Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Sponsor
Glaukos Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01461291
Collaborator
(none)
505
1
2
80.5
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: iStent inject
  • Procedure: Cataract surgery
N/A

Detailed Description

The purpose of this study is to 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, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Study Design

Study Type:
Interventional
Actual Enrollment :
505 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Actual Study Start Date :
Jan 16, 2012
Actual Primary Completion Date :
Aug 4, 2017
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: iStent inject

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

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

Active Comparator: Cataract surgery

Cataract surgery alone

Procedure: Cataract surgery
Cataract surgery alone

Outcome Measures

Primary Outcome Measures

  1. ≥ 20% Reduction in Intraocular Pressure (IOP) [Baseline and Month 24]

Secondary Outcome Measures

  1. Diurnal IOP Reduction from Baseline [Baseline and Month 24]

Other Outcome Measures

  1. Safety follow-up post-PMA to be through 36 months [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Pigmentary or pseudoexfoliative glaucoma

  • Prior incisional glaucoma surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Centers of Racine and Kenosha Racine Wisconsin United States 53405

Sponsors and Collaborators

  • Glaukos Corporation

Investigators

  • Study Chair: Kerry Stephens, O.D., Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01461291
Other Study ID Numbers:
  • GC-008
First Posted:
Oct 28, 2011
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Keywords provided by Glaukos Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022