Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Dietrich-Bonhoeffer-Klinikum
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients who have undergone a standalone cypass implantation at least 3 years ago
- •signed inform consent
Exclusion Criteria
- •Patients with too much travel distance between study center and home
- •Patients who cannot visit the studycenter due to health problems
Outcomes
Primary Outcomes
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)