[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591621":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 4.0-VISULYZE group","EXPERIMENTAL","The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE",[13],"Procedure: Group 4.0-VISULYZE",{"label":15,"type":16,"description":17,"interventionNames":18},"traditional group","ACTIVE_COMPARATOR","The traditional group had their infusion rates based on past experience.",[19],"Procedure: traditional group",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Group 4.0-VISULYZE",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Ying Yu, professor","CONTACT","86 15996621616","yuying.2009@163.com",[35,49],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"The Affiliated Hospital of Nantong University","ACTIVE_NOT_RECRUITING","Nantong","Jiangsu","226001","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.87472,32.03028,{"lat":47,"lon":46},{"facility":36,"status":50,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"RECRUITING",{"type":44,"coordinates":52},[46,47],{"lat":47,"lon":46},[55],{"name":56,"role":31,"phone":57,"phoneExt":25,"email":58},"Wei Shi","86 62806546","tdfykjc@163.com",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100591621","clinical-study-of-smile-40-visulyze-in-correcting-refractive-errors-100591621",false,"NCT06982807","Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors","Inclusion Criteria:\n\n1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);\n2. Age: 18 to 40 years old;\n3. Optimal preoperative corrected visual acuity ≥4.8;\n4. More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery\n5. Patients who are willing to perform SMILE surgery\n\nExclusion Criteria:\n\n1. Patients with history of eye surgery and trauma;\n2. Patients with keratoconus tendency;\n3. systemic connective tissue diseases and autoimmune diseases;\n4. Patients with high blood pressure, diabetes and heart disease history;\n5. Other eye disease history such as uveitis, scleritis and other eye inflammation patients;\n6. Patients with scar constitution.","ALL","18 Years","40 Years",{"count":71,"type":72},600,"ESTIMATED","INTERVENTIONAL",[75],"NA","The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.\n\nIn this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.\n\nThe investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.",[78,79],"Refractive Surgery","Myopia; Refractive Error","2025-05-22",{"date":82,"type":83},"2025-05-28","ACTUAL",{"date":85,"type":83},"2024-11-01",{"date":87,"type":72},"2026-12-31",{"name":5,"class":6},2]