Nctid:
NCT06224114
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012173", "term"=>"Retinitis"}, {"id"=>"D000012174", "term"=>"Retinitis Pigmentosa"}], "ancestors"=>[{"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000015785", "term"=>"Eye Diseases, Hereditary"}, {"id"=>"D000058499", "term"=>"Retinal Dystrophies"}, {"id"=>"D000012162", "term"=>"Retinal Degeneration"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}], "browseLeaves"=>[{"id"=>"M18042", "name"=>"Vision, Low", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M15008", "name"=>"Retinitis", "asFound"=>"Retinitis", "relevance"=>"HIGH"}, {"id"=>"M15009", "name"=>"Retinitis Pigmentosa", "asFound"=>"Retinitis Pigmentosa", "relevance"=>"HIGH"}, {"id"=>"M29107", "name"=>"Retinal Dystrophies", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M18339", "name"=>"Eye Diseases, Hereditary", "relevance"=>"LOW"}, {"id"=>"M14997", "name"=>"Retinal Degeneration", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"T4945", "name"=>"Retinitis Pigmentosa", "asFound"=>"Retinitis Pigmentosa", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Technicians responsible for study measurements, Chief Investigator (CI), Principal Investigator (PI) and collaborators will be masked to the treatment allocation. It is not possible for participants to be fully masked as they will know which wavelength (colour) of light they have been provided, but they will not be told which wavelength of light is the active intervention. Participants will be advised not to discuss the colour of light used with the masked technicians and study team members."}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-12", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Tritan Colour Contrast Threshold (CCT)", "timeFrame"=>"Measured at Day 0 and Day 28", "description"=>"Tritan CCT will be measured using the ChromaTest® platform, a software program which quantifies age-corrected tritan and protan CCT using a Modified Binary Search method. Tritan CCT test endpoint is a continuous variable (units: percentage)."}], "secondaryOutcomes"=>[{"measure"=>"Protan CCT", "timeFrame"=>"Measured at Day 0 and Day 28", "description"=>"Protan CCT will be measured using the ChromaTest® platform, a software program which quantifies age-corrected tritan and protan CCT using a Modified Binary Search method. Protan CCT test endpoint is a continuous variable (units: percentage)."}, {"measure"=>"LogMAR Visual Acuity (LogMAR VA)", "timeFrame"=>"Measured at Day 0 and Day 28", "description"=>"LogMAR VA will be measured on an electronic LogMAR acuity chart (Test Chart 2020, Thompson Software Solutions, UK), according to a forced-choice procedure."}, {"measure"=>"Proportion of participants losing ≥15 letters of LogMAR VA", "timeFrame"=>"Measured each day (Day 0 through Day 28)", "description"=>"Proportion of participants losing 15 letters of LogMAR VA or more at day 28 will be reported as a safety outcome."}, {"measure"=>"Compliance rate", "timeFrame"=>"Measured each day (Day 0 through Day 28)", "description"=>"Compliance rate of application of daily, 3-minute, at-home, participant administered coloured-light exposure is a secondary endpoint. This will be collected through completion of a participant diary."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Inherited eye disease", "Retinal dystrophy", "Retinitis Pigmentosa", "Visual impairment", "Photobiomodulation", "Mitochondrial Dysfunction"], "conditions"=>["Retinitis Pigmentosa"]}, "descriptionModule"=>{"briefSummary"=>"This study will assess the effect of 2 different colours of light on colour vision in adults with retinitis pigments (RP). Participants will be 18 years or above with a genetically confirmed molecular diagnosis of RP. After informed consent, participants will have their letter chart vision and colour vision measured in their study eye. They will then be they will be randomly allocated to one of 2 groups. The study team will not know which group they have been assigned to. Group 1 will be given a coloured-light hand-held torch and be asked to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Group 2 will be given a different colour hand-held torch and be asked to do the same. All participants will have their letter chart vision and colour vision measured at the end of study on day 28 (+ 7 days).", "detailedDescription"=>"This is a pilot, randomised, masked, single-site trial designed to assess the effect of coloured light exposure on cone contrast thresholds (CCT) in adults with RP.