NCT06680245

Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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: Does 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? Researchers 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. Participants will: * Undergo baseline assessment including eye examination and measurement of intraocular pressure. * Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery. * 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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
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/ml 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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-11-08
• Last updated: 2024-11-08