A Study of the Trabecular Micro-Bypass Stent in Combinati... | NCT00326014

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

NCT00326014

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

Jun 8, 2015Estimated

Enrollment

58Actual

Phase

Phase 4

Conditions

Open-Angle Glaucoma

Interventions

iStent

Countries

Germany
Spain
Switzerland

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Mar 2008Actual

Completion Date

Dec 2009Actual

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

Jun 3, 2015

Last Update Posted Date

Jun 8, 2015Estimated

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

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)

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

58Actual

Label	Type	Description	Intervention Names
A	Experimental		Device: iStent

Name	Type	Description	Arm Group Labels	Other Names
iStent	Device	Glaucoma Surgery	A	Glaukos iStent

Measure	Description	Time Frame
Efficacy		24 months

Eligibility Module

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

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
Klinik Vincentinum		Augsburg		86150	Germany
Universitats Augenklinik

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19396784	Background	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.
18594784

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma
D002386	Cataract

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases