A Study of the Glaukos Trabecular Micro-bypass Stent in O... | NCT00326079

Studies
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

NCT00326079

Sponsor

Glaukos Corporation

Status

Unknown status

Last Update Posted

Mar 29, 2013Estimated

Enrollment

61Actual

Phase

Phase 4

Conditions

Open-Angle Glaucoma

Interventions

Stent

Countries

Austria
Germany
Spain
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

May 12, 2006

First Submission Date that Met QC Criteria

May 12, 2006

First Posted Date

May 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma.

Detailed Description

The study compares 1 stent versus 2 stents.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Device: Stent
2	Active Comparator		Device: Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stent	Device	implantation of 1 Glaukos iStent versus 2 Glaukos iStents	1 2

Measure	Description	Time Frame
Efficacy		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with open-angle glaucoma (OAG)
Subject on at least one glaucoma medication
Signed informed consent

Exclusion Criteria:

Angle closure glaucoma
Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
Fellow eye already enrolled

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Head of Clinical Affairs	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Medical University		Vienna		A-1090	Austria
Klinik Vincentinum

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015607	Stents

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided