MedPath

CyPass Clinical Experience Study

Completed
Conditions
Open Angle Glaucoma (OAG)
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

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
Primary Outcome Measures
NameTimeMethod
Incidence of intraoperative and postoperative adverse eventsDay 0 - Year 3
Secondary Outcome Measures
NameTimeMethod
Intraocular pressure (IOP) reduction1 - 36 months postoperatively
Ocular hypotensive medication use1 - 36 months postoperatively

Trial Locations

Locations (14)

University Eye Clinic

🇦🇹

Salzburg, Austria

Specialized Hospital for Active Treatment of Ophthalmologic Diseases

🇧🇬

Sofia, Bulgaria

Schlosspark-Klinik, Department of Ophthalmology

🇩🇪

Berlin, Germany

Knappschaftskrankenhaus Bochum-Langendreer

🇩🇪

Bochum, Germany

AugenKlinik Cham

🇩🇪

Cham, Germany

Klinik fur Augenheilkunde, Campus Lubeck

🇩🇪

Lubeck, Germany

Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum

🇩🇪

Neubrandenburg, Germany

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio

🇮🇹

Catania, Italy

Wojskowy Instytut Medyczny (Military Medical Institute)

🇵🇱

Warsaw, Poland

Institut Catala de Retina

🇪🇸

Barcelona, Spain

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University Eye Clinic
🇦🇹Salzburg, Austria

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