CyPass Clinical Experience Study

Open Angle Glaucoma (OAG) Clinical Trial

— CyCLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097174
• Other study ID #: TMI-09-02
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: May 12, 2017
• Start date: December 2009
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma (OAG)

Intervention

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.

Locations

Country	Name	City	State
Austria	University Eye Clinic	Salzburg
Bulgaria	Specialized Hospital for Active Treatment of Ophthalmologic Diseases	Sofia
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
Italy	Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio	Catania
Poland	Wojskowy Instytut Medyczny (Military Medical Institute)	Warsaw
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

Sponsors (1)

Lead Sponsor	Collaborator
Transcend Medical, Inc.

Countries where clinical trial is conducted

Austria,  Bulgaria,  Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative and postoperative adverse events		Day 0 - Year 3
Secondary	Intraocular pressure (IOP) reduction		1 - 36 months postoperatively
Secondary	Ocular hypotensive medication use		1 - 36 months postoperatively