[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07520175":3,"trial-entities:NCT07520175":115,"trial-summary:NCT07520175":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":24,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":47,"locations":51,"central_contacts":107,"overall_officials":108,"references":113,"see_also_links":114},"NCT07520175","ITR-CAN-041","A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma","An Observational Study of Safety and Effectiveness Outcomes Following Bio-Reinforced Canaloplasty for Trabecular Outflow Enhancement in Eyes With Open-Angle Glaucoma (The BOOST Study)","ENROLLING_BY_INVITATION","2029-12","2026-07","2026-07-22","2026-04-01","Iantrek, Inc.","INDUSTRY",false,"The goal of this study is to learn about outcomes after bio-reinforced canaloplasty surgery in patients with OAG. The key question the study aims to answer is:\n\nHow much does the surgical procedure lower pressure inside the eye and what is the durability of this effect?\n\nParticipants will return for periodic eye exams for 2 years following surgery.","The purpose of this observational study is to evaluate postoperative outcomes in a real-world setting after bio-reinforced canaloplasty in eyes with OAG. Outcomes of interest include change in intraocular pressure (IOP), change in use of glaucoma medications, related adverse events, and surgical reinterventions for additional IOP control.\n\nPatients will be approached for study enrollment based on investigator determination that surgical intervention is necessary to maintain target IOP and the patient may benefit from bio-reinforced canaloplasty.\n\nAfter surgery, data will be collected from participant examinations on Day 1 and at approximately 1, 3, 6, 12, 18 and 24 months. Examinations at each visit are performed per the investigator's standard of care.",[19],"Open-Angle Glaucoma",[21,22],"bio-reinforced canaloplasty","open-angle glaucoma","OBSERVATIONAL",null,[],{"count":27,"type":28},300,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","AlloSpan Canal Platform Bio-Reinforced Canaloplasty","A canaloplasty procedure is performed using AlloSpan Canal manual surgical instrumentation. After canaloplasty, minimally manipulated, homologous-use scleral allograft tissue is placed within in the canal-wall region of the Schlemm's canal lumen to provide structural reinforcement.",[35],"Bio-reinforced canaloplasty",[37],{"measure":38,"description":39,"timeFrame":40},"Mean change in IOP","Mean change in IOP as compared to baseline without increase in IOP-lowering medications or secondary IOP-lowering surgery","12 months, 24 months",[],"ALL",{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"Inclusion Criteria:\n\n1\\. Diagnosis of OAG in the study eye and a candidate for bio-reinforced canaloplasty for aqueous outflow enhancement, as determined by investigator\n\nExclusion Criteria:\n\n1\\. Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, or neovascular glaucoma in the study eye 2. Previous minimally invasive or filtering glaucoma surgery in the study eye 3. Previous IOP-lowering procedure ≤ 12 weeks prior to bio-reinforced canaloplasty in the study eye 5. Previous investigational, or non-standard of care procedures and\u002For treatments ≤ 12 weeks prior to bio-reinforced canaloplasty\n\n\\-",[48,49,50],"CHILD","ADULT","OLDER_ADULT",[52,61,68,76,84,92,100],{"facility":53,"city":54,"state":55,"zip":56,"country":57,"geoPoint":58},"North Valley Eye Care","Chico","California","95928","United States",{"lat":59,"lon":60},39.72849,-121.83748,{"facility":62,"city":63,"state":55,"zip":64,"country":57,"geoPoint":65},"North Bay Eye Associates","Petaluma","94954",{"lat":66,"lon":67},38.23242,-122.63665,{"facility":69,"city":70,"state":71,"zip":72,"country":57,"geoPoint":73},"Twin Cities Eye Consultants","Coon Rapids","Minnesota","55433",{"lat":74,"lon":75},45.11997,-93.28773,{"facility":77,"city":78,"state":79,"zip":80,"country":57,"geoPoint":81},"Cataract & Laser Institute","Medford","Oregon","97504",{"lat":82,"lon":83},42.32652,-122.87559,{"facility":85,"city":86,"state":87,"zip":88,"country":57,"geoPoint":89},"Scott & Christie Eyecare Associates","Cranberry Township","Pennsylvania","16066",{"lat":90,"lon":91},40.68496,-80.10714,{"facility":93,"city":94,"state":95,"zip":96,"country":57,"geoPoint":97},"Key-Whitman Eye Center","Dallas","Texas","75243",{"lat":98,"lon":99},32.78306,-96.80667,{"facility":101,"city":102,"state":95,"zip":103,"country":57,"geoPoint":104},"El Paso Eye Surgeons","El Paso","79922",{"lat":105,"lon":106},31.75872,-106.48693,[],[109],{"name":110,"affiliation":111,"role":112},"Tsontcho Ianchulev, MD, MPH","Chief Medical Officer","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Open Angle Glaucoma",[],{"nct_id":4,"found":15,"summary":24,"prompt_version":24}]