Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change in ocular rigidity
研究概览
简要总结
It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.
In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.
In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.
The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).
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
- •Men and women aged over 18 years
- •Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
- •Patients scheduled for trabeculectomy
排除标准
- •Participation in a clinical trial in the 3 weeks preceeding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- •Other types of glaucoma, such as pigmentary glaucoma, history of acute angle closure
- •History of previous glaucoma surgery
- •Postoperative IOP ≤ 8 mmHg
- •Ocular inflammation or infection within the past 3 months
- •Topical treatment with any ophthalmic drug except anti-glaucomatous medication
结局指标
主要结局
Change in ocular rigidity
时间窗: Baseline and 28±7 days postoperative
Change in ocular rigidity after surgery
次要结局
- Pulse rate(Baseline and 28±7 days postoperative)
- choroidal thickness(Baseline and 28±7 days postoperative)
- Mean arterial pressure(Baseline and 28±7 days postoperative)
- Axial eye length(Baseline and 28±7 days postoperative)
- Fundus pulsation amplitude(Baseline and 28±7 days postoperative)
- Ocular pulse amplitude(Baseline and 28±7 days postoperative)
研究者
Gerhard Garhofer
Assoc.Prof. Priv.-Doz. MD
Medical University of Vienna