[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603991":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":25},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No Amniotic Membrane Group","ACTIVE_COMPARATOR","Patients receive standard glaucoma surgery (PreserFlo MicroShunt or XEN Stent) without additional covering. The choice between PreserFlo or XEN is not part of the study design-it's determined beforehand by the surgeon as part of regular care.",[13],"Other: Glaucoma Surgery without Amniotic Membrane",{"label":15,"type":16,"description":17,"interventionNames":18},"Amniotic Membrane Group","EXPERIMENTAL","Patients receive standard glaucoma surgery (PreserFlo MicroShunt or XEN Stent) with additional covering. The implanted MicroShunt or Stent is covered with an amniotic membrane patch. The choice between PreserFlo or XEN is not part of the study design-it's determined beforehand by the surgeon as part of regular care.",[19],"Other: Glaucoma Surgery with Amniotic Membrane",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Glaucoma Surgery with Amniotic Membrane","Arm 2: Glaucoma Surgery with Amniotic Membrane Participants undergo glaucoma surgery with either a PreserFlo MicroShunt or a XEN Stent, as determined by the treating surgeon. In this group, the implanted stent is covered with an amniotic membrane patch to reduce postoperative scarring and improve long-term outcomes. Follow-up visits are scheduled as per standard of care for glaucoma surgery (up to 12 months).",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Glaucoma Surgery without Amniotic Membrane","Arm 1: Glaucoma Surgery without Amniotic Membrane Participants undergo glaucoma surgery with either a PreserFlo MicroShunt or a XEN Stent, as determined by the treating surgeon. No modifications are made to the procedure. Follow-up visits are scheduled as per standard of care for glaucoma surgery (up to 12 months).",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Lesya Shuba, MD","CONTACT","1-902-473-3410","LSHUBA@DAL.CA",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Lesya Shuba","Principal Investigator","100603991","safety-and-effectiveness-of-preserflo-and-xen-stents-with-or-without-amniotic-membrane-in-glaucoma-surgery-100603991",false,"NCT07143708","Safety and Effectiveness of PreserFlo and XEN Stents With or Without Amniotic Membrane in Glaucoma Surgery","Comparison of the Safety and Efficacy of PreserFlo MicroShunt and XEN Stent Alone Versus With Amniotic Membrane in Glaucoma Surgery","Inclusion Criteria:\n\n1. Age 18 years and older\n2. Patients selected for PreserFlo microshunt surgery and XEN stent alone or in combination with cataract surgery.\n3. Ability to comprehend the study procedures\n\nExclusion Criteria:\n\n1. Unwilling or unable to give consent\n2. Unable to come for scheduled post-operative visits\n3. Pregnant or nursing women\n4. Previous cyclodestructive procedures, scleral buckling procedures, or presence of silicone oil\n5. Conjunctival scarring precluding a glaucoma surgery superiorly\n6. Active iris neovascularization or active proliferative retinopathy\n7. Vitreous in the anterior chamber for which a vitrectomy is anticipated.\n8. Previous trabeculectomy, tube-shunt implantation, or surgeries that shunt aqueous outflow into the subconjunctival space","ALL","18 Years",{"count":50,"type":51},156,"ESTIMATED","INTERVENTIONAL",[54],"NA","Glaucoma is one of the leading causes of permanent blindness in the world. It happens when the optic nerve-the connection between the eye and the brain-is damaged. As this damage gets worse, vision is slowly lost.\n\nGlaucoma treatments often begin with eye drops to lower eye pressure. If drops are not enough, surgery may be needed. The type of surgery depends on how advanced the glaucoma is and how much vision has already been lost.\n\nSome glaucoma surgeries, including trabeculectomy, PreserFlo MicroShunt, and XEN Stent, create a new pathway for fluid to drain out of the eye. This helps lower pressure inside the eye.\n\nHowever, after surgery, the body's natural healing process can sometimes cause inflammation and scarring, which may block the new drainage pathway. If this happens, eye pressure can rise again, and the surgery may not work as well as hoped.\n\nThis study is testing whether covering the PreserFlo or XEN devices with amniotic membrane (a safe tissue already used in other eye surgeries) can reduce scarring, improve healing, and lead to better long-term results. Amniotic membrane has already been used safely in many types of eye surgeries. It has been shown to improve healing and reduce scarring in some glaucoma surgeries. But it has not yet been studied in PreserFlo MicroShunt or XEN Stent procedures. The goal is to see if adding amniotic membrane makes the surgery safer and more effective for people with glaucoma.",[57],"Glaucoma",[59,60,61,62],"Galucoma","Glaucoma Surgery","Stent surgery","MicroShunt surgery","NOT_YET_RECRUITING","2025-08-20",{"date":66,"type":67},"2025-08-27","ACTUAL",{"date":69,"type":51},"2025-12-01",{"date":71,"type":51},"2027-12-31",{"name":5,"class":6}]