Nctid:
NCT06234189
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009216", "term"=>"Myopia"}], "ancestors"=>[{"id"=>"D012030", "term"=>"Refractive Errors"}, {"id"=>"D005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M12168", "name"=>"Myopia", "asFound"=>"Myopia", "relevance"=>"HIGH"}, {"id"=>"M14872", "name"=>"Refractive Errors", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2024-04-30", "size"=>385656, "label"=>"Statistical Analysis Plan", "hasIcf"=>false, "hasSap"=>true, "filename"=>"SAP_000.pdf", "typeAbbrev"=>"SAP", "uploadDate"=>"2024-05-02T09:59", "hasProtocol"=>false}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>16}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-03-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-13", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-07", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Choroidal thickness", "timeFrame"=>"During 60 minutes", "description"=>"Thickness is measured in um"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Myopia"]}, "descriptionModule"=>{"briefSummary"=>"The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"10 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: \"Defocus Spectacle Lenses (DIMS) versus Orthokeratology lenses (OKL) for slowing myopia progression in children\" (ClinicalTrials.gov Identifier NCT05134935)\n* Myopia at the time of inclusion in the NISDO study: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes)\n* Anisometropia \\< 1,5 D cycloplegic spherical equivalent refractive error\n* Best corrected visual acuity (inclusive): 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)\n\nExclusion Criteria:\n\n* Manifest or intermittent squint\n* Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca\n* Previous eye surgery\n* Chronic eye disease demanding daily use of eye drops\n* Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses)"}, "identificationModule"=>{"nctId"=>"NCT06234189", "acronym"=>"TIDOCT", "briefTitle"=>"The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children", "organization"=>{"class"=>"OTHER", "fullName"=>"Vejle Hospital"}, "officialTitle"=>"The Immediate Effect of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) on the Choroid Thickness Using Swept Source-Optical Coherence Tomography (SS-OCT) on Children.", "orgStudyIdInfo"=>{"id"=>"TIDOCT"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)", "interventionNames"=>["Device: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)"]}], "interventions"=>[{"name"=>"Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)", "type"=>"DEVICE", "description"=>"30 minutes without DIMS and 30 minutes with DIMS", "armGroupLabels"=>["Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"7100", "city"=>"Vejle", "state"=>"Southern Denmark", "country"=>"Denmark", "facility"=>"The Ophthalmic department, Vejle Hospital", "geoPoint"=>{"lat"=>55.70927, "lon"=>9.5357}}], "overallOfficials"=>[{"name"=>"Lou-Ann Andersen", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Vejle Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Vejle Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
