Nctid:
NCT06221592
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009216", "term"=>"Myopia"}, {"id"=>"D000047728", "term"=>"Myopia, Degenerative"}], "ancestors"=>[{"id"=>"D000012030", "term"=>"Refractive Errors"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M12168", "name"=>"Myopia", "asFound"=>"Myopia", "relevance"=>"HIGH"}, {"id"=>"M25848", "name"=>"Myopia, Degenerative", "asFound"=>"Myopia, Progressive", "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"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>252}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-28", "studyFirstSubmitDate"=>"2023-12-17", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Axial length", "timeFrame"=>"2 years", "description"=>"The change of axial length."}], "secondaryOutcomes"=>[{"measure"=>"Subjective refraction equivalent spherical", "timeFrame"=>"2 years", "description"=>"The change of Subjective refraction equivalent spherical"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Myopia, Progressive"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"14 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age: 6-14 years old;\n2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D\\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;\n3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;\n4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.\n\nExclusion Criteria:\n\n1. Diagnosed constant strabismus;\n2. Diagnosed pathological myopia;\n3. Other congenital eye diseases;\n4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project."}, "identificationModule"=>{"nctId"=>"NCT06221592", "briefTitle"=>"Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai Eye Disease Prevention and Treatment Center"}, "officialTitle"=>"Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control", "orgStudyIdInfo"=>{"id"=>"QX-2023-A-03"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Full axis multi-point defocus spectacle lenses", "interventionNames"=>["Device: defocus spectacle lenses"]}, {"type"=>"EXPERIMENTAL", "label"=>"Innovative micro defocus spectacle lenses", "interventionNames"=>["Device: defocus spectacle lenses"]}, {"type"=>"EXPERIMENTAL", "label"=>"Circular multi-point optical micro transparent defocus spectacle lenses", "interventionNames"=>["Device: defocus spectacle lenses"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"High non spherical micro transparent defocus spectacle lenses", "interventionNames"=>["Device: defocus spectacle lenses"]}], "interventions"=>[{"name"=>"defocus spectacle lenses", "type"=>"DEVICE", "description"=>"To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.", "armGroupLabels"=>["Circular multi-point optical micro transparent defocus spectacle lenses", "Full axis multi-point defocus spectacle lenses", "High non spherical micro transparent defocus spectacle lenses", "Innovative micro defocus spectacle lenses"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200050", "city"=>"Shanghai", "state"=>"Shanghai", "country"=>"China", "facility"=>"Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai Eye Disease Prevention and Treatment Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
