Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 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 to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy 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. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 and older (Adult, Older Adult)
- •patients with confirmed uncontrolled open angle glaucoma
- •no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
排除标准
- •angle closure glaucoma
- •congenital glaucoma
- •inflammatory glaucoma
结局指标
主要结局
success rate (complete and qualified success)
时间窗: 24 months
Success is defined: 1. IOP \< 21 mmHg and at least 20% IOP change from baseline 2. IOP \< 18 mmHg
次要结局
- IOP, medication, complications(24 months)
研究者
Joanna Konopińska
Head of Ophthalomogy, Principal Investigator, Clinical Professor
Medical University of Bialystok
