Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- IOP
研究概览
简要总结
The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.
详细描述
The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •individuals ≥ 18 years of age
- •clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
- •uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
- •progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p < 0.05)
- •progression of visual field defects
- •visually significant cataract and indication to reduce IOP or glaucoma medication burden
排除标准
- •clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
- •prior glaucoma surgery
- •preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
研究组 & 干预措施
Trabeculopuncture
Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy.
干预措施: Trabeculopuncture (Diagnostic Test)
结局指标
主要结局
IOP
时间窗: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Intraocular pressure measured by Goldmann applanation tonometry
Outflow facility
时间窗: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Outflow facility is measured by the use of a pneumatonometer
Surgical success
时间窗: at month three
surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops
次要结局
未报告次要终点