Nctid:
NCT06233409
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000057112", "term"=>"Corneal Perforation"}], "ancestors"=>[{"id"=>"D000065306", "term"=>"Corneal Injuries"}, {"id"=>"D000005131", "term"=>"Eye Injuries"}, {"id"=>"D000005151", "term"=>"Facial Injuries"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000003316", "term"=>"Corneal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M28724", "name"=>"Corneal Perforation", "asFound"=>"Corneal Perforation", "relevance"=>"HIGH"}, {"id"=>"M30499", "name"=>"Corneal Injuries", "relevance"=>"LOW"}, {"id"=>"M8274", "name"=>"Eye Injuries", "relevance"=>"LOW"}, {"id"=>"M21089", "name"=>"Facies", "relevance"=>"LOW"}, {"id"=>"M8294", "name"=>"Facial Injuries", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}, {"id"=>"M6539", "name"=>"Corneal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2020-10-23", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"A Novel Sandwich Technique for Corneal Perforation", "timeFrame"=>"one year", "description"=>"By sandwiching the corneal lenticules interlamellar implantation, STMIK as an alternative novel treatment and effective procedure that provides an option to restore the corneal integrity and improve vision in patients with corneal perforations."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Corneal perforation, Corneal stromal lenticule,Sandwich technique"], "conditions"=>["Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.\n\nThe main question\\[s\\] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.\n\n2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.\n\nParticipants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "genderBased"=>true, "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients premedicated for keratoplasty surgery", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patients with corneal perforation who are willing to undergo treatment with this new technique;\n2. The size of cornea perforation was ≦ 3mm\n\nExclusion Criteria:\n\n1. The size of cornea perforation was \\>3mm\n2. Patients with corneal perforation who were unwilling to be treated with this new technique.\n3. Patients who could not be followed up regularly."}, "identificationModule"=>{"nctId"=>"NCT06233409", "acronym"=>"STMIK", "briefTitle"=>"A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation", "organization"=>{"class"=>"OTHER", "fullName"=>"Tianjin Eye Hospital"}, "officialTitle"=>"A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation", "orgStudyIdInfo"=>{"id"=>"zhangyi2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"lenticules group", "description"=>"Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography"}, {"label"=>"Penetrating keratoplasty group", "description"=>"Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Tianjin", "state"=>"Tianjin", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"yan wang, director", "role"=>"CONTACT", "email"=>"wangyan7143@vip.sina.com", "phone"=>"+862227313336"}], "facility"=>"Tianjin Eye Hospital", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}], "centralContacts"=>[{"name"=>"Luxia Chen，PHD,MD, Doctorate", "role"=>"CONTACT", "email"=>"Chen2006317@126.com", "phone"=>"Telephone: 022-27313336", "phoneExt"=>"+8618202287817"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tianjin Eye Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
