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CyPass Clinical Experience Study (CyCLE)

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ClinicalTrials.gov Identifier: NCT01097174
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Transcend Medical, Inc. )

Brief Summary:
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.

Condition or disease Intervention/treatment
Open Angle Glaucoma (OAG) Device: CyPass Micro-Stent

Study Type : Observational
Actual Enrollment : 555 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
Study Start Date : December 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
CyPass Micro-stent
Patients in whom CyPass Micro-stent implantation was attempted.
Device: CyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.



Primary Outcome Measures :
  1. Incidence of intraoperative and postoperative adverse events [ Time Frame: Day 0 - Year 3 ]

Secondary Outcome Measures :
  1. Intraocular pressure (IOP) reduction [ Time Frame: 1 - 36 months postoperatively ]
  2. Ocular hypotensive medication use [ Time Frame: 1 - 36 months postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glaucoma
Criteria

Inclusion Criteria:

  • Diagnosis of OAG
  • IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)

Exclusion Criteria:

  • Acute angle closure, narrow angle, uveitic or neovascular glaucoma
  • Normal tension glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097174


Locations
Austria
University Eye Clinic
Salzburg, Austria
Bulgaria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases
Sofia, Bulgaria
Germany
Schlosspark-Klinik, Department of Ophthalmology
Berlin, Germany
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, Germany
AugenKlinik Cham
Cham, Germany
Klinik fur Augenheilkunde, Campus Lubeck
Lubeck, Germany
Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, Germany
Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio
Catania, Italy
Poland
Wojskowy Instytut Medyczny (Military Medical Institute)
Warsaw, Poland
Spain
Institut Catala de Retina
Barcelona, Spain
Instituto de Microcirugia Ocular
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Ramón y Cajal University Hospital
Madrid, Spain
Hospital Universiatrio Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Director: Tsontcho (Sean) Ianchulev, MD, MPH Transcend Medical, Inc.

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01097174     History of Changes
Other Study ID Numbers: TMI-09-02
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: October 2016

Keywords provided by Alcon Research ( Transcend Medical, Inc. ):
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases