Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- success rate (complete and qualified success)
研究概览
简要总结
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
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 (Participant)
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
- •diagnosed primary or secondary open-angle glaucoma
- •IOP > 16 mmHg (<60 days prior surgery)
- •IOP > 21 mmHg
- •no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
排除标准
- •angle closure glaucoma
- •congenital glaucoma
- •combined procedures (glaucoma and cataract)
结局指标
主要结局
success rate (complete and qualified success)
时间窗: 2 years
Success is defined 1. IOP \< 21 mmHg and at least 20% IOP reduction from baseline 2. IOP \< 18 mmHg
次要结局
- IOP, medication, complications(2 years)