CyPass Clinical Experience Study

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

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Key information

Conditions

Open Angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

University Eye Clinic, Salzburg, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CyPass Micro-Stent

Device

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 outcomes

Incidence of intraoperative and postoperative adverse events

Time frame: Day 0 - Year 3

Secondary outcomes

Intraocular pressure (IOP) reduction

Time frame: 1 - 36 months postoperatively
Ocular hypotensive medication use

Time frame: 1 - 36 months postoperatively

Sponsors and collaborators

Lead sponsor

Transcend Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: CyCLE

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Apr 1, 2010
Registry last updated: May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting