[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651008":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":63,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Benha University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Innovative Tube Trabeculectomy (ITT)","EXPERIMENTAL","Patients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation.",[13],"Procedure: Innovative Tube Trabeculectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Conventional Trabeculectomy","ACTIVE_COMPARATOR","Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site).",[19],"Procedure: Conventional Trabeculectomy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Innovative Tube Trabeculectomy",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Trabeculectomy","Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site",[15],[31],{"name":32,"affiliation":5,"role":33},"Tarek Abulnasr, MD","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Ahmed M Saeed, MD","CONTACT","01227468426","ahmed.abdelhamid@fmed.bu.edu.eg",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ophthalmology department, Faculty of Medicine, Benha University","RECRUITING","Banhā","13518","Egypt","EG",{"type":49,"coordinates":50},"Point",[51,52],31.1842,30.45977,{"lat":52,"lon":51},[55,59,61],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":58},"Mohamed G AlAshhab, MD","0133227518","info@fmed.bu.edu.eg",{"name":32,"role":60,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":36,"role":62,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ahmed Mohamed Saeed Abdel Hamid","Principal investigator","100651008","innovative-tube-trabeculectomy-for-advanced-and-refractory-glaucoma-a-randomized-controlled-trial-100651008",false,"NCT07755761","Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial","A Prospective, Randomized, Controlled, Single-Center Clinical Trial to Evaluate the Efficacy and Safety of Innovative Tube Trabeculectomy Compared to Conventional Trabeculectomy in Patients With Advanced and Refractory Glaucoma","ITT-RCT","Inclusion Criteria:\n\n\\- • Diagnosis of advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma).\n\n* Intraocular pressure (IOP) \\> 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery.\n* Best corrected visual acuity (BCVA) of 20\u002F400 or better.\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).\n* Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).\n* Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).\n* Pregnancy or lactation.\n* Participation in another clinical trial within 30 days prior to enrollment.","ALL","18 Years",{"count":77,"type":78},116,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma. ITT incorporates a unique preoperative regimen and surgical modifications, including a deep extended scleral tunnel, X-shaped non-absorbable suture, and a nasolacrimal tube implant, designed to enhance aqueous humor outflow and reduce postoperative fibrosis. Participants will be randomized to receive either ITT or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.",[84,85,86],"Glaucoma","Trabeculectomy","Innovative Procedures",[88,89,90],"glaucoma","innovative","tube trabeculectomy","2026-08-05",{"date":93,"type":94},"2026-08-10","ACTUAL",{"date":96,"type":94},"2026-08-01",{"date":98,"type":78},"2028-08-01",{"name":5,"class":6},1]