One, Two, or Three iStents for the Reduction of Intraocul... | NCT01517477

Studies
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

NCT01517477

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

Aug 31, 2022Actual

Enrollment

119Actual

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma (POAG)

Interventions

iStent
iStent
iStent

Countries

Armenia

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

Aug 2022

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

Jan 2012Actual

Primary Completion Date

Oct 18, 2019Actual

Completion Date

Oct 18, 2019Actual

First Submitted Date

Jan 23, 2012

First Submission Date that Met QC Criteria

Jan 24, 2012

First Posted Date

Jan 25, 2012Estimated

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

Aug 29, 2022

Last Update Posted Date

Aug 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First Arm: One iStent	Experimental	Device: One iStent	Device: iStent
Second Arm: Two iStents	Experimental	Device: Two iStent devices	Device: iStent
Third Arm: Three iStents	Experimental	Device: Three iStent devices	Device: iStent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent	Device	Implantation of One iStent through a small temporal clear corneal incision.	First Arm: One iStent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline		12 Months

Secondary Outcomes

Measure	Description	Time Frame
Mean diurnal IOP <18 mmHg at month 12		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with primary open-angle glaucoma (POAG)
Subject on two topical hypotensive medications

Exclusion Criteria:

Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled

Accepts Healthy Volunteers

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.V. Malayan's Ophthalmology Centre		Yerevan		375108	Armenia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

18 month results published in Clinical Ophthalmology 2015:9 2313-2320.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided