[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603534":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":71,"collaborators":73,"id":79,"slug":20,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":20,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":20,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":101,"whyStopped":20,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"TECLens, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Epithelium-on Corneal Crosslinking",[13],"Device: Quantitative refractive crosslinking",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Quantitative refractive crosslinking","Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Patrick Lopath","CONTACT","919-824-5224","plopath@teclens.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Ibrahim Seven","440-485-9091","ibrahim.seven@teclens.com",[32,53],{"facility":33,"status":20,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Rio Vision Hospital Oftalmológico","Rio de Janeiro","Brazil","BR",{"type":38,"coordinates":39},"Point",[40,41],-43.18223,-22.90642,{"lat":41,"lon":40},[44,48,50],{"name":45,"role":24,"phone":46,"phoneExt":20,"email":47},"Monica Pinto","55-21-9856-81649","Monicacrispinto15@gmail.com",{"name":49,"role":24,"phone":20,"phoneExt":20,"email":20},"Erica Rossi, 55-21-98391-1111",{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Renato Ambrósio","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":20,"city":55,"state":20,"zip":20,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Laser Center","Santo Domingo","Dominican Republic","DO",{"type":38,"coordinates":59},[60,61],-69.89232,18.47186,{"lat":61,"lon":60},[64,69],{"name":65,"role":24,"phone":66,"phoneExt":67,"email":68},"Maria C Varela","809-593-1324","1350","oftalmed@claro.net.do",{"name":70,"role":52,"phone":20,"phoneExt":20,"email":20},"Juan Batlle, Jr.",{"type":72,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[74,77],{"name":75,"class":76},"Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil","UNKNOWN",{"name":78,"class":76},"Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.","100603534",false,"NCT07137767","Quantitative Refractive Crosslinking in Presbyopia Aged Patients","Quantitative Refractive Crosslinking in Presbyopia-Aged Patients: An Open Label, Multi-center, Phase I Study of the TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age","Inclusion Criteria:\n\n* Adults aged 40-65 years\n* Healthy cornea\n* Refractive error between +4.0 D and -5.0 D\n* Phakic or monofocal pseudophakic (≥6 months post IOL placement)\n* Visual acuity correctable by ±0.25 D\n\nExclusion Criteria:\n\n* Corneal dystrophy, scarring, or prior corneal crosslinking\n* Astigmatism \\>1.0 D\n* Active ocular infection, inflammation, or uncontrolled dry eye\n* Advanced glaucoma or diabetic retinopathy\n* History of delayed corneal healing\n* Pregnancy, breastfeeding, or planning pregnancy during study period\n* Certain medications (e.g., isotretinoin)\n* Recent participation in other investigational drug\u002Fdevice studies (within 30 days)\n* Patients with uncontrolled dry eye or surface disease","ALL","40 Years","65 Years",{"count":89,"type":90},25,"ESTIMATED","INTERVENTIONAL",[93],"NA","An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.",[96],"Presbyopia",[98,96,99,100],"Corneal crosslinking","Myopia","Hyperopia","NOT_YET_RECRUITING","2025-08-22",{"date":104,"type":105},"2025-08-29","ACTUAL",{"date":107,"type":90},"2025-08-31",{"date":109,"type":90},"2026-08",{"name":5,"class":6},2]