Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
There will be no blinding of the ophthalmologist to participant's study group as they will need the information to execute the correct intervention. The type of treatment received (mitomycin-C or no intervention) will be blinded for the patient, and all patients will be asked at the last follow-up visit which treatment location they felt they received. This data will be used to assess the level of treatment masking. The success of blinding will be calculated using Bang's Blinding Index. The person performing statistical analysis will be blinded to the intervention groups. The groups will be coded and the analyst will be unaware of which group receives mitomycin-C or no intervention with the Ahmed valve implant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mitomycin-C Treatment
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.
干预措施: Mitomycin c (Drug)
结局指标
主要结局
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
时间窗: 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.
次要结局
- Number of Glaucoma Medications assessed by reviewing of patient medication records(Baseline to 1-year follow-up visit)
- Visual Acuity assessed using the Snellen chart.(Baseline to 1-year follow-up visit)
- Anterior Chamber Inflammation assessed using the Slit-lamp examination(Baseline to 1-year follow-up visit)
- Progression to Surgical Therapy measured using clinical evaluation and surgical records.(Baseline to 1-year follow-up visit)
研究者
Enitan Sogbesan
Doctor
St. Joseph's Healthcare Hamilton