Glaukos® iStent® Trabecular Micro-Bypass Stent System In... | NCT01841437 | Trialant

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Glaukos® iStent® Trabecular Micro-Bypass Stent System In... | NCT01841437 | Trialant

Studies
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

NCT01841437

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

Dec 18, 2017Actual

Enrollment

191Actual

Phase

Not provided

Conditions

Primary Open-angle Glaucoma

Interventions

iStent

Countries

United States

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

NCT01841437

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

GTS100-PAR

Secondary IDs

Not provided

Brief Title

Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

Official Title

Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

Acronym

Not provided

Organization

Glaukos CorporationINDUSTRY

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Sep 2013

Primary Completion Date

Feb 16, 2016Actual

Completion Date

Jun 21, 2016Actual

First Submitted Date

Apr 24, 2013

First Submission Date that Met QC Criteria

Apr 25, 2013

First Posted Date

Apr 26, 2013Estimated

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

Dec 14, 2017

Last Update Posted Date

Dec 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Glaukos CorporationINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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 observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Detailed Description

Not provided

Conditions Module

Conditions

Primary Open-angle Glaucoma

Keywords

Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

36 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iStent			Device: iStent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent	Device		iStent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of sight-threatening adverse events		36 months

Secondary Outcomes

Measure	Description	Time Frame
Other ocular adverse events		36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

Please refer to approved indications in Directions for Use

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Chico	California	95926	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Cohort

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Huntington Beach

California

92647

United States

Napa

California

94558

United States

Santa Maria

California

93454

United States

Ventura

California

93003

United States

Parker

Colorado

80134

United States

Portland

Maine

04102

United States

Quincy

Massachusetts

02169

United States

Bloomington

Minnesota

55431

United States

Westwood

New Jersey

07675

United States

Durham

North Carolina

27710

United States

Fayetteville

North Carolina

28304

United States

Southern Pines

North Carolina

28387

United States

Brecksville

Ohio

44141

United States

Youngstown

Ohio

44502

United States

Ladson

South Carolina

29456

United States

Sioux Falls

South Dakota

57108

United States

Appleton

Wisconsin

54914

United States

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided