Nctid:
NCT06224751
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000550", "term"=>"Amblyopia"}, {"id"=>"D000014786", "term"=>"Vision Disorders"}, {"id"=>"D000015354", "term"=>"Vision, Low"}, {"id"=>"D000008268", "term"=>"Macular Degeneration"}], "ancestors"=>[{"id"=>"D000012162", "term"=>"Retinal Degeneration"}, {"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000012678", "term"=>"Sensation Disorders"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M11260", "name"=>"Macular Degeneration", "asFound"=>"Macular Degeneration", "relevance"=>"HIGH"}, {"id"=>"M18042", "name"=>"Vision, Low", "asFound"=>"Visual Impairment", "relevance"=>"HIGH"}, {"id"=>"M3891", "name"=>"Amblyopia", "asFound"=>"Amblyopia", "relevance"=>"HIGH"}, {"id"=>"M17530", "name"=>"Vision Disorders", "asFound"=>"Visual Impairment", "relevance"=>"HIGH"}, {"id"=>"M14997", "name"=>"Retinal Degeneration", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M15490", "name"=>"Sensation Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>550}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-15", "studyFirstSubmitDate"=>"2023-10-25", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"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", "description"=>"The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units."}, {"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", "description"=>"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."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Visual acuity", "Visual function", "Ocular disease"], "conditions"=>["Visual Impairment", "Amblyopia", "Macular Degeneration", "Ophthalmic Disease"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nThere 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.\n\nThe aims of this two year linked program are to:\n\nPart 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.\n\nPart B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.\n\nAll 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"3 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients attending the outpatient eye clinics at St Thomas' Hospital NHS Foundation Trust", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.\n* Patients able to understand the information sheet, and willing and able to give informed consent to participate.\n* Patients with visual function ranging from normal to severely impaired.\n* Willing and able to comply with the visual function testing protocol.\n* Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).\n\nFor 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.\n\nExclusion Criteria:\n\n* Unwilling or unable to comply with the visual function testing protocol.\n* Unwilling or unable to give informed consent.\n* Unwilling to participate.\n* In other research trials."}, "identificationModule"=>{"nctId"=>"NCT06224751", "acronym"=>"CVTV", "briefTitle"=>"Developing Better Computerised Vision Tests (CVTV)", "organization"=>{"class"=>"OTHER", "fullName"=>"Guy's and St Thomas' NHS Foundation Trust"}, "officialTitle"=>"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.", "orgStudyIdInfo"=>{"id"=>"277317"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Near logMAR letter acuity", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Near logMAR letter acuity"]}, {"label"=>"Near logMAR word acuity", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Near LogMAR word acuity"]}, {"label"=>"Letter Contrast Sensitivity", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Letter Contrast Sensitivity"]}, {"label"=>"Vanishing Optotype Sloan letters", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Vanishing Optotype Sloan Letters"]}, {"label"=>"Auckland Optotypes/Auckland Vanishing Optotypes", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Auckland Optotype/Auckland Vanishing Optotypes"]}, {"label"=>"Low contrast letter acuity", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Low Contrast Letter Acuity"]}, {"label"=>"Red Green Stereoacuity", "description"=>"Comparison of measurements made with the trial computerised test to the trial gold standard printed test", "interventionNames"=>["Diagnostic Test: Red Green Stereoacuity"]}], "interventions"=>[{"name"=>"Near logMAR letter acuity", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Near logMAR letter acuity"]}, {"name"=>"Near LogMAR word acuity", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Near logMAR word acuity"]}, {"name"=>"Red Green Stereoacuity", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Red Green Stereoacuity"]}, {"name"=>"Auckland Optotype/Auckland Vanishing Optotypes", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Auckland Optotypes/Auckland Vanishing Optotypes"]}, {"name"=>"Vanishing Optotype Sloan Letters", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Vanishing Optotype Sloan letters"]}, {"name"=>"Letter Contrast Sensitivity", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Letter Contrast Sensitivity"]}, {"name"=>"Low Contrast Letter Acuity", "type"=>"DIAGNOSTIC_TEST", "description"=>"Comparison of gold standard printed tests and computerised versions", "armGroupLabels"=>["Low contrast letter acuity"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"London", "status"=>"RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Abigail Orr", "role"=>"CONTACT", "email"=>"eyeresearch@gstt.nhs.uk"}], "facility"=>"St Thomas' Hospital NHS Foundation Trust", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "centralContacts"=>[{"name"=>"Abigail Orr, BSc", "role"=>"CONTACT", "email"=>"eyeresearch@gstt.nhs.uk", "phone"=>"020 7188 4885"}], "overallOfficials"=>[{"name"=>"Alistair Laidlaw, MD FRCOphth", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"St Thomas' Hospital, London"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Guy's and St Thomas' NHS Foundation Trust", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"King's College London", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
