[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620586":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":11,"armGroups":39,"interventions":52,"overallOfficials":11,"centralContacts":62,"locations":72,"responsibleParty":127,"collaborators":129,"id":135,"slug":11,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":11,"enrollmentInfo":144,"targetDuration":11,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Intraocular pressure",null,"1 year",[14,18,21,23,25,27,29],{"measure":15,"description":16,"timeFrame":17},"Number of medications","Number of topical glaucoma medications","2 year",{"measure":19,"description":11,"timeFrame":20},"adverse events","2 years",{"measure":22,"description":11,"timeFrame":20},"secundary pressure-lowering surgery",{"measure":24,"description":11,"timeFrame":20},"Mean Deviation changes on the visual field",{"measure":26,"description":11,"timeFrame":20},"Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography",{"measure":28,"description":11,"timeFrame":20},"Endothelial Cell Count",{"measure":30,"description":11,"timeFrame":20},"Best Corrected Visual Acuity",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"PRESERFLO MicroShunt","EXPERIMENTAL","The PFMS is a SIBS-polymer microshunt.",[45],"Device: PRESERFLO™ MicroShunt",{"label":47,"type":48,"description":49,"interventionNames":50},"XEN 63 Gelstent","ACTIVE_COMPARATOR","The XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin).",[51],"Device: XEN®-63 Gel Stent",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"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.",[47],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"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.",[41],[63,68],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Ingeborg Stalmans, MD, PhD","CONTACT","+3216340391","oogziekten.glaucoomstudies@uzleuven.be",{"name":69,"role":65,"phone":70,"phoneExt":11,"email":71},"Thomas Jacobs, MD","+16346108","thomas.jacobs@uzleuven.be",[73,92,109],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"University Hospitals UZ Leuven","RECRUITING","Leuven","Vlaams-brabant","3000","Belgium","BE",{"type":82,"coordinates":83},"Point",[84,85],4.70093,50.87959,{"lat":85,"lon":84},[88,90],{"name":89,"role":65,"phone":66,"phoneExt":11,"email":67},"Ingeborg Stalmans, Prof. Dr.",{"name":69,"role":65,"phone":91,"phoneExt":11,"email":71},"+3216346108",{"facility":93,"status":75,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Universitätsklinikum Bonn","Bonn","North Rhine-Westphalia","D-53127","Germany","DE",{"type":82,"coordinates":100},[101,102],7.09549,50.73438,{"lat":102,"lon":101},[105],{"name":106,"role":65,"phone":107,"phoneExt":11,"email":108},"Karl Mercieca, Prof. Dr.","+44 7894 230224","Karl.Mercieca@ukbonn.de",{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"ULS Santa Maria","NOT_YET_RECRUITING","Lisbon","Lisbon District","1649-028","Portugal","PT",{"type":82,"coordinates":118},[119,120],-9.1498,38.72509,{"lat":120,"lon":119},[123],{"name":124,"role":65,"phone":125,"phoneExt":11,"email":126},"Luis Pinto, Prof. Dr.","+351 965 132 279","abegaopinto@gmail.com",{"type":128,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[130,132],{"name":131,"class":6},"University Hospital, Bonn",{"name":133,"class":134},"Hospital de Santa Maria, Lisbon","UNKNOWN","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":145,"type":146},166,"ESTIMATED","INTERVENTIONAL",[149],"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.",[152],"GLAUCOMA 1, OPEN ANGLE, D (Disorder)",[154,155,156,157,158,159,160,161,162],"Glaucoma","MIBS","Minimally Invasive Bleb-Forming Surgery","Bleb-Forming Devices Without a Plate","Surgery","PRESERFLO","MicroShunt","XEN","Gelstent","2026-04-28",{"date":165,"type":166},"2026-04-29","ACTUAL",{"date":168,"type":166},"2026-01-01",{"date":170,"type":146},"2028-01",{"name":5,"class":6},3]