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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.
Sponsor study identifier
observational
550
1 country
1
Study Start
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2023
Actual (reported)January 25, 2024
Actual (reported)April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
Through study completion, an average of 1 year
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of gold standard printed tests and computerised versions
Comparison of gold standard printed tests and computerised versions
Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust
St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
Alistair Laidlaw, MD FRCOphth
St Thomas' Hospital, London
First Submitted
October 25, 2023
First Posted
January 25, 2024
Study Start
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2025
Estimated (date passed)Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
Comparison of measurements made with the trial computerised test to the trial gold standard printed test
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 18, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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