5 Years Long Term Results After Standalone CyPass-Implantation

NCT ID: NCT03114059

Last Updated: 2022-07-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-04-01

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.

Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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standalone CyPass implantation

patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago

Glaucoma diagnostics

Intervention Type DIAGNOSTIC_TEST

Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Interventions

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Glaucoma diagnostics

Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Intervention Type DIAGNOSTIC_TEST

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dietrich-Bonhoeffer-Klinikum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helmut Hoeh, MD,FEBO

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Neubrandenburg, Germany

Locations

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Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25304276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25747677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23958836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24771171 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STI 06/16

Identifier Type: -

Identifier Source: org_study_id

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