CyPass Clinical Experience Study
CyCLE
A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
1 other identifier
observational
555
6 countries
14
Brief Summary
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMay 15, 2017
October 1, 2016
5.6 years
March 30, 2010
May 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of intraoperative and postoperative adverse events
Day 0 - Year 3
Secondary Outcomes (2)
Intraocular pressure (IOP) reduction
1 - 36 months postoperatively
Ocular hypotensive medication use
1 - 36 months postoperatively
Study Arms (1)
CyPass Micro-stent
Patients in whom CyPass Micro-stent implantation was attempted.
Interventions
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.
Eligibility Criteria
Glaucoma
You may qualify if:
- Diagnosis of OAG
- IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)
You may not qualify if:
- Acute angle closure, narrow angle, uveitic or neovascular glaucoma
- Normal tension glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University Eye Clinic
Salzburg, Austria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases
Sofia, Bulgaria
Schlosspark-Klinik, Department of Ophthalmology
Berlin, Germany
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, Germany
AugenKlinik Cham
Cham, Germany
Klinik fur Augenheilkunde, Campus Lubeck
Lübeck, Germany
Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, Germany
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio
Catania, Italy
Wojskowy Instytut Medyczny (Military Medical Institute)
Warsaw, Poland
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tsontcho (Sean) Ianchulev, MD, MPH
Transcend Medical, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2010
First Posted
April 1, 2010
Study Start
December 1, 2009
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
May 15, 2017
Record last verified: 2016-10