NCT03114059

5 Years Long Term Results After Standalone CyPass-Implantation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Dietrich-Bonhoeffer-Klinikum · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Glaucoma diagnostics	Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-02-28
• Completion: 2020-04-01
• First posted: 2017-04-14
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

1 site across 1 country: Germany