NCT01460017Unknown1 期
Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- reduction in IOP
研究概览
简要总结
The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.
详细描述
Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.
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, Care Provider)
入排标准
- 年龄范围
- 1 Day 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
- •Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
- •Within the age of (0 - 12).
排除标准
- •Cases of congenital glaucoma with previous intervention.
- •Age above 12 Yrs.
- •Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
结局指标
主要结局
reduction in IOP
时间窗: 6 month
decrease in the intraocular pressure to the normal limit (\<22 - \>6) mmHg
次要结局
未报告次要终点
研究者
Dr. Ahmed Mousa
Lecturer
King Saud University
研究点 (2)
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