CyPass Clinical Experience Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01097174

Acronym

CyCLE

Enrollment

555

Registered

2010-04-01

Start date

2009-12-31

Completion date

2015-07-31

Last updated

2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma (OAG)

Keywords

Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure

Brief summary

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

Interventions

DEVICECyPass 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.

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of intraoperative and postoperative adverse events	Day 0 - Year 3

Secondary

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

Countries

Austria, Bulgaria, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026