An observational study in Visual Impairment, Amblyopia and Macular Degeneration, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 3 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 550 is above the median of 156 across 39 observational studies indexed under Amblyopia.
Browse Amblyopia studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
Compared within Amblyopia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vision Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Near logMAR letter acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Near LogMAR word acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Letter Contrast Sensitivity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Vanishing Optotype Sloan Letters
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Auckland Optotype/Auckland Vanishing Optotypes
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Low Contrast Letter Acuity
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Diagnostic Test: Red Green Stereoacuity
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Guy's and St Thomas' NHS Foundation Trust →