[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07480343":3,"trial-entities:NCT07480343":144,"trial-summary:NCT07480343":148},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":48,"minimum_age":25,"maximum_age":25,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":53,"locations":57,"central_contacts":137,"overall_officials":138,"references":142,"see_also_links":143},"NCT07480343","ITR-CYC-042","5-Year Postoperative Outcomes of Patients Who Completed the CREST Study","FIVE-YEAR POSTOPERATIVE OUTCOMES IN PATIENTS WITH OPEN-ANGLE GLAUCOMA WHO UNDERWENT BIO-INTERVENTIONAL UVEOSCLERAL OUTFLOW ENHANCEMENT SURGERY: LONG-TERM OBSERVATIONAL FOLLOW-UP FROM THE CREST STUDY (THE CREST-XT STUDY)","ENROLLING_BY_INVITATION","2030-12","2026-07","2026-07-21","2025-09-15","Iantrek, Inc.","INDUSTRY",false,"This study is designed to collect clinical data at 3, 4, and 5 years postoperatively for participants who completed the CREST Study without having secondary IOP-lowering surgery in the study eye(s).","This is a multicenter, prospective, observational study following eligible participants who completed the CREST Study. Participants who consent to participate will have clinical data gathered from annual ophthalmic examinations through 60 months after CycloPen System surgery for analysis of long-term outcomes. As an observational study, examinations at each visit are performed per the investigator's standard of care.",[19],"Open-angle Glaucoma (OAG)",[21,22,23],"Bio-interventional cyclodialysis","AlloFlo","CycloPen","OBSERVATIONAL",null,[],{"count":28,"type":29},250,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","CycloPen Micro-Interventional Cyclodialysis System","The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and\u002For viscous material to reinforce and maintain the cleft postoperatively.",[36],"Bio-reinforced Cyclodialysis alone",{"type":32,"name":38,"description":39,"armGroupLabels":40},"CycloPen Micro-Interventional Cyclodialysis System Post Cataract","After cataract surgery, the CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and\u002For viscous material to reinforce and maintain the cleft postoperatively.",[41],"Bio-reinforced Cyclodialysis in conjunction with cataract surgery",[43],{"measure":44,"description":45,"timeFrame":46},"Mean change in intraocular pressure (IOP)","Mean change in intraocular pressure (IOP) measured using tonometry","From before bio-interventional cyclodialysis to 60 months after surgery",[],"ALL",{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\n1. Diagnosis of open-angle glaucoma (OAG) in the study eye(s), including pigmentary and pseudoexfoliative glaucoma, at the time of CREST enrollment\n2. Completed participation in CREST\n3. Provide signed written consent using the Institutional Review Board (IRB)\u002FEthics Committee (EC) approved study-specific informed consent form (ICF)\n4. Ability, comprehension, and willingness to follow study instructions\n\nExclusion Criteria:\n\n1. Systemic disease that, in the opinion of the Investigator, would put participant's health at risk and\u002For prevent completion of required study visits\n2. Early termination from CREST\n3. Secondary surgical intervention for long-term IOP control in the study eye(s)",[54,55,56],"CHILD","ADULT","OLDER_ADULT",[58,67,75,82,90,98,105,113,121,129],{"facility":59,"city":60,"state":61,"zip":62,"country":63,"geoPoint":64},"CREST-XT Site 05","Newport Beach","California","92663","United States",{"lat":65,"lon":66},33.61891,-117.92895,{"facility":68,"city":69,"state":70,"zip":71,"country":63,"geoPoint":72},"CREST-XT Site 03","Cape Coral","Florida","33904",{"lat":73,"lon":74},26.56285,-81.94953,{"facility":76,"city":77,"state":70,"zip":78,"country":63,"geoPoint":79},"CREST-XT Site 10","DeLand","32720",{"lat":80,"lon":81},29.02832,-81.30312,{"facility":83,"city":84,"state":85,"zip":86,"country":63,"geoPoint":87},"CREST-XT Site 07","Atlanta","Georgia","30342",{"lat":88,"lon":89},33.749,-84.38798,{"facility":91,"city":92,"state":93,"zip":94,"country":63,"geoPoint":95},"CREST-XT Site 12","Chevy Chase","Maryland","20815",{"lat":96,"lon":97},39.00287,-77.07115,{"facility":99,"city":100,"state":93,"zip":101,"country":63,"geoPoint":102},"CREST-XT Site 13","Rockville","20852",{"lat":103,"lon":104},39.084,-77.15276,{"facility":106,"city":107,"state":108,"zip":109,"country":63,"geoPoint":110},"CREST-XT Site 16","Las Vegas","Nevada","89145",{"lat":111,"lon":112},36.17497,-115.13722,{"facility":114,"city":115,"state":116,"zip":117,"country":63,"geoPoint":118},"CREST-XT Site 01","Fort Washington","Pennsylvania","19034",{"lat":119,"lon":120},40.14178,-75.20906,{"facility":122,"city":123,"state":124,"zip":125,"country":63,"geoPoint":126},"CREST-XT Site 04","Crossville","Tennessee","38555",{"lat":127,"lon":128},35.94896,-85.0269,{"facility":130,"city":131,"state":132,"zip":133,"country":63,"geoPoint":134},"CREST-XT Site 11","Salt Lake City","Utah","84132",{"lat":135,"lon":136},40.76078,-111.89105,[],[139],{"name":140,"affiliation":13,"role":141},"Tsontcho Ianchulev, MD, MPH","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":145,"biomarkers":147},[146],"Open Angle Glaucoma",[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]