Multicenter Investigation of the Glaukos® Suprachoroidal... | NCT01461278

Studies
Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

NCT01461278

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

May 19, 2022Actual

Enrollment

505Actual

Phase

Not Applicable

Conditions

Primary Open-angle Glaucoma

Interventions

iStent supra
Cataract surgery

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

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

May 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

Dec 22, 2011Actual

Primary Completion Date

Mar 13, 2019Actual

Completion Date

Mar 12, 2020Actual

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 26, 2011

First Posted Date

Oct 28, 2011Estimated

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

May 18, 2022

Last Update Posted Date

May 19, 2022Actual

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

Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed Description

This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

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

505Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cataract surgery plus iStent supra	Experimental		Device: iStent supra Procedure: Cataract surgery
Cataract surgery	Active Comparator		Procedure: Cataract surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent supra	Device	Cataract surgery and implantation of one iStent supra	Cataract surgery plus iStent supra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
≥ 20% Reduction in Intraocular Pressure (IOP)		Baseline and Month 24

Secondary Outcomes

Measure	Description	Time Frame
Diurnal IOP Reduction from Baseline		Baseline and Month 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate open-angle glaucoma
Characteristics consistent with mild to moderate glaucoma
Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

Pigmentary or pseudoexfoliative glaucoma
Prior incisional glaucoma surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 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
Kerry Stephens, O.D.	Glaukos Corporation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Centers of Racine and Kenosha		Racine	Wisconsin	53405	United States

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D000080324	Choroidal Effusions

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D005124	Eye Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided