Nctid:
NCT06616506
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002386", "term"=>"Cataract"}, {"id"=>"D009216", "term"=>"Myopia"}], "ancestors"=>[{"id"=>"D007905", "term"=>"Lens Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}, {"id"=>"D012030", "term"=>"Refractive Errors"}], "browseLeaves"=>[{"id"=>"M5638", "name"=>"Cataract", "asFound"=>"Cataract", "relevance"=>"HIGH"}, {"id"=>"M12168", "name"=>"Myopia", "asFound"=>"Myopia", "relevance"=>"HIGH"}, {"id"=>"M10917", "name"=>"Lens Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}, {"id"=>"M14872", "name"=>"Refractive Errors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>500000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2016-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2035-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-27", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2030-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract", "timeFrame"=>"10 YEARS"}, {"measure"=>"a multi-center artificial intelligence model for the cataract grading and its clinical application in highly myopic cataract", "timeFrame"=>"8 years"}], "secondaryOutcomes"=>[{"measure"=>"a multi-center artificial intelligence model for the risk prediction of perioperative complications and its clinical application in highly myopic cataract", "timeFrame"=>"10 years"}, {"measure"=>"a multi-center artificial intelligence model for the surgical outcome prediction and its clinical application in highly myopic cataract", "timeFrame"=>"10 years"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["highly myopic cataract", "artificial intelligence", "cataract", "big data"], "conditions"=>["Cataract", "High Myopia", "Myopia", "Automatic Judgement", "Risk Reduction", "Diagnoses Disease"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.", "detailedDescription"=>"High myopia cataract (HMC) is a complex cataract with high risk of blindness. At present, there are nearly 300 million people with high myopia in the world, which will increase to 500 million by 2020. Asia is the high incidence of myopia in the world. At present, there are more than 500 million people with myopia in China alone, of which nearly 100 million are high myopia, and this number is still growing rapidly. Correspondingly, the incidence rate of cataract with high myopia has also increased rapidly, which accounts for over 40% of cataract surgery.\n\nIn the early stage of the project team's analysis of refractive error after high myopia cataract surgery, it was found that the accuracy of intraocular lens calculation formula, which is widely recommended for high myopia cataract at present, is still worrying, because most of these formulas are based on the European and American eye data, while the European and American databases have few ultra high myopia data, which greatly affects the formula's accuracy In addition, the calculation of the existing formula needs to include multiple biometric indicators, and can be obtained based on complex algorithms. Artificial intelligence technology is exactly an effective means to solve this kind of problem. Therefore, based on the data of Asian population with high myopia and high incidence, the establishment of an intelligent model for the accurate calculation of high myopia cataract IOL will greatly improve the measurement accuracy Sex.\n\nTherefore, the purpose of this study is to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Prospective Cohort Study", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nAxial length ≥ 26 mm and patients with high myopia complicated by cataracts who visit our hospital.\n\nPreoperative anterior segment photography and cataract severity assessment, along with fundus OCT examination, have been performed.\n\nIf surgical treatment is conducted, the postoperative follow-up period should be no less than 1 month.\n\nThere are no missing clinical data before and after the surgery.\n\nExclusion Criteria:\n\nPatients who are unable to cooperate with the required examinations for this study."}, "identificationModule"=>{"nctId"=>"NCT06616506", "acronym"=>"AI-HMC", "briefTitle"=>"Artificial Intelligence for Highly Myopic Cataract", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai High Myopia Study Group"}, "officialTitle"=>"Artificial Intelligence for Highly Myopic Cataract", "orgStudyIdInfo"=>{"id"=>"NSFC-81970780"}, "secondaryIdInfos"=>[{"id"=>"SYA202006", "type"=>"OTHER_GRANT", "domain"=>"Eye and Ear, Nose and Throat Hospital, Fudan University"}, {"id"=>"SHDC12019X08", "type"=>"OTHER_GRANT", "domain"=>"Shanghai Shenkang Hospital Development Center"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Highly myopic cataract patients without fundus defects", "description"=>"Highly myopic cataract patients with fundus defects", "interventionNames"=>["Device: newly-invented AI model"]}, {"label"=>"Highly myopic cataract patients with fundus defects", "interventionNames"=>["Device: newly-invented AI model"]}, {"label"=>"Highly myopic cataract patients with lens grading of NC2-3", "interventionNames"=>["Device: newly-invented AI model"]}, {"label"=>"Highly myopic cataract patients with lens grading of NC4-5", "interventionNames"=>["Device: newly-invented AI model"]}], "interventions"=>[{"name"=>"newly-invented AI model", "type"=>"DEVICE", "description"=>"Apply newly-invented AI models to assist in determining surgical plans and outcome prediction.", "armGroupLabels"=>["Highly myopic cataract patients with fundus defects", "Highly myopic cataract patients with lens grading of NC2-3", "Highly myopic cataract patients with lens grading of NC4-5", "Highly myopic cataract patients without fundus defects"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200031", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"XIANGJIA ZHU, M.D.", "role"=>"CONTACT", "email"=>"zhuxiangjia1982@126.com", "phone"=>"(86)021-64377134"}], "facility"=>"Eye and ENT Hospital of Fudan University", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"WENWEN HE", "role"=>"CONTACT", "email"=>"alicewen@139.com", "phone"=>"+86-15021154594"}, {"name"=>"KEKE ZHANG", "role"=>"CONTACT", "email"=>"shirley18158@163.com"}], "overallOfficials"=>[{"name"=>"XIANGJIA ZHU", "role"=>"STUDY_CHAIR", "affiliation"=>"Eye & ENT Hospital of Fudan University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai High Myopia Study Group", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Eye and ENT Hospital of Fudan University", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
