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

Primary Purpose

Open-Angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
iStent
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open angle, Glaucoma, Cataract, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik Vincentinum
  • Universitats Augenklinik
  • Rotkreuz Krankenhaus
  • Klinikum Neubrandenburg
  • Augenaerztliche Gemeinschaftspraxis
  • Clinico San Carlos
  • Instituto Oftalmológico de Aragón
  • Augenklinik Kantonsspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
June 3, 2015
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00326014
Brief Title
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Official Title
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma
Keywords
Open angle, Glaucoma, Cataract, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
iStent
Other Intervention Name(s)
Glaukos iStent
Intervention Description
Glaucoma Surgery
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of clinical Affairs
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Klinik Vincentinum
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Universitats Augenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Rotkreuz Krankenhaus
City
München
ZIP/Postal Code
80637
Country
Germany
Facility Name
Klinikum Neubrandenburg
City
Neubrandenburg
ZIP/Postal Code
17033
Country
Germany
Facility Name
Augenaerztliche Gemeinschaftspraxis
City
Weinheim
ZIP/Postal Code
D69469
Country
Germany
Facility Name
Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Oftalmológico de Aragón
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain
Facility Name
Augenklinik Kantonsspital
City
Winterthur
ZIP/Postal Code
CH-8401
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19396784
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. doi: 10.1177/112067210901900311.
Results Reference
background
PubMed Identifier
18594784
Citation
Spiegel 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.
Results Reference
background

Learn more about this trial

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

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