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临床试验/NCT06925412
NCT06925412已完成不适用

Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月1日最近更新:

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hazem Elbadry Mohammed Mohammed

Lecturer of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Al-Azhar University

研究点 (2)

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