A Phase 3 interventional study of Mitomycin c in Glaucoma, sponsored by St. Joseph's Healthcare Hamilton. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by St. Joseph's Healthcare Hamilton · Phase 3, Interventional, and Treatment
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:
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's planned enrollment of 144 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
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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/mL 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.
Drug: Mitomycin c
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.
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.
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
The percentage decrease in intraocular pressure (IOP) from baseline will be calculated and compared between the two groups from baseline to 1-year follow-up. It will be measured using the Goldmann applanation tonometer and performed at approximately the same time of the day to account for diurnal variation. Two measurements will be averaged if the difference is less or equal to 2mmHg. If the difference is greater than 2mmHg, then three measurements will be taken and the median will be recorded. The baseline IOP will be the average of three different IOP values taken at different times of the day on at least two separate days within a period of a month. In this study, the baseline IOP will be the average IOP of previous IOP measurement and the day of surgery.
Time frame: Baseline to 1-year follow-up visit
Number of Glaucoma Medications assessed by reviewing of patient medication records
Changes in the number of glaucoma medications need per patient in each group will be compared using observations and by reviewing patient medication records from baseline to 1-year follow-up. This outcome will assess whether the intervention affects the number of prescribed glaucoma medications for the patients.
Time frame: Baseline to 1-year follow-up visit
Visual Acuity assessed using the Snellen chart.
Changes in visual acuity from baseline to 1-year follow-up will be measured using the Snellen chart. This outcome will assess whether the intervention affects the overall visual function of the patients.
Time frame: Baseline to 1-year follow-up visit
Anterior Chamber Inflammation assessed using the Slit-lamp examination
The anterior chamber inflammation at every post-operative visit will be compared to assess any complications during the surgery. This will be measured using the slit-lamp examination.
Time frame: Baseline to 1-year follow-up visit
Progression to Surgical Therapy measured using clinical evaluation and surgical records.
The progression to surgical therapy in each group will be compared from baseline to 1-year follow-up.
Time frame: Baseline to 1-year follow-up visit
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mitomycin
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