[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620586":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":96,"collaborators":98,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":26,"enrollmentInfo":114,"targetDuration":26,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PRESERFLO MicroShunt","EXPERIMENTAL","The PFMS is a SIBS-polymer microshunt.",[13],"Device: PRESERFLO™ MicroShunt",{"label":15,"type":16,"description":17,"interventionNames":18},"XEN 63 Gelstent","ACTIVE_COMPARATOR","The XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin).",[19],"Device: XEN®-63 Gel Stent",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","XEN®-63 Gel Stent","The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PRESERFLO™ MicroShunt","The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ingeborg Stalmans, MD, PhD","CONTACT","+3216340391","oogziekten.glaucoomstudies@uzleuven.be",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Thomas Jacobs, MD","+16346108","thomas.jacobs@uzleuven.be",[42,61,78],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Hospitals UZ Leuven","RECRUITING","Leuven","Vlaams-brabant","3000","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.70093,50.87959,{"lat":54,"lon":53},[57,59],{"name":58,"role":34,"phone":35,"phoneExt":26,"email":36},"Ingeborg Stalmans, Prof. Dr.",{"name":38,"role":34,"phone":60,"phoneExt":26,"email":40},"+3216346108",{"facility":62,"status":44,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Universitätsklinikum Bonn","Bonn","North Rhine-Westphalia","D-53127","Germany","DE",{"type":51,"coordinates":69},[70,71],7.09549,50.73438,{"lat":71,"lon":70},[74],{"name":75,"role":34,"phone":76,"phoneExt":26,"email":77},"Karl Mercieca, Prof. Dr.","+44 7894 230224","Karl.Mercieca@ukbonn.de",{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"ULS Santa Maria","NOT_YET_RECRUITING","Lisbon","Lisbon District","1649-028","Portugal","PT",{"type":51,"coordinates":87},[88,89],-9.1498,38.72509,{"lat":89,"lon":88},[92],{"name":93,"role":34,"phone":94,"phoneExt":26,"email":95},"Luis Pinto, Prof. Dr.","+351 965 132 279","abegaopinto@gmail.com",{"type":97,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[99,101],{"name":100,"class":6},"University Hospital, Bonn",{"name":102,"class":103},"Hospital de Santa Maria, Lisbon","UNKNOWN","100620586","comparing-xen-63-gel-stent-and-preserflo-microshunt-100620586",false,"NCT07359547","Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt","Minimally Invasive Bleb-Forming Surgical Approaches for Treating Primary Open-Angle Glaucoma: A Randomized Controlled Trial Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt","MINI-BATTLE","Inclusion Criteria:\n\n* \\>40 years of age\n* An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX)\n* Inadequately controlled on maximum tolerated medical therapy.\n* Mean Deviation (MD) \\\u003C\u002F= -3\n* Intraocular pressure of 14-28 mmHg\n* Endothelial Cell Count ≥1000 cells\u002Fmm2\n\nExclusion Criteria:\n\n* An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)\n* Lens status: Aphakic patients or Anterior chamber intraocular lens\n* Previous procedures: Glaucoma shunt\u002Fvalve\u002F surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months.\n* Presence of intraocular silicone oil\n* No light perception vision\n* Current corticosteroid use (ocular or oral)\n* Conjunctival pathologies (e.g., pterygium)\n* Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)\n* Vitreous present in the anterior chamber\n* Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date\n* Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits","ALL","40 Years",{"count":115,"type":116},166,"ESTIMATED","INTERVENTIONAL",[119],"NA","The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery. \n\nThe main questions it aims to answer are:\n\n* Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent?\n* How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?\n\nParticipants will:\n\n* Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery.\n* Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments.\n* Receive standard postoperative care and report any complications or additional treatments during the study period.",[122],"GLAUCOMA 1, OPEN ANGLE, D (Disorder)",[124,125,126,127,128,129,130,131,132],"Glaucoma","MIBS","Minimally Invasive Bleb-Forming Surgery","Bleb-Forming Devices Without a Plate","Surgery","PRESERFLO","MicroShunt","XEN","Gelstent","2026-04-28",{"date":135,"type":136},"2026-04-29","ACTUAL",{"date":138,"type":136},"2026-01-01",{"date":140,"type":116},"2028-01",{"name":5,"class":6},3]