Decorin as an Antifibrotic Agent in Sub Scleral Trabeculectomy: A Pilot Study
试验速览
- 阶段
- 1 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- success of trabeculectomy
研究概览
简要总结
This is a prospective, single-center, interventional, randomized controlled study comparing Decorin as antifibrotic agent in sub scleral trabeculectomy versus Mitomycin.
详细描述
Study design:
This is a prospective, single-center, interventional, randomized controlled study at Kasr Al Aini Teaching Hospital, Cairo University. Patients with medically uncontrolled glaucoma will be enrolled in our study.
Fifty two consecutive eyes with Primary Open-angle Glaucoma indicated for trabeculectomy will be enrolled in the current study and will be then randomly assigned to our interventions. Informed consent will be obtained from all patients before any intervention. Uncontrolled glaucoma was defined as uncontrolled IOP (≥22 mm Hg) measured with a Goldmann applanation tonometer under maximal tolerable medical treatment with visual field defect progression. Exclusion criteria will include patients with history of intraocular surgery within the previous 6 months, patients with history of surgery involving the conjunctiva, angle closure glaucoma, and patient refusal to take part in the study.
Data Collected:
Preoperative:
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
- Single (Outcomes Assessor)
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
- •Primary Open Angle Glaucoma
排除标准
- •Secondary Glaucoma, Closed angle glaucoma
研究组 & 干预措施
Decorin Group
26 patients will receive subconjunctival injection of 100 µg decorin 15 minutes before surgery, 1, 3, and 7postoperatively. A30-gauge needle was used to inject 100 µL of decorin. The needle was placed at the nasal margin of the superior rectus muscle
干预措施: Decorin (Drug)
Mitomycin Group
MMC will then be applied in 26 patients to the sclera at a concentration of 0.3 mg/ml using cellulose sponges, which will be removed after 3 minutes followed by copious irrigation with balanced saline solution (BSS).
干预措施: Mitomycin c (Drug)
结局指标
主要结局
success of trabeculectomy
时间窗: one year
complete if the IOPis≤ 21 mm Hg without medications
次要结局
未报告次要终点
研究者
abdussalam abdullatif, MD
Lecturer
Cairo University