[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550795":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":39,"responsibleParty":86,"collaborators":20,"id":88,"slug":20,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":20,"enrollmentInfo":96,"targetDuration":20,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Recornea Srl","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","All participants will undergo the planned surgical intervention for the implantation of the investigational medical device and will be monitored for up to 1 year after the procedure.",[13],"Device: Nitinol net for intracorneal implant for keratoconus treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Nitinol net for intracorneal implant for keratoconus treatment","The investigational corneal implant device is designed for patients with keratoconus. It is intended to be surgically implanted into the cornea as a permanent implant and is made of nitinol. The device is intended to improve corneal stability and visual outcomes.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Edoardo Grosso, MD","Chief Medical Officer (CMO)","STUDY_DIRECTOR",{"name":27,"affiliation":28,"role":29},"José L. Güell, MD","Head of the Cornea, Cataract and Refractive Surgery Department at IMO","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Emiliano Lepore, Ing., PhD","CONTACT","+39 3209673891","el@recornea.com",{"name":37,"role":33,"phone":20,"phoneExt":20,"email":38},"Rossella Baldini, PhD","rb@recornea.com",[40,62],{"facility":41,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","NOT_YET_RECRUITING","Roma","00168","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],11.10642,44.99364,{"lat":51,"lon":50},[54,58,60],{"name":55,"role":33,"phone":56,"phoneExt":20,"email":57},"Luigi Mosca, MD","+39 3386244046","luigi.mosca@policlinicogemelli.it",{"name":59,"role":29,"phone":20,"phoneExt":20,"email":20},"Romina Fasciani, MD",{"name":55,"role":61,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Instituto de Microcirugía Ocular de Barcelona (IMO)","RECRUITING","Barcelona","Bar","08035","Spain","ES",{"type":48,"coordinates":71},[72,73],2.15899,41.38879,{"lat":73,"lon":72},[76,80,84],{"name":77,"role":33,"phone":78,"phoneExt":20,"email":79},"Sandra Suescun","0034934000700","sandra.suescun@imo.es",{"name":81,"role":33,"phone":82,"phoneExt":20,"email":83},"Tamara García, HNC","+934000700","tamara.garcia@miranza.es",{"name":85,"role":29,"phone":20,"phoneExt":20,"email":20},"José L Güell, MD",{"type":87,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100550795",false,"NCT06451718","First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus","First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus","Inclusion Criteria:\n\n* Signed and dated informed consent form.\n* Male and female ≥ 18 years old.\n* Not recommended for ICRS.\n* Recommended for keratoplasty.\n* Minimum corneal thickness ≥ 350 μm.\n* Best Distance Spectacle Corrected Visual Acuity (BDSCVA) with the ETDRS test ≥ 0.30 logMAR (\\\u003C= 0,50 decimal notation).\n* BCVA with RGP contact lens with the ETDRS test 10 letters or more than BCVA with spectacles.\n* Have stable or stabilized disease for 12 months (in case of crosslinking, it must have been done at least 12 months prior to intervention).\n* Have a KC stage 3-4 according to Investigator's judgement, with a central K readings \\> 47.2 D and RMS of coma aberration \\> 2.5 μm.\n* Have no known or suspected allergy to nickel.\n* Female subject of childbearing potential is eligible to participate if declaring she is not pregnant, or not breastfeeding and agree to use highly effective contraception (defined as method which results in a failure rate of \\\u003C1% annually) and must abstain from egg donation or storage throughout the study period.\n\nExclusion Criteria:\n\n* Inability of patient and\u002For relatives to understand the clinical investigation procedures and thus inability to give informed consent.\n* Untreated progressive KC.\n* Single functioning eye.\n* Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking.\n* Systemic collagenopathies and\u002For vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated.\n* Suspected or known intolerance or hypersensitivity to any of the treatments indicated in the CIP and\u002For to any component of the device (i.e. nickel).","ALL","18 Years",{"count":97,"type":98},12,"ESTIMATED","INTERVENTIONAL",[101],"NA","This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.",[104],"Keratoconus",[106,107,108,109,110,111,112,113,114,115],"GROSSO","Implant","Cornea","Surgery","Reshaper","keratoconus","keratoplasty","nitinol","corneal shape","remodeling","2026-01-14",{"date":118,"type":119},"2026-01-20","ACTUAL",{"date":121,"type":119},"2024-09-03",{"date":123,"type":98},"2027-02",{"name":5,"class":6},2]