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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Diagnostic test: Glaucoma diagnostics

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.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg/Vorpommern
    • Neubrandenburg, Mecklenburg/Vorpommern, Germany, 17036
      • Dietrich-Bonhoeffer-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

130 Patient with at least one treated eye

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
standalone CyPass implantation; patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago	Diagnostic test: Glaucoma diagnostics; Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dietrich-Bonhoeffer-Klinikum
• Investigators: Principal Investigator: Helmut Hoeh, MD,FEBO, Department of Ophthalmology, Neubrandenburg, Germany

Publications and helpful links

General Publications

• Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.
• Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.
• Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.
• Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Late Effects of Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: STI 06/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: results will be published in ophthalmological journals
• IPD Sharing Time Frame: results are planned to published in December 2020
• IPD Sharing Access Criteria: Publication in ophthalmological journals provided and checked by Ahmed Medra

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No