Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intraocular pressure (IOP) reduction
研究概览
简要总结
Glaucoma is a leading cause of irreversible blindness worldwide, with intraocular pressure (IOP) reduction being the primary therapeutic goal. Trabeculectomy, augmented with mitomycin C (MMC), remains the gold standard surgical intervention but is limited by postoperative fibrosis. MMC delivery methods, including sponge application and sub-Tenon injection, vary in drug distribution and may influence surgical outcomes. This study aimed to compare the efficacy and safety of trabeculectomy using sponge-applied MMC versus sub-Tenon MMC injection, focusing on IOP reduction, bleb morphology, and postoperative medication requirements.
In this retrospective, randomized controlled trial, 50 patients with primary or secondary glaucoma were assigned to trabeculectomy with either MMC sponge application (Group A, n=25) or sub-Tenon MMC injection (Group B, n=25). All surgeries were performed by the same surgeon using standardized techniques. Patients were followed for one year, with primary outcomes including IOP reduction and secondary outcomes encompassing bleb morphology (Indiana Bleb Appearance Grading Scale), bleb integrity (Seidel test), and postoperative glaucoma medication use.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older,
- •diagnosed with primary open-angle glaucoma (POAG) or secondary glaucoma,
- •uncontrolled IOP (IOP > 21 mmHg) despite maximally tolerated medical therapy,
- •progressive visual field deterioration,
- •or intolerance to anti-glaucoma medications.
排除标准
- •age under 18 years,
- •absence of light perception,
- •previous incisional glaucoma surgery,
- •need for combined ocular procedures,
- •intraoperative use of 5-fluorouracil (5-FU),
- •or follow-up duration of less than one month
结局指标
主要结局
Intraocular pressure (IOP) reduction
时间窗: One year
次要结局
- Bleb morphology (Indiana Bleb Appearance Grading Scale)(One year)
- Bleb integrity (Seidel test)(One year)
- Postoperative glaucoma medication use(One year)
研究者
Hazem Elbadry Mohammed Mohammed
Lecturer of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt
Al-Azhar University
