NCT01461291

Brief Summary

Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 16, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

5.6 years

First QC Date

October 25, 2011

Last Update Submit

May 18, 2022

Conditions

Primary Open-angle Glaucoma

Keywords

Primary open-angle glaucomaPOAGTrabecular meshworkiStent inject

Outcome Measures

Primary Outcomes (1)

  • ≥ 20% Reduction in Intraocular Pressure (IOP)

    Baseline and Month 24

Secondary Outcomes (1)

  • Diurnal IOP Reduction from Baseline

    Baseline and Month 24

Other Outcomes (1)

  • Safety follow-up post-PMA to be through 36 months

    36 months

Study Arms (2)

iStent inject

EXPERIMENTAL

Implantation of two GTS400 stents using G2-M-IS iStent inject

Device: iStent inject

Cataract surgery

ACTIVE COMPARATOR

Cataract surgery alone

Procedure: Cataract surgery

Interventions

iStent injectDEVICE

Implantation of two GTS400 stents using G2-M-IS iStent inject

iStent inject
Cataract surgeryPROCEDURE

Cataract surgery alone

Cataract surgery

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pigmentary or pseudoexfoliative glaucoma
  • Prior incisional glaucoma surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kerry Stephens, O.D.

    Glaukos Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 28, 2011

Study Start

January 16, 2012

Primary Completion

August 4, 2017

Study Completion

October 1, 2018

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

US(1)