24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy With Collagen Implant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Effect of DSCI 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 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 with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.
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
- •Diagnosis of POAG
- •Documented glaucomatous VF damage with mean defect (MD) > 3 dB
- •Progressing glaucomatous damage justifying a DSCI
- •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
结局指标
主要结局
Effect of DSCI 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 patients with POAG * before DSCI * 3 months after DSCI.
次要结局
- Safety and tolerability(3 months)
- Changes in visual field 3 months after DSCI(3 months)
- Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern(3 months)