CyPass Clinical Experience Study

Transcend Medical, Inc.555 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

555

Conditions

Open Angle Glaucoma (OAG)

Interventions

CyPass Micro-StentDEVICE

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

Sex: ALL

Medical Language ↔ Plain English

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

Locations (14)

University Eye Clinic

Salzburg, Austria

Specialized Hospital for Active Treatment of Ophthalmologic Diseases

Sofia, Bulgaria

Schlosspark-Klinik, Department of Ophthalmology

Berlin, Germany

Outcomes

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

Data from ClinicalTrials.gov

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