[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506144":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":161,"collaborators":165,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":18,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":18,"enrollmentInfo":183,"targetDuration":18,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"University of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Corneal Crosslinking (CXL)","EXPERIMENTAL","In the intervention group, the study intervention (CXL) will be administered to stabilize therecipient cornea (which remains in place after penetrating keratoplasty) and to reduce CoNV 8 to 10 weeks prior to corneal transplantation. The study intervention will be repeated once (after 4 weeks prior to transplantation at the latest at the earliest) if insufficient (less than 50%) reduction of CoNV should be observed (to be decided by the respective surgeon). (Protocol V04\\_0 Page 45) Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). (Protocol V04\\_0 Page 46)",[13],"Device: Corneal Crosslinking",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","NO_INTERVENTION","In the control group subjects will be directly scheduled for corneal transplantation without previous CXL. A sham CXL procedure will not be performed. Corneal transplantation will be performed as standard full-thickness penetrating procedure, and the graft (6.5 to 8.25 in diameter) will be secured with 16-24 interrupted single or 2 double running 10-0 nylon sutures (decision by the surgeon). In case of residual CoNV in the intervention group, visible vessels will may be thermally occluded by fine needle diathermy to avoid intraoperative bleeding and reduce complications (to be decided by the respective surgeon at start of surgery). In the control group, no fine needle diathermy will be performed, as this procedure combined with corneal transplantation in previously non-crosslinked eyes might lead to fistulas and thereby to potential intraocular infections. (Protocol V04\\_0 Page 46)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Corneal Crosslinking","Riboflavin isotonic, 0,1 % Vitamin B2, with Dextran 20,0%, for epi-off procedure or Riboflavin isotonic 0,1% (Vitamin B2), 1,1% HPMC without Dextran for epi-off) 0.1% riboflavin-5-phosphate and 20% dextran T-500) will be applied to the cornea after epithelial debridement every 2 min for 10 minutes before irradiation and every 2 minutes during the course of a 10 minute exposure to 365 nm UV-A with an irradiance rate of 9 mW\u002Fcm2. This dose, mode and scheme of the intervention follows the internationally recognized \"accelerated CXL protocol\" (Elbaz et al. 2014). The data existing shows equivalent outcome regarding efficacy and safety compared to the standard protocol. To avoid any damage to the limbal stem cells, the limbus will not be irradiated during the procedure, as a CXL device (with maximal diameter of 11 mm) will be used. Furthermore, the limbal area will additionally be protected by a custom-cut LSC protection shield. (Protocol V04\\_0 Page 45-46)",[9],[26],{"name":27,"affiliation":28,"role":29},"Claus Cursiefen, Prof. Dr.","University Hospital of Cologne, Centre for Ophthalmology","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","00492214784300","marie.seifert@uk-koeln.de",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Deniz Hos, Dr.","004922147898896","deniz.hos@uk-koeln.de",[40,59,74,91,109,127,144],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Augenklinik des Klinikums der Universität München","RECRUITING","München","Bavaria","80336","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],13.46314,48.69668,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":57,"phoneExt":18,"email":58},"Nikolaus Luft, PD Dr. med. univ. Dr. scient.","0089 4400 53146","nikolaus.luft@med.uni-muenchen.de",{"facility":28,"status":42,"city":60,"state":61,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Cologne","North Rhine-Westphalia","50937",{"type":49,"coordinates":64},[65,66],6.95,50.93333,{"lat":66,"lon":65},[69,72],{"name":70,"role":32,"phone":71,"phoneExt":18,"email":34},"Claus Cursiefen, Professor","00492214780",{"name":73,"role":32,"phone":37,"phoneExt":18,"email":38},"Deniz Hos, PD Dr. med",{"facility":75,"status":42,"city":76,"state":61,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde","Düsseldorf","40225",{"type":49,"coordinates":79},[80,81],6.77927,51.22319,{"lat":81,"lon":80},[84,88],{"name":85,"role":32,"phone":86,"phoneExt":18,"email":87},"Gerd Geerling, Univ.-Prof. Dr. med","004902118116051","geerling@med.uni-duesseldorf.de",{"name":89,"role":32,"phone":86,"phoneExt":18,"email":90},"Friedrich Anton Steindor, Dr. med","FriedrichAnton.Steindor@med.uni-duesseldorf.de",{"facility":92,"status":42,"city":93,"state":94,"zip":95,"country":46,"countryCode":47,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde","Homburg","Saarland","66424",{"type":49,"coordinates":97},[98,99],7.33867,49.32637,{"lat":99,"lon":98},[102,106],{"name":103,"role":32,"phone":104,"phoneExt":18,"email":105},"Berthold Seitz, Prof. Dr.","0049 6841 16-22387","berthold.seitz@uks.eu",{"name":107,"role":32,"phone":104,"phoneExt":18,"email":108},"Elias Flockerzi, Dr. med.","elias.flockerzi@uks.eu",{"facility":110,"status":42,"city":111,"state":18,"zip":112,"country":46,"countryCode":47,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde","Berlin","13353",{"type":49,"coordinates":114},[115,116],13.41053,52.52437,{"lat":116,"lon":115},[119,123],{"name":120,"role":32,"phone":121,"phoneExt":18,"email":122},"Tina Dietrich-Ntoukas, PD Dr. med.","004930450654419","tina.dietrich-ntoukas@charite.de",{"name":124,"role":32,"phone":125,"phoneExt":18,"email":126},"Anna-Karina Maier-Wenzel, PD Dr. med.","0049 30 450 654 419","anna-karina.maier@charite.de",{"facility":128,"status":42,"city":129,"state":18,"zip":130,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Universitätsklinikum Freiburg, Klinik für Augenheilkunde","Freiburg im Breisgau","79106",{"type":49,"coordinates":132},[133,134],7.85222,47.9959,{"lat":134,"lon":133},[137,141],{"name":138,"role":32,"phone":139,"phoneExt":18,"email":140},"Daniel Böhringer, Prof. Dr. med.","0049761 270-40235","Daniel.Boehringer@uniklinik-freiburg.de",{"name":142,"role":32,"phone":139,"phoneExt":18,"email":143},"Paola Kammrath Betancor, Dr. med.","paola.kammrath.betancor@uniklinik-freiburg.de",{"facility":145,"status":42,"city":146,"state":18,"zip":147,"country":46,"countryCode":47,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock","Rostock","18057",{"type":49,"coordinates":149},[150,151],12.14049,54.0887,{"lat":151,"lon":150},[154,158],{"name":155,"role":32,"phone":156,"phoneExt":18,"email":157},"Marcus Walckling, Dr. med.","0049381 494 8501","marcus.walckling@med.uni-rosto",{"name":159,"role":32,"phone":156,"phoneExt":18,"email":160},"Thomas A. Fuchsluger, Univ.-Prof. Dr. med. Dr. rer.","sekretariat.uak@med.uni-rostock.de",{"type":162,"investigatorFullName":163,"investigatorTitle":164,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Claus Cursiefen","Prof. Dr.",[166,169,171],{"name":167,"class":168},"Uniklinik Köln, Zentrum für Klinische Studien","UNKNOWN",{"name":170,"class":168},"Uniklinik Köln, Institut für Medizinische Statistik und Bioinformatik",{"name":172,"class":173},"German Federal Ministry of Education and Research","OTHER_GOV","100506144","pretreatment-to-promote-graft-survival-after-subsequent-high-risk-corneal-transplantation-crosscornealvision-100506144",false,"NCT05870566","Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]","UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]","Inclusion Criteria:\n\nMedical condition or disease to be investigated:\n\n\\- Pathologically prevascularized cornea with need for corneal transplantation\n\nFurther inclusion criteria:\n\n* Written informed consent by subject and\u002For witness prior to any study-related procedures\n* Adult male and female subjects ≥ 18 years old\n* ≥ 2 corneal quadrants covered by pathological corneal neovascularization\n* Absence of other clinical contraindications to any part or product of the treatment plan\n* A cooperative attitude to follow up the study procedures\n* In case of bilateral disease only one eye will be included\n* Steroid responders with adequate control regiment or local\u002Fsystemic therapy can be included\n\nExclusion Criteria:\n\n* \\\u003C 2 corneal quadrants covered by pathological neovascularization\n* Corneal stromal thickness below 400 μm (except in the central 8 mm zone which will be replaced later by a new corneal transplant with new endothelium); peripheral stromal thinning below 400 μm in weakened recipient areas is acceptable for CXL if not affecting more than 50% of the corneal circumference (allowing for later endothelial repopulation)\n* Active or suspected intraocular inflammation\n* Active corneal ulceration\n* Compromised eyelid mobility and\u002For symblepharon\n* Allergy, sensitivity or intolerance to riboflavin or UV\n* Contraindications, other than steroid response to the local or systemic antibiotics and\u002For corticosteroids (other than steroid response) foreseen by the protocol\n* Contraindications to the surgical protocol\n* Clinically significant or unstable concurrent disease or other medical condition affecting grafting procedure\n* Rheumatic diseases treated with systemic immunosuppressive medication\n* Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments\n* Participation in another clinical trial where an investigational drug was received less than 4 weeks prior to screening visit\n* Positive for human immunodeficiency virus (HIV)\n* Known abuse of alcohol, drugs, or medicinal products\n* Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the subject's compliance, or place the subject at high risk of complications related to the treatment\n* Employees of the sponsor, or employees or relatives of the investigator.\n* Pregnant women and nursing mothers as corneal transplantation in standard care is performed under general anaesthesia\n* Persons held in an institution by legal or official order\n* Dysregulated glaucoma with IOP \\> 25 mmHg at baseline despite local therapy\n\n(Protocol V04\\_0 Page 43)","ALL","18 Years",{"count":184,"type":185},110,"ESTIMATED","INTERVENTIONAL",[188],"NA","The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation. The goal is to improve graft survival by reducing pathological vessels through pre-treatment.",[191],"Corneal Transplantation",[193,194,195,196],"Cornea","Transplantation","Prevascularized Corneas","Corneal crosslinking with UV light irradiation","2024-10-17",{"date":199,"type":200},"2024-10-21","ACTUAL",{"date":202,"type":200},"2023-11-20",{"date":204,"type":185},"2028-09-30",{"name":163,"class":6},7]