5 Years Long Term Results After Standalone CyPass-Implantation

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114059
• Other study ID #: STI 06/16
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2018
• Source: Dietrich-Bonhoeffer-Klinikum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: April 1, 2020
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Diagnostic Test:
• Glaucoma diagnostics
Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Locations

Country	Name	City	State
Germany	Dietrich-Bonhoeffer-Klinikum	Neubrandenburg	Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Dietrich-Bonhoeffer-Klinikum

Country where clinical trial is conducted

Germany, 

References & Publications (4)

García-Feijoo J, Rau M, Grisanti S, Grisanti S, Höh 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. — View Citation

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. German. — View Citation

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. — View Citation

Höh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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