\n\n70 adults with typical RP in which the underlying genetic cause is known will be recruited from Moorfields Eye Hospital genetics service.\n\nFollowing informed consent, participants will be invited for a baseline study visit.\n\nAt a baseline visit, prior to any light exposure (day 0), participants will undergo Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) and CCT measurements performed by an experienced technician according to dedicated standard operating procedures. The order of testing will be as follows:\n\n* Study eye: LogMAR VA\n* Study eye: CCT (Tritan and Protan)\n\nAfter baseline assessments have been completed, participants will be randomised to the intervention (n=35) or control group (n=35) by a study nurse. All other study team members will be masked to group allocation.\n\nThe intervention group will be provided with a coloured torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. The control group will be provided with a different coloured torch and will be instructed to follow the same protocol. The specific colours have not be disclosed here to protect masking of the study. Participants will be asked to complete a paper diary each day to record whether light was applied, the time and duration of the application and the eye to which light was applied.\n\nThe end of trial visit will be scheduled on day 28 (+7 days). Participants will undergo LogMAR VA and CCT measurements by an experienced technician according to standard operating procedures (SOP). The order of testing will be as follows:\n\n* Study eye: LogMAR VA\n* Study eye: CCT (Tritan and Protan)"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Over 18 years old\n* Typical RP where the underlying genetic cause is known. This may include PRPF31, PRPF8, SNRNP200, RHO, RP1 \\[autosomal dominant\\] and USH2A, EYS \\[autosomal recessive\\]\n* VA of 0.30 LogMAR (6/12) or better in the study eye\n* Preserved foveal structure defined by intact outer retinal (ellipsoid zone) at the fovea on Optical Coherence Tomography (OCT) and a hyperfluorescent ring within the temporal vascular arcades on Fundus Autofluorescence (FAF) in the study eye\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Co-existing ocular pathology will be excluded; however, participants with macular oedema, a common pre-symptomatic manifestation of foveal involvement, will not be excluded\n* Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 6 months of study enrolment\n* Unwilling or able to provide written informed consent."}, "identificationModule"=>{"nctId"=>"NCT06224114", "acronym"=>"CLIRP", "briefTitle"=>"Coloured-light in Retinitis Pigmentosa.", "organization"=>{"class"=>"OTHER", "fullName"=>"University College, London"}, "officialTitle"=>"A Pilot, Randomised, Masked Study to Investigate the Effect of Coloured-light on Colour Contrast Thresholds in Retinitis Pigmentosa.", "orgStudyIdInfo"=>{"id"=>"161090"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Coloured light 1 group", "description"=>"Coloured light 1 group will be provided with a coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days.", "interventionNames"=>["Device: Coloured-light torch"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Coloured light 2 group", "description"=>"Coloured light 2 group will be provided with a different coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days.", "interventionNames"=>["Device: Different coloured-light torch"]}], "interventions"=>[{"name"=>"Coloured-light torch", "type"=>"DEVICE", "description"=>"Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a coloured-light torch to the study eye.", "armGroupLabels"=>["Coloured light 1 group"]}, {"name"=>"Different coloured-light torch", "type"=>"DEVICE", "description"=>"Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a different coloured-light torch to the study eye.", "armGroupLabels"=>["Coloured light 2 group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"London", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Hannah Dunbar, PhD", "role"=>"CONTACT"}], "facility"=>"Moorfields Eye Hospital NHS Foundation Trust", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "centralContacts"=>[{"name"=>"Pushpsen Joshi", "role"=>"CONTACT", "email"=>"uclh.randd@nhs.net", "phone"=>"0203 447 5369"}], "overallOfficials"=>[{"name"=>"Hannah Dunbar, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"UCL Institute of Ophthalmology"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Data will not be shared with other researchers"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University College, London", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
