[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472805":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":44,"locations":54,"responsibleParty":222,"collaborators":224,"id":228,"slug":229,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":230,"sex":236,"minAge":237,"maxAge":72,"enrollmentInfo":238,"targetDuration":72,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":251,"overallStatus":57,"whyStopped":72,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK)","ACTIVE_COMPARATOR","Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) refers to the use of a corneal endothelial\u002FDescemet graft with a thin layer of stroma (\\\u003C110um) attached.\n\nThe cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.\n\nIn the DSAEK technique, a piece of the donor's endothelium is transplanted with a supporting layer of donor stroma.",[13],"Procedure: UT-DSAEK",{"label":15,"type":10,"description":16,"interventionNames":17},"Descemet membrane endothelial keratoplasty (DMEK)","Descemet membrane endothelial keratoplasty refers to the use of a corneal endothelial\u002FDescemet graft with no layer of associated stroma (15-20um thick).\n\nThe cornea is made up of 5 layers, all of which work to provide a clear image on the retina. The innermost layer of cells, the endothelium, is responsible for pumping fluid out of the cornea and keeping it transparent: a normal endothelium is essential to keeping the cornea clear. The endothelium lies on a membrane called the Descemet membrane. The thickest layer of the cornea is called the stroma and this provides rigidity and strength to the cornea. When the corneal endothelium fails, it cannot regrow and the best treatment is to replace the cells with healthy donor cells. This is called a corneal endothelial transplantation or endothelial keratoplasty.\n\nIn the DMEK technique only a piece of donor endothelium layer is together with its supporting membrane (the Descemet membrane), is transplanted.",[18],"Procedure: DMEK",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","UT-DSAEK","The main incision (3.5-5mm) is created at the corneal limbus or via a cornea-scleral tunnel with 2-3 smaller (approx. 1mm) paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber, according to the surgeon's preference. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed. Once the anterior chamber is prepared, OVD or air has been removed, then the eye is ready for the new corneal graft.\n\nThe pre-cut corneal tissue delivered by the bank is then gently rinsed and may be stained with 0.06% trypan blue if required. The tissue is loaded into a glide or injector, and pulled into the anterior chamber using a smooth-tipped micro-forceps (e.g., Busin forceps). Once the graft enters the eye, it is lifted to the posterior cornea. The graft is further centred using air (or SF6 Gas) in the anterior chamber.",[9],[26],"Ultra-Thin Descemet Stripping Automated Endothelial Keratoplasty",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DMEK","The main incision (2.8-3mm) is created superior or temporally at the corneal limbus and is accompanied by 2-3 smaller paracentesis incisions. An ophthalmic viscosurgical device (OVD) or a continuous infusion of water or air can be used to maintain the stability of the anterior chamber. The corneal endothelium is scored using a scoring instrument and the central diseased corneal endothelium is removed.