[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05506423":3,"trial-entities:NCT05506423":185,"trial-summary:NCT05506423":188},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":47,"locations":50,"central_contacts":174,"overall_officials":175,"references":179,"see_also_links":184},"NCT05506423","ITR-CYC-041","Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes","An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma","ACTIVE_NOT_RECRUITING","2027-12","2026-07","2026-07-22","2022-08-17","Iantrek, Inc.","INDUSTRY",false,"This observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery.\n\nData regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.","This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled.\n\nData will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use.\n\nSpecific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.",[19],"Open Angle Glaucoma",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},300,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","CycloPen Cyclodialysis System","The CycloPen Micro-Interventional Cyclodialysis System is used to create a cyclodialysis cleft and deliver allograft scleral tissue and\u002For viscous material within the cleft for endoscleral reinforcement.",[33,34],"CycloPen Cyclodialysis System in conjunction with cataract surgery","CycloPen Cyclodialysis System in standalone surgery",[36],{"measure":37,"description":38,"timeFrame":39},"Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline","Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery","12 months postoperative",[],"ALL","21 Years",{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"To be included, participants must have:\n\n1. Open angle glaucoma\n2. IOP-lowering surgical procedure using the CycloPen System\n\nThere are no exclusionary criteria.",[48,49],"ADULT","OLDER_ADULT",[51,60,68,75,82,90,98,105,113,121,128,135,143,151,159,167],{"facility":52,"city":53,"state":54,"zip":55,"country":56,"geoPoint":57},"Visionary Eye Institute","Newport Beach","California","92663","United States",{"lat":58,"lon":59},33.61891,-117.92895,{"facility":61,"city":62,"state":63,"zip":64,"country":56,"geoPoint":65},"Tyson Eye","Cape Coral","Florida","33904",{"lat":66,"lon":67},26.56285,-81.94953,{"facility":69,"city":70,"state":63,"zip":71,"country":56,"geoPoint":72},"Central Florida Eye Specialists","DeLand","32720",{"lat":73,"lon":74},29.02832,-81.30312,{"facility":76,"city":77,"state":63,"zip":78,"country":56,"geoPoint":79},"Eye Associates of Ft. Myers","Fort Myers","33912",{"lat":80,"lon":81},26.62168,-81.84059,{"facility":83,"city":84,"state":85,"zip":86,"country":56,"geoPoint":87},"Omni Eye Services","Atlanta","Georgia","30342",{"lat":88,"lon":89},33.749,-84.38798,{"facility":91,"city":92,"state":93,"zip":94,"country":56,"geoPoint":95},"Eye Doctors of Washington","Chevy Chase","Maryland","20815",{"lat":96,"lon":97},39.00287,-77.07115,{"facility":99,"city":100,"state":93,"zip":101,"country":56,"geoPoint":102},"Visionary Eye Doctors","Rockville","20852",{"lat":103,"lon":104},39.084,-77.15276,{"facility":106,"city":107,"state":108,"zip":109,"country":56,"geoPoint":110},"Center for Sight","Las Vegas","Nevada","89145",{"lat":111,"lon":112},36.17497,-115.13722,{"facility":114,"city":115,"state":116,"zip":117,"country":56,"geoPoint":118},"Wilton Center for Advanced Eyecare","New Brunswick","New Jersey","07728",{"lat":119,"lon":120},40.48622,-74.45182,{"facility":122,"city":123,"state":123,"zip":124,"country":56,"geoPoint":125},"North Manhattan Eye Center","New York","10034",{"lat":126,"lon":127},40.71427,-74.00597,{"facility":129,"city":130,"state":123,"zip":131,"country":56,"geoPoint":132},"Buffalo Ophthalmology","Williamsville","14221",{"lat":133,"lon":134},42.96395,-78.73781,{"facility":136,"city":137,"state":138,"zip":139,"country":56,"geoPoint":140},"James S Lewis, MD","Fort Washington","Pennsylvania","19034",{"lat":141,"lon":142},40.14178,-75.20906,{"facility":144,"city":145,"state":146,"zip":147,"country":56,"geoPoint":148},"Eye Centers of Tennessee","Crossville","Tennessee","38555",{"lat":149,"lon":150},35.94896,-85.0269,{"facility":152,"city":153,"state":154,"zip":155,"country":56,"geoPoint":156},"Ophthalmology Associates","Fort Worth","Texas","76102",{"lat":157,"lon":158},32.72541,-97.32085,{"facility":160,"city":161,"state":162,"zip":163,"country":56,"geoPoint":164},"John Moran Eye Center - U of Utah","Salt Lake City","Utah","84132",{"lat":165,"lon":166},40.76078,-111.89105,{"facility":168,"city":169,"country":170,"geoPoint":171},"Panama Eye Center","Panama City","Panama",{"lat":172,"lon":173},8.9936,-79.51973,[],[176],{"name":177,"affiliation":13,"role":178},"Tsontcho Ianchulev, MD,MPH","STUDY_CHAIR",[180],{"pmid":181,"type":182,"citation":183},"40799662","DERIVED","Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi: 10.1177\u002F25158414251362010. eCollection 2025 Jan-Dec.",[],{"nct_id":4,"conditions":186,"biomarkers":187},[19],[],{"nct_id":4,"found":15,"summary":22,"prompt_version":22}]