[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472997":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Paracelsus Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"XEN Glaucoma Gel Microstent (AbbVie) Device","ACTIVE_COMPARATOR","Implantation of XEN Glaucoma Gel Microstent (Device, AbbVie) for the treatment of glaucoma will be performed in this arm. It is a newer filtering glaucoma surgery. XEN Glaucoma Gel Microstent implantation accounts to the filtering glaucoma surgeries.",[13],"Device: surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Trabeculectomy","Trabeculectomy will be performed in this arm. Trabeculecomy is the classic filtering glaucoma surgery since more than 50 years for the treatment of glaucoma (gold standard within the filtering glaucoma surgery group).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","surgery","2 types of filtering glaucoma surgeries (classic trabeculectomy as gold standard, and newer XEN glaucoma microstent) are compared against each other in a prospective multicentric randomized study",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Herbert Reitsamer, MD","Paracelsus Medical University Salzburg\u002F Salzburger Landeskliniken","STUDY_CHAIR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Markus Lenzhofer, MD PhD","CONTACT","+43 5 7255","24201","m.lenzhofer@salk.at",{"name":27,"role":33,"phone":34,"phoneExt":35,"email":38},"h.reitsamer@salk.at",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Dept. Ophthalmology and Optometry Paracelsus Medical University","RECRUITING","Salzburg","5020","Austria","AT",{"type":48,"coordinates":49},"Point",[50,51],13.04399,47.79941,{"lat":51,"lon":50},[54],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},{"type":56,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Prof. Dr. Herbert Reitsamer","100472997","xen-glaucoma-gel-stent-versus-trabeculectomy-100472997",false,"NCT05439161","XEN Glaucoma Gel Stent Versus Trabeculectomy","Multicentric Evaluation of Best Corrected Visual Acuity of the XEN Implant Versus Classic Trabeculectomy in Open Angle Glaucoma Subjects","Inclusion Criteria:\n\n1. Diagnosis of open angle glaucoma (Primary open angle glaucoma, Pseudoexfoliation glaucoma, Pigmentary dispersion glaucoma)\n2. Clinically eligible for both surgeries (Trabeculectomy and XEN) on the discretion of the surgeon (area of healthy, free and mobile conjunctiva in the superior nasal target quadrant)\n3. VA logMAR ≤ 1 (VA dec ≥ 0.1)\n4. Trabecular meshwork must be visible (with Shaffer angle grade \\> 1 in the target quadrant)\n5. Age 18 years or older\n6. Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent\n\nExclusion Criteria:\n\n1. Clinical significant cataract\n2. Subject has had prior cataract surgery in study eye ≤ 1 months (count to operation)\n3. Subject has had prior (incisional) glaucoma surgery (XEN, trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.). Prior iridotomy is acceptable.\n4. Phacic Angle Closure Glaucoma\n5. Subject has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders\n6. Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)\n7. Anterior chamber intraocular lens\n8. Vitreous present in the anterior chamber\n9. Presence of intraocular silicone oil\n10. History of corneal surgery, corneal opacities, or corneal disease\n11. Impaired episcleral venous drainage (e.g. Sturge-Weber or nanophthalmos)\n12. History of dermatologic keloid formation\n13. Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, or other ophthalmic disease or disorder that could confound study results\n14. Known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde),\n15. Pregnant or nursing women","ALL","18 Years",{"count":68,"type":69},196,"ESTIMATED","INTERVENTIONAL",[72],"NA","Multicentric evaluation of best corrected visual acuity of the XEN implant versus classic trabeculectomy in open angle glaucoma subjects",[75,76,77],"Primary Open Angle Glaucoma","Pseudoexfoliation Glaucoma","Pigmentary Dispersion Glaucoma","2025-05-28",{"date":80,"type":81},"2025-06-03","ACTUAL",{"date":83,"type":81},"2023-12-20",{"date":85,"type":69},"2026-09-30",{"name":57,"class":6},1]