests and computerised versions
Letter Contrast Sensitivity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Letter Contrast Sensitivity
Comparison of gold standard printed tests and computerised versions
Vanishing Optotype Sloan letters
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Vanishing Optotype Sloan Letters
Comparison of gold standard printed tests and computerised versions
Auckland Optotypes/Auckland Vanishing Optotypes
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Auckland Optotype/Auckland Vanishing Optotypes
Comparison of gold standard printed tests and computerised versions
Low contrast letter acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Low Contrast Letter Acuity
Comparison of gold standard printed tests and computerised versions
Red Green Stereoacuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Red Green Stereoacuity
Comparison of gold standard printed tests and computerised versions
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 give informed consent.
* Unwilling to participate.
* In other research trials.
3 Years
99 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Alistair Laidlaw, MD FRCOphth
Role: PRINCIPAL_INVESTIGATOR
St Thomas' Hospital, London
Locations
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St Thomas' Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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277317
Identifier Type: -
Identifier Source: org_study_id
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