[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569231":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Davinci LTD","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 that includes Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma Patients",null,"This cohort includes patients diagnosed with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) who have undergone suprachoroidal silicone tube (SST) shunt implantation. The study focuses on assessing the long-term safety and efficacy of the SST shunt, monitoring intraocular pressure (IOP) control, endothelial cell count (ECC) changes, and any adverse events over an extended follow-up period. This observational cohort includes patients aged 41-88 years, treated with the SST shunt either alone or in combination with cataract surgery, and meeting the inclusion criteria from a prior retrospective study.",[13],"Device: Suprachoroidal silicone tube (SST) shunt",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Suprachoroidal silicone tube (SST) shunt","This intervention involves implanting a modified suprachoroidal silicone tube (SST) shunt, derived from the Aurolab Aqueous Drainage Device (AADI), to lower intraocular pressure in patients with primary open-angle and pseudoexfoliative glaucoma. The SST shunt, measuring 13.0-15.0 mm with a 0.3 mm inner and 0.6 mm outer diameter, is designed to reach the posterior suprachoroidal space. Six slits near the distal end aid aqueous outflow. Implantation involves creating a scleral flap, accessing the SCS, and placing the distal end in the SCS and proximal end in the anterior chamber (AC). The shunt is secured with sutures, and viscoelastic is injected into the AC to prevent hypotony. No antimetabolites or cautery are used.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Nikoloz Labauri, MD. FVRS","CONTACT","+995599003744","nlabauri@yahoo.com",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Davinci Eye Center, LTD","RECRUITING","Tbilisi","0160","Georgia","GE",{"type":35,"coordinates":36},"Point",[37,38],44.83412,41.69143,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100569231","long-term-safety-and-efficacy-of-a-modified-suprachoroidal-silicone-tube-sst-shunt-100569231",false,"NCT06691555","Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt","The Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt in Patients with Primary Open-angle Glaucoma (POAG) and Pseudo-exfoliative Glaucoma (PXG) Over an Extended Follow-up Period","Inclusion Criteria:\n\n* Previously were treated with Suprachoroidal silicone tube shunt\n* Willing and able to participate in this cross sectional observational follow up\n* Participant capable of giving informed consent\n\nExclusion Criteria:\n\n* Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator","ALL","40 Years","90 Years",{"count":55,"type":56},66,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the long-term safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in treating patients with primary open-angle glaucoma (POAG) and pseudo-exfoliative glaucoma (PXG).\n\nThe main questions it aims to answer are:\n\nDoes the SST shunt maintain intraocular pressure (IOP) reduction over an extended follow-up period? What is the effect of the SST shunt on endothelial cell count (ECC) and overall corneal health?\n\nParticipants will:\n\nUndergo intraocular pressure (IOP) measurements Have their endothelial cell count (ECC) evaluated Complete assessments of best corrected visual acuity (BCVA) Be assessed for C\u002FD ratio Be monitored for adverse events or shunt-related complications over time",[60,61,62,63,64,65],"Glaucoma","Open Angle Glaucoma (OAG)","POAG","Ocular Hypertension","Exfoliation Syndrome","Choroidal Effusions",[67,68,60,69,70,71,72],"MIGS","Suprachoroidal Space","Open-Angle Glaucoma","Suprachoroidal Silicone Tube","Suprachoroidal Shunt","Glaucoma Shunt","2024-11-14",{"date":75,"type":76},"2024-11-15","ACTUAL",{"date":78,"type":76},"2024-11-08",{"date":80,"type":56},"2024-11-30",{"name":5,"class":6},1]