跳至主要内容
临床试验/NCT05366647
NCT05366647招募中不适用

Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment

Medical University of Bialystok2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月1日最近更新:
适应症

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

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

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanna Konopińska

Head of Ophthalomogy, Principal Investigator, Clinical Professor

Medical University of Bialystok

研究点 (2)

Loading locations...

相似试验