[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611054":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":31,"responsibleParty":169,"collaborators":10,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":10,"eligibilityCriteria":177,"healthyVolunteers":173,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":10,"studyType":184,"phases":10,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":149,"whyStopped":10,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Santen SAS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Microshunt XI treatment group",null,"MicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and\u002For where glaucoma progression warrants surgery.",[13],"Device: Microshunt XI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Microshunt XI","The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device",[9],[21],"Intervention Model\u002FDevice: SIBS implant, OD 350 µm, lumen 71 µm, length 11 mm, triangular fins; subconjunctival\u002FTenon implantation.",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Study Director \u002F Medical Monitor Raymund Angeles","CONTACT","510-368-9861","raymund.angeles@santen.com",{"name":29,"role":25,"phone":10,"phoneExt":10,"email":30},"Santen SAS Clinical Operations","bianca.groenendijk@santen.com",[32,47,60,73,84,97,108,121,134,147,161],{"facility":33,"status":34,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"AKH Wien","NOT_YET_RECRUITING","Vienna","Austria","AT",{"type":39,"coordinates":40},"Point",[41,42],16.37208,48.20849,{"lat":42,"lon":41},[45],{"name":46,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Clemens Vass",{"facility":48,"status":34,"city":49,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Glaucoma Clinic, UZ Leuven","Leuven","Belgium","BE",{"type":39,"coordinates":53},[54,55],4.70093,50.87959,{"lat":55,"lon":54},[58],{"name":59,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Ingeborg Stalmans",{"facility":61,"status":34,"city":62,"state":10,"zip":10,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Internationale Innovative Opthalmochirurgie GbR","Düsseldorf","Germany","DE",{"type":39,"coordinates":66},[67,68],6.77927,51.22319,{"lat":68,"lon":67},[71],{"name":72,"role":25,"phone":10,"phoneExt":10,"email":10},"Dr Karsten Klabe",{"facility":74,"status":34,"city":75,"state":10,"zip":10,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Universitätsklinikum Tübingen, Department für Augenheilkunde","Tübingen",{"type":39,"coordinates":77},[78,79],9.05222,48.52266,{"lat":79,"lon":78},[82],{"name":83,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Bogomil Voykov",{"facility":85,"status":34,"city":86,"state":10,"zip":10,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Irccs Fondazione G. 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Bietti","Rome","Italy","IT",{"type":39,"coordinates":90},[91,92],12.51133,41.89193,{"lat":92,"lon":91},[95],{"name":96,"role":25,"phone":10,"phoneExt":10,"email":10},"Dr Francesco Oddone",{"facility":98,"status":34,"city":99,"state":10,"zip":10,"country":87,"countryCode":88,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Policlinico Universitario Molinette","Turin",{"type":39,"coordinates":101},[102,103],7.68682,45.07049,{"lat":103,"lon":102},[106],{"name":107,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Antonio Fea",{"facility":109,"status":34,"city":110,"state":10,"zip":10,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Universiteitskliniek voor Oogheelkunde Maastricht","Maastricht","Netherlands","NL",{"type":39,"coordinates":114},[115,116],5.68889,50.84833,{"lat":116,"lon":115},[119],{"name":120,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Henny Beckers",{"facility":122,"status":34,"city":123,"state":10,"zip":10,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"ULS Santa Maria, Lisboa","Lisbon","Portugal","PT",{"type":39,"coordinates":127},[128,129],-9.1498,38.72509,{"lat":129,"lon":128},[132],{"name":133,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Luis Abegao Pinto",{"facility":135,"status":34,"city":136,"state":10,"zip":10,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Hospital Clinico San Carlos","San Carlos","Spain","ES",{"type":39,"coordinates":140},[141,142],-6.2,36.48333,{"lat":142,"lon":141},[145],{"name":146,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Julián García-Feijóo",{"facility":148,"status":149,"city":150,"state":10,"zip":10,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Guy's and St. Thomas' NHS Foundation Trust","RECRUITING","London","United Kingdom","UK",{"type":39,"coordinates":154},[155,156],-0.12574,51.50853,{"lat":156,"lon":155},[159],{"name":160,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Kin Sheng Lim",{"facility":162,"status":34,"city":150,"state":10,"zip":10,"country":151,"countryCode":152,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"Moorfields Eye Hospital NHS Foundation Trust",{"type":39,"coordinates":164},[155,156],{"lat":156,"lon":155},[167],{"name":168,"role":25,"phone":10,"phoneExt":10,"email":10},"Prof. Gus Gazzard",{"type":170,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100611054","preserflo-microshunt-xi-observational-pmcf-study-with-no-control-group-100611054",false,"NCT07235592","PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group","Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma","Inclusion Criteria:\n\n1. Male or female, age 18 to 85 years, inclusive\n2. Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications\n3. Patient willing to comply with study requirements\n4. Patient who has signed an approved informed consent form\n\nExclusion Criteria:\n\n1. Angle closure glaucoma\n2. Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)\n3. Active iris neovascularization\n4. Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)\n5. Vitreous in the anterior chamber\n6. Presence of an anterior chamber intraocular lens (ACIOL)\n7. Intraocular silicone oil\n8. Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period\n9. Central corneal thickness that is less than 450 microns or greater than 620 microns\n10. Previous cilioablative procedure\n11. Neovascular glaucoma\n12. Uveitic Glaucoma\n13. Pseudoexfoliative or pigmentary glaucoma\n14. Chronic inflammation\n15. Previous incisional ophthalmic surgery within 6 months prior to study\n16. Enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam\n17. Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the patient at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the Protocol","ALL","18 Years","85 Years",{"count":182,"type":183},112,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and\u002For where glaucoma progression warrants surgery.",[187],"Primary Open Angle Glaucoma",[189],"POAG","2026-05-28",{"date":192,"type":193},"2026-05-29","ACTUAL",{"date":195,"type":193},"2026-03-19",{"date":197,"type":183},"2027-09",{"name":5,"class":6},11]