CyPass Clinical Experience Study (CyCLE)
This study is ongoing, but not recruiting participants.
Sponsor:
Transcend Medical, Inc.
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01097174
First received: March 30, 2010
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.
| Condition | Intervention |
|---|---|
|
Open Angle Glaucoma (OAG) |
Device: CyPass Micro-Stent |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Transcend Medical, Inc.:
Primary Outcome Measures:
- Incidence of intraoperative and postoperative adverse events [ Time Frame: Day 0 - Year 3 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Intraocular pressure (IOP) reduction [ Time Frame: 1 - 36 months postoperatively ] [ Designated as safety issue: No ]
- Ocular hypotensive medication use [ Time Frame: 1 - 36 months postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CyPass Micro-stent |
Device: 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.
Other Names:
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097174
Locations
| Austria | |
| University Eye Clinic | |
| Salzburg, Austria | |
| Bulgaria | |
| Specialized Hospital for Active Treatment of Ophthalmologic Diseases | |
| Sofia, Bulgaria | |
| Germany | |
| 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 | |
| Italy | |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio | |
| Catania, Italy | |
| Poland | |
| Wojskowy Instytut Medyczny (Military Medical Institute) | |
| Warsaw, Poland | |
| Spain | |
| Instituto de Microcirugia Ocular | |
| Barcelona, Spain | |
| Institut Catala de Retina | |
| Barcelona, Spain | |
| Hospital Clinico San Carlos | |
| Madrid, Spain | |
| Ramón y Cajal University Hospital | |
| Madrid, Spain | |
| Hospital Universiatrio Miguel Servet | |
| Zaragoza, Spain | |
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
| Study Director: | Tsontcho (Sean) Ianchulev, MD, MPH | Transcend Medical, Inc. |
More Information
No publications provided
| Responsible Party: | Transcend Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01097174 History of Changes |
| Other Study ID Numbers: | TMI-09-02 |
| Study First Received: | March 30, 2010 |
| Last Updated: | July 5, 2012 |
| Health Authority: | Austria: Ethikkommission Germany: Ethics Commission Bulgaria: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Italy: Ministero della Salute Australia: Australian Government Department of Health & Aging - Therapeutic Good Administration Spain: Comité Ético de Investigación Clínica |
Keywords provided by Transcend Medical, Inc.:
|
Glaucoma Glaucoma device Glaucoma surgery Intraocular pressure |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013