[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568363":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":32,"collaborators":18,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":18,"enrollmentInfo":46,"targetDuration":18,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":61,"whyStopped":18,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":18},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mitomycin-C Treatment","EXPERIMENTAL","The intervention aims to assess the efficacy of Mitomycin-C in preventing postoperative hypertensive phases by inhibiting fibroblast proliferation around the surgical site. Patients in this arm will receive a 0.2 mg\u002FmL Mitomycin-C injection into the sclera during Ahmed Glaucoma Valve implantation surgery. The total volume of the injection will be 1 mL, administered once intraoperatively.",[13],"Drug: Mitomycin c",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Patients in this arm will undergo the Ahmed Glaucoma Valve implantation surgery without the addition of Mitomycin-C. This group serves as a control to evaluate the effects of the Ahmed Valve alone in managing intraocular pressure in patients with refractory glaucoma. Postoperative care remains consistent with the experimental group, involving the same regimen of topical antibiotics and steroids.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Mitomycin c","Patients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced glaucoma specialist performs the surgery, injecting 0.2 mg\u002Fml mitomycin-C into the sclera for the experimental group, while the control group receives no intervention. The area is irrigated with 40mL balanced salt solution before implant insertion. Post-operative care includes topical antibiotics and steroids for six weeks, with follow-ups at 1 and 2 weeks, and 1, 3, 6, and 12 months to monitor visual acuity, IOP, anterior chamber reaction, complications, and additional glaucoma medications.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Sharan Bains","CONTACT","905-522-1155","38505","bainss@mcmaster.ca",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Enitan Sogbesan","Doctor","100568363","phase-3-effect-of-mitomycin-c-on-the-outcomes-of-patients-receiving-ahmed-glaucoma-valve-implantation-surgery-100568363",false,"NCT06680245","Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery","MMC","Inclusion Criteria:\n\n* Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome\n* Participant must be over 18 years of age\n* IOP \\> 16mmHg on at least two consecutive occasions separated by one month\n* Two sighted eyes with visual acuity of 20\u002F200 or better\n* Informed consent from patient\n\nExclusion Criteria:\n\n* Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma\n* Previous incisional glaucoma surgery\n* Incisional glaucoma surgery scheduled within 1 year of intervention\n* Corneal disease affecting visualization of anterior chamber of the eye\n* Treatment or plan to treat with topical or systemic steroids\n* Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)\n* Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.",true,"ALL","18 Years",{"count":47,"type":48},144,"ESTIMATED","INTERVENTIONAL",[51],"PHASE3","The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are:\n\nDoes intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases?\n\nResearchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications.\n\nParticipants will:\n\n* Undergo baseline assessment including eye examination and measurement of intraocular pressure.\n* Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery.\n* Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.",[54],"Glaucoma",[56,57,58,59,60],"Refractory Glaucoma","Intraocular Pressure","Ahmed Glaucoma Valve","Mitomycin-C","Glaucoma Surgery","NOT_YET_RECRUITING","2024-11-06",{"date":64,"type":65},"2024-11-08","ACTUAL",{"date":67,"type":48},"2024-12-01",{"date":69,"type":48},"2026-12-01",{"name":5,"class":6}]