Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cumulative incidence of complications
研究概览
简要总结
This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.
详细描述
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=40
- •Planning to have a trabeculectomy
排除标准
- •Life threatening or debilitating disease
- •Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- •Pseudophakic lens
- •Contralateral eye already enrolled in study
研究组 & 干预措施
MMC Injection
Intervention: At the intended surgical site and about 6mm from the limbus, 0.2ml of 0.2mg/ml of mitomycin-C (MMC) will be injected subconjunctivally before peritomy
干预措施: Mitomycin-C (MMC) (Drug)
MMC Sponge Application
Intervention: After peritomy, three half-sponges soaked in 0.2mg/ml mitomycin-C (MMC) will be placed posterior to the area of intended filtration. After 2 minutes, the sponges will be removed
干预措施: Mitomycin-C (MMC) (Drug)
结局指标
主要结局
Cumulative incidence of complications
时间窗: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery
次要结局
- Cumulative incidence of complications(6 and 12 months after surgery)
- Reduction of intraocular pressure from baseline, mmHg(3, 6, and 12 months after surgery)