Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
研究概览
简要总结
This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery
详细描述
This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure . They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have undergone a standalone cypass implantation at least 3 years ago
- •signed inform consent
排除标准
- •Patients with too much travel distance between study center and home
- •Patients who cannot visit the studycenter due to health problems
结局指标
主要结局
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
时间窗: up to 7 years
The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
时间窗: up to 7 years
The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg) The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point
Number of Additional Medication
时间窗: up to 7 years
The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent. The postoperative number of medications after 5 years has to be compared with the preoperative number
Number of Participants With Secondary Glaucoma Procedures
时间窗: up to 7 years
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
次要结局
- Number of Participants With Intra-and Postoperative Complications(up to 7 years)
- Number of Participants With Stability of Optic Nerve(up to 7 years)
- Number of Participants With Stability of Visual Field(up to 7 years)
- Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness(up to 7 years)
- Number of Participants With Stability of Stent Position(up to 7 years)
- Number of Participants With Suprachoroidal Bleb(up to 7 years)
- Number of Participants With Stability of Stent Tissue Interaction(up to 7 years)