CyPass Clinical Experience Study

NCT ID: NCT01097174

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

555 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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Conditions

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Open Angle Glaucoma (OAG)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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CyPass Micro-stent

Patients in whom CyPass Micro-stent implantation was attempted.

CyPass Micro-Stent

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Transcend Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsontcho (Sean) Ianchulev, MD, MPH

Role: STUDY_DIRECTOR

Transcend Medical, Inc.

Locations

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University Eye Clinic

Salzburg, , Austria

Site Status

Specialized Hospital for Active Treatment of Ophthalmologic Diseases

Sofia, , Bulgaria

Site Status

Schlosspark-Klinik, Department of Ophthalmology

Berlin, , Germany

Site Status

Knappschaftskrankenhaus Bochum-Langendreer

Bochum, , Germany

Site Status

AugenKlinik Cham

Cham, , Germany

Site Status

Klinik fur Augenheilkunde, Campus Lubeck

Lübeck, , Germany

Site Status

Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, , Germany

Site Status

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio

Catania, , Italy

Site Status

Wojskowy Instytut Medyczny (Military Medical Institute)

Warsaw, , Poland

Site Status

Institut Catala de Retina

Barcelona, , Spain

Site Status

Instituto de Microcirugia Ocular

Barcelona, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Ramón y Cajal University Hospital

Madrid, , Spain

Site Status

Hospital Universiatrio Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Austria Bulgaria Germany Italy Poland Spain

Other Identifiers

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TMI-09-02

Identifier Type: -

Identifier Source: org_study_id

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