\n\nThe DMEK roll is poured into a basin and rinsed. The graft is then stained with 0.06% trypan blue to aid in graft visualization. The graft is loaded into an injector and introduced into the anterior chamber. The graft is unrolled using external manoeuvres and once unrolled, it is lifted to the back of the cornea. The eye is then pressurised with a full air fill from 10 to 120 minutes. The pressure is then reduced and the case is completed by suturing any incisions required.",[15],[32],"Descemet Membrane Endothelial Keratoplasty",[34,38,41],{"name":35,"affiliation":36,"role":37},"Sorcha Ni Dhubhghaill, MBBCh, PhD","Universitair Ziekenhuis Brussel","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":40},"Carina Koppen, MD, PhD","STUDY_CHAIR",{"name":42,"affiliation":43,"role":40},"Bernard Duchesne, MD, PhD","University Hospital Liege",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Veerle Van Gerwen, BSc","CONTACT","+3238210000","5271","bestcornea@uza.be",{"name":52,"role":47,"phone":48,"phoneExt":53,"email":50},"Axelle Belis, BSc","2466",[55,77,91,106,120,137,149,163,177,188,204],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":64,"coordinates":65},"Point",[66,67],4.44504,51.15662,{"lat":67,"lon":66},[70,74],{"name":71,"role":47,"phone":72,"phoneExt":72,"email":73},"veerle Van Gerwen, BSc",null,"veerle.vangerwen@uza.be",{"name":75,"role":76,"phone":72,"phoneExt":72,"email":72},"Carina Koppen, PhD","PRINCIPAL_INVESTIGATOR",{"facility":78,"status":57,"city":79,"state":80,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"AZ Maria Middelares","Ghent","Oost-Vlaanderen",{"type":64,"coordinates":82},[83,84],3.71667,51.05,{"lat":84,"lon":83},[87,90],{"name":88,"role":47,"phone":72,"phoneExt":72,"email":89},"Ilse Claerhout, PhD","Ilse.Claerhout@azmmsj.be",{"name":88,"role":76,"phone":72,"phoneExt":72,"email":72},{"facility":92,"status":57,"city":93,"state":94,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"AZ Sint-Jan Brugge","Bruges","West-Vlaanderen",{"type":64,"coordinates":96},[97,98],3.22424,51.20892,{"lat":98,"lon":97},[101,104],{"name":102,"role":47,"phone":72,"phoneExt":72,"email":103},"Liesbeth Laloo","Liesbeth.Laloo@azsintjan.be",{"name":105,"role":76,"phone":72,"phoneExt":72,"email":72},"Sylvie Vandelanotte, MD",{"facility":107,"status":57,"city":108,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"AZ Imelda","Bonheiden",{"type":64,"coordinates":110},[111,112],4.54714,51.02261,{"lat":112,"lon":111},[115,118],{"name":116,"role":47,"phone":72,"phoneExt":72,"email":117},"Leslie Deroy","leslie.deroy@imelda.be",{"name":119,"role":76,"phone":72,"phoneExt":72,"email":72},"Karolien Termote, MD",{"facility":121,"status":57,"city":122,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Erasmus ziekenhuis Brussel","Brussels",{"type":64,"coordinates":124},[125,126],4.34878,50.85045,{"lat":126,"lon":125},[129,132,134],{"name":130,"role":47,"phone":72,"phoneExt":72,"email":131},"Pauline Le Roux","pauline.leroux@hubruxelles.be",{"name":133,"role":76,"phone":72,"phoneExt":72,"email":72},"Marc Schrooyen, PhD",{"name":135,"role":136,"phone":72,"phoneExt":72,"email":72},"Pauline Le Roux, MD","SUB_INVESTIGATOR",{"facility":138,"status":57,"city":122,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"UZ Brussel",{"type":64,"coordinates":140},[125,126],{"lat":126,"lon":125},[143,146,147],{"name":144,"role":47,"phone":72,"phoneExt":72,"email":145},"Bert Verhelst","bert.verhelst@uzbrussel.be",{"name":119,"role":76,"phone":72,"phoneExt":72,"email":72},{"name":148,"role":136,"phone":72,"phoneExt":72,"email":72},"Sorcha Ni Dhubhghaill, PhD",{"facility":150,"status":57,"city":151,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"AZ Monica (campus Deurne)","Deurne",{"type":64,"coordinates":153},[154,155],4.46595,51.22134,{"lat":155,"lon":154},[158,161],{"name":159,"role":47,"phone":72,"phoneExt":72,"email":160},"Caroline Lamoen","caroline.lamoen@azmonica.be",{"name":162,"role":76,"phone":72,"phoneExt":72,"email":72},"Isabel Bleyen, MD",{"facility":164,"status":57,"city":165,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Ziekenhuis Oost-Limburg (ZOL)","Genk",{"type":64,"coordinates":167},[168,169],5.50082,50.965,{"lat":169,"lon":168},[172,175],{"name":173,"role":47,"phone":72,"phoneExt":72,"email":174},"Frauke Somers","frauke.somers@zol.be",{"name":176,"role":76,"phone":72,"phoneExt":72,"email":72},"Sacha Gast, MD",{"facility":178,"status":57,"city":79,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":179,"geoPoint":181,"contacts":182},"UZ Gent",{"type":64,"coordinates":180},[83,84],{"lat":84,"lon":83},[183,186],{"name":184,"role":47,"phone":72,"phoneExt":72,"email":185},"Julie Sambaer","octu@uzgent.be",{"name":187,"role":76,"phone":72,"phoneExt":72,"email":72},"Dimitri Roels, MD",{"facility":189,"status":57,"city":190,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"UZ Leuven","Leuven",{"type":64,"coordinates":192},[193,194],4.70093,50.87959,{"lat":194,"lon":193},[197,200,202],{"name":198,"role":47,"phone":72,"phoneExt":72,"email":199},"Martine Spaas","martine.spaas@uzleuven.be",{"name":201,"role":136,"phone":72,"phoneExt":72,"email":72},"Isabelle Saelens, PhD",{"name":203,"role":76,"phone":72,"phoneExt":72,"email":72},"Heleen Delbeke, MD",{"facility":205,"status":57,"city":206,"state":72,"zip":72,"country":61,"countryCode":62,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"CHU Liège","Liège",{"type":64,"coordinates":208},[209,210],5.56749,50.63373,{"lat":210,"lon":209},[213,216,218,220],{"name":214,"role":47,"phone":72,"phoneExt":72,"email":215},"Séverine Camby","s.camby@chuliege.be",{"name":217,"role":76,"phone":72,"phoneExt":72,"email":72},"Bernard Duchense, PhD",{"name":219,"role":136,"phone":72,"phoneExt":72,"email":72},"Céline La, MD",{"name":221,"role":136,"phone":72,"phoneExt":72,"email":72},"Sandrine Hick, MD",{"type":223,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR",[225],{"name":226,"class":227},"Belgium Health Care Knowledge Centre","OTHER_GOV","100472805","the-belgian-endothelial-surgical-transplant-of-the-cornea-100472805",false,"NCT05436665","The Belgian Endothelial Surgical Transplant of the Cornea","The Belgian Endothelial Surgical Transplant of the Cornea:Clinical and Patient-reported Outcomes of Descemet Stripping Automated Endothelial Keratoplasty(DSAEK) Versus Descemet Membrane Endothelial Keratoplasty(DMEK)","BESTCornea","Inclusion Criteria:\n\n* Fuchs Endothelial Dystrophy (FED);\n* Bullous Keratopathy (BK);\n* Other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft;\n* Pseudophakic (post cataract surgery);\n* Patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires;\n* Patients willing and capable to attend the 3, 6, and 12-month follow-up appointments.\n\nExclusion Criteria:\n\n* Inability to provide informed consent;\n* Patients unable to attend the proposed follow up;\n* Inclusion of the fellow eye in the study;\n* Complex surgery combined with multiple pathologies (i.e., glaucoma surgery);\n* Other contraindications to lamellar corneas surgery;\n* Patients who elect not to participate;\n* Patients under 18 years of age;\n* Patients that are currently pregnant or breastfeeding;\n* Phakic patients with no direct plan to perform cataract surgery.","ALL","18 Years",{"count":239,"type":240},220,"ESTIMATED","INTERVENTIONAL",[243],"NA","This study is designed as a randomised multicentric parallel group pragmatic trial of Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus Descemet Membrane Endothelial Keratoplasty (DMEK) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.",[246,247,248,249,250],"Corneal Edema","Corneal Endothelial Disorder","Fuchs' Endothelial Dystrophy","Bullous Keratopathy","Pseudophakic Bullous Keratopathy",[28,252,22],"DSAEK","2026-03-30",{"date":255,"type":256},"2026-04-03","ACTUAL",{"date":258,"type":256},"2022-08-10",{"date":260,"type":240},"2028-06-06",{"name":5,"class":6},11]