CyPass Clinical Experience Study (CyCLE)

May 12, 2017 updated by: Transcend Medical, Inc.

A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • University Eye Clinic
  • Bulgaria
      • Sofia, Bulgaria
        • Specialized Hospital for Active Treatment of Ophthalmologic Diseases
  • Germany
      • Berlin, Germany
        • Schlosspark-Klinik, Department of Ophthalmology
      • Bochum, Germany
        • Knappschaftskrankenhaus Bochum-Langendreer
      • Cham, Germany
        • AugenKlinik Cham
      • Lubeck, Germany
        • Klinik fur Augenheilkunde, Campus Lubeck
      • Neubrandenburg, Germany
        • Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum
  • Italy
      • Catania, Italy
        • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio
  • Poland
      • Warsaw, Poland
        • Wojskowy Instytut Medyczny (Military Medical Institute)
  • Spain
      • Barcelona, Spain
        • Institut Català de Retina
      • Barcelona, Spain
        • Instituto de Microcirugia Ocular
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Ramon y Cajal University Hospital
      • Zaragoza, Spain
        • Hospital Universiatrio Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Glaucoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of intraoperative and postoperative adverse events
Time Frame: Day 0 - Year 3
Day 0 - Year 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure (IOP) reduction
Time Frame: 1 - 36 months postoperatively
1 - 36 months postoperatively
Ocular hypotensive medication use
Time Frame: 1 - 36 months postoperatively
1 - 36 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Medical, Inc.

Investigators

  • Study Director: Tsontcho (Sean) Ianchulev, MD, MPH, Transcend Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMI-09-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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