CyPass Clinical Experience Study

Completed

• Conditions: Open Angle Glaucoma (OAG)
• Interventions: Device: CyPass Micro-Stent

• Registration Number: NCT01097174
• Lead Sponsor: Transcend Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-04-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CyPass Micro-stent	CyPass Micro-Stent	Patients in whom CyPass Micro-stent implantation was attempted.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative and postoperative adverse events	Day 0 - Year 3

Secondary Outcome Measures

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

Trial Locations

Locations (14)

University Eye Clinic; 🇦🇹 Salzburg, Austria

Schlosspark-Klinik, Department of Ophthalmology; 🇩🇪 Berlin, Germany

AugenKlinik Cham; 🇩🇪 Cham, Germany

Knappschaftskrankenhaus Bochum-Langendreer; 🇩🇪 Bochum, Germany

Klinik fur Augenheilkunde, Campus Lubeck; 🇩🇪 Lubeck, Germany

Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum; 🇩🇪 Neubrandenburg, Germany

Wojskowy Instytut Medyczny (Military Medical Institute); 🇵🇱 Warsaw, Poland

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio; 🇮🇹 Catania, Italy

Institut Catala de Retina; 🇪🇸 Barcelona, Spain

Instituto de Microcirugia Ocular; 🇪🇸 Barcelona, Spain

Ramón y Cajal University Hospital; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universiatrio Miguel Servet; 🇪🇸 Zaragoza, Spain

Specialized Hospital for Active Treatment of Ophthalmologic Diseases; 🇧🇬 Sofia, Bulgaria