5 Years Long Term Results After Standalone CyPass-Implantation

Completed

Conditions: Glaucoma

Interventions: Diagnostic Test: Glaucoma diagnostics

Registration Number: NCT03114059

Lead Sponsor: Dietrich-Bonhoeffer-Klinikum

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standalone CyPass implantation	Glaucoma diagnostics	patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago

Primary Outcome Measures

Name	Time	Method
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg	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)	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	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	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 Outcome Measures

Name	Time	Method
Number of Participants With Intra-and Postoperative Complications	up to 7 years	The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
Number of Participants With Stability of Optic Nerve	up to 7 years	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.
Number of Participants With Stability of Visual Field	up to 7 years	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.
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness	up to 7 years	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.
Number of Participants With Stability of Stent Position	up to 7 years	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
Number of Participants With Suprachoroidal Bleb	up to 7 years	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
Number of Participants With Stability of Stent Tissue Interaction	up to 7 years	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.