A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.
研究概览
简要总结
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.
The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of POAG
- •Documented glaucomatous VF damage with mean defect (MD) > 3 dB
- •Progressing glaucomatous damage justifying a DS
- •Aged ≥18 years, of either sex
- •Not more than 4 diopters spherical equivalent on the study eye
- •Not more than 2 diopters cylinder equivalent on the study eye
- •Have given written informed consent, prior to any investigational procedures
排除标准
- •Corneal or conjunctival abnormality precluding contact lens adaptation
- •Severe dry eye syndrome
- •Patients with allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Patients not able to understand the character and individual consequences of the investigation
- •Participation in other clinical research within the last 4 weeks
- •Any other contra-indication listed in the Triggerfish user manual
结局指标
主要结局
Effect of DS on IOP fluctuation profile as recorded by Triggerfish in patients with POAG.
时间窗: 3 months
The IOP fluctuation profile will be recorded by Triggerfish in patient with POAG * Before DS * 3 months after DS
次要结局
- Safety and Tolerability(3 months)
- Changes in visual field up to 6 months after DS(3 months)
- effect of DS on the diurnal and nocturnal IOP fluctuation pattern(3 months)