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NCT00326014 Clinical Trial

A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Open-Angle Glaucoma Clinical Trial

Official title:
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00326014
Other study ID # GC-002
Secondary ID
Status Completed
Phase Phase 4
First received May 12, 2006
Last updated June 3, 2015
Start date April 2003
Est. completion date December 2009

Study information
Verified date June 2015
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

Description:

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date December 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with primary open-angle glaucoma (POAG)

- Subject on at least one glaucoma medication

- Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)

- Angle closure glaucoma

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• iStent
Glaucoma Surgery

Locations
Country Name City State
Germany Klinik Vincentinum Augsburg
Germany Universitats Augenklinik Freiburg
Germany Rotkreuz Krankenhaus München
Germany Klinikum Neubrandenburg Neubrandenburg
Germany Augenaerztliche Gemeinschaftspraxis Weinheim
Spain Clinico San Carlos Madrid
Spain Instituto Oftalmológico de Aragón Zaragoza
Switzerland Augenklinik Kantonsspital Winterthur

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

References & Publications (2)

Spiegel D, García-Feijoó J, García-Sánchez J, Lamielle H. Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther. 2008 May;25(5):453-64. doi: 10.1007/s12325-008-0062-6. — View Citation

Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, Garcia-Feijoo J, Martinez-De-La-Casa JM, Garcia-Sanchez J. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009 May-Jun;19(3):393-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy 24 months No
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