Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
- Registration Number
- NCT06680245
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP > 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Corneal disease affecting visualization of anterior chamber of the eye
- Treatment or plan to treat with topical or systemic steroids
- Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
- Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mitomycin-C Treatment Mitomycin c 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.
- Primary Outcome Measures
Name Time Method Change in Intraocular Pressure assessed using the Goldmann applanation tonometer Baseline to 1-year follow-up visit 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.
- Secondary Outcome Measures
Name Time Method Number of Glaucoma Medications assessed by reviewing of patient medication records Baseline to 1-year follow-up visit 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.
Visual Acuity assessed using the Snellen chart. Baseline to 1-year follow-up visit 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.
Anterior Chamber Inflammation assessed using the Slit-lamp examination Baseline to 1-year follow-up visit 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.
Progression to Surgical Therapy measured using clinical evaluation and surgical records. Baseline to 1-year follow-up visit The progression to surgical therapy in each group will be compared from baseline to 1-year follow-up.