5 Years Long Term Results After Standalone CyPass-Implantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation

Conditions
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Glaucoma

Intervention / Treatment
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* Diagnostic Test: Glaucoma diagnostics


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| standalone CyPass implantation<br>patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago | Diagnostic Test: Glaucoma diagnostics<br>* Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg | 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. | up to 7 years | 
| Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) | 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 | up to 7 years | 
| Number of Additional Medication | 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 | up to 7 years | 
| Number of Participants With Secondary Glaucoma Procedures | To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented | up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stability of Optic Nerve | The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure. With papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings. | up to 7 years | 
| Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness | The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success. | up to 7 years | 
| Number of Participants With Stability of Visual Field | The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field. | up to 7 years | 
| Number of Participants With Stability of Stent Position | Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space | up to 7 years | 
| Number of Participants With Stability of Stent Tissue Interaction | Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed. | up to 7 years | 
| Number of Participants With Intra-and Postoperative Complications | The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure | up to 7 years | 
| Number of Participants With Suprachoroidal Bleb | The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent | up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late Effects of Surgery