A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
1 other identifier
interventional
58
3 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2003
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 8, 2015
June 1, 2015
4.9 years
May 12, 2006
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
24 months
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on at least one glaucoma medication
- Patient requiring cataract surgery and an intraocular lens implantation
You may not qualify if:
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Klinik Vincentinum
Augsburg, 86150, Germany
Universitats Augenklinik
Freiburg im Breisgau, 79106, Germany
Rotkreuz Krankenhaus
München, 80637, Germany
Klinikum Neubrandenburg
Neubrandenburg, 17033, Germany
Augenaerztliche Gemeinschaftspraxis
Weinheim, D69469, Germany
Clinico San Carlos
Madrid, 28040, Spain
Instituto Oftalmológico de Aragón
Zaragoza, 50007, Spain
Augenklinik Kantonsspital
Winterthur, CH-8401, Switzerland
Related Publications (2)
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. doi: 10.1177/112067210901900311.
PMID: 19396784BACKGROUNDSpiegel D, Garcia-Feijoo J, Garcia-Sanchez 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.
PMID: 18594784BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Head of clinical Affairs
Glaukos Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 16, 2006
Study Start
April 1, 2003
Primary Completion
March 1, 2008
Study Completion
December 1, 2009
Last Updated
June 8, 2015
Record last verified: 2015-06