CyPass Clinical Experience Study (CyCLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Transcend Medical, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01097174
First received: March 30, 2010
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Open Angle Glaucoma (OAG)
Device: CyPass Micro-Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience

Resource links provided by NLM:


Further study details as provided by Transcend Medical, Inc.:

Primary Outcome Measures:
  • Incidence of intraoperative and postoperative adverse events [ Time Frame: Day 0 - Year 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraocular pressure (IOP) reduction [ Time Frame: 1 - 36 months postoperatively ] [ Designated as safety issue: No ]
  • Ocular hypotensive medication use [ Time Frame: 1 - 36 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: December 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyPass Micro-stent 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.
Other Names:
  • CyPass 2FX
  • CyPass 211 System

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Instituto de Microcirugia Ocular
Barcelona, Spain
Institut Catala de Retina
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.
  More Information

No publications provided

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01097174     History of Changes
Other Study ID Numbers: TMI-09-02
Study First Received: March 30, 2010
Last Updated: July 5, 2012
Health Authority: Austria: Ethikkommission
Germany: Ethics Commission
Bulgaria: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministero della Salute
Australia: Australian Government Department of Health & Aging - Therapeutic Good Administration
Spain: Comité Ético de Investigación Clínica

Keywords provided by Transcend Medical, Inc.:
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

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

ClinicalTrials.gov processed this record on July 26, 2014