[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100290306":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":117,"collaborators":26,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":26,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":26,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Wenzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"viscoelastic-free system","EXPERIMENTAL","Eyes in this group will use viscoelastic-free implantation system during the surgery",[13],"Device: viscoelastic-free implantation system",{"label":15,"type":16,"description":17,"interventionNames":18},"viscoelastic-assisted system","ACTIVE_COMPARATOR","Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery",[19],"Device: standard viscoelastic-assisted Implantation system",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","viscoelastic-free implantation system","Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"standard viscoelastic-assisted Implantation system","This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation",[15],[32],{"name":33,"affiliation":5,"role":34},"AYong Yu, MD. PhD.","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+86-0577-88068880","yaybetter@hotmail.com",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Anpeng Pan, MD.OD.","pananpeng@126.com",[44,61,74,93,105],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Guangdong General Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.25,23.11667,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":26,"phoneExt":26,"email":26},"Jin Zeng, MD.",{"facility":62,"status":46,"city":63,"state":64,"zip":65,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Hunan Provincial People's Hospital","Changsha","Hunan","410000",{"type":53,"coordinates":67},[68,69],112.97087,28.19874,{"lat":69,"lon":68},[72],{"name":73,"role":37,"phone":26,"phoneExt":26,"email":26},"Hua Wang, MD.",{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":50,"countryCode":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"The Eye Hispital of Wenzhou Medical University","RECRUITING","Wenzhou","Zhejiang","325000",{"type":53,"coordinates":81},[82,83],120.66682,27.99942,{"lat":83,"lon":82},[86,88,91],{"name":41,"role":37,"phone":87,"phoneExt":26,"email":42},"+86-577-88068809",{"name":89,"role":90,"phone":26,"phoneExt":26,"email":26},"Shuangqian Zhu, MD.","SUB_INVESTIGATOR",{"name":92,"role":90,"phone":26,"phoneExt":26,"email":26},"Kaijing Zhou, MD.PhD.",{"facility":94,"status":46,"city":95,"state":26,"zip":96,"country":50,"countryCode":51,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Peking Union Medical College Hospital","Beijing","100000",{"type":53,"coordinates":98},[99,100],116.39723,39.9075,{"lat":100,"lon":99},[103],{"name":104,"role":37,"phone":26,"phoneExt":26,"email":26},"Yan Luo, MD.",{"facility":106,"status":46,"city":107,"state":26,"zip":108,"country":50,"countryCode":51,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Shanghai Ninth People's Hospital","Shanghai","200000",{"type":53,"coordinates":110},[111,112],121.45806,31.22222,{"lat":112,"lon":111},[115],{"name":116,"role":37,"phone":26,"phoneExt":26,"email":26},"Jibo Zhou, MD.",{"type":34,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"A-Yong Yu","Director of the Cataract Clinical Center","100290306","safety-and-efficacy-study-of-a-viscoelastic-free-method-for-implantable-collamer-lens-icl-implantation-100290306",false,"NCT03059043","Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation","Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study","Inclusion Criteria:\n\n* Documented stable refraction for at least 1 year(within 0.5D)\n* Best spectacle-corrected visual acuity (BCVA) of 20\u002F40 or better\n* Clear central cornea\n* -0.5D to -18.0D of myopic refractive error\n* Normal anterior chamber depth at least 2.8 mm to endothelium\n* Endothelial cell density (ECD) more than 2000 cell\u002Fmm2\n* Pupil diameter smaller than 7.0 mm under mesopic condition\n* Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear\n\nExclusion Criteria:\n\n* Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease\n* Evidence of connective tissue disease or other systemic diseases that may confound the results of the study;\n* Narrow angle of anterior chamber\n* Pregnant, lactating, or planning to become pregnant during the course of the trial",true,"ALL","18 Years","45 Years",{"count":132,"type":133},60,"ESTIMATED","INTERVENTIONAL",[136],"NA","This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.",[139],"Myopia",[141,142],"Phakic Intraocular Lenses","viscoelastic","2024-07-22",{"date":145,"type":146},"2024-07-23","ACTUAL",{"date":148,"type":146},"2018-11-16",{"date":150,"type":133},"2026-06-22",{"name":5,"class":6},5]