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

Primary Open-angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461291
• Other study ID #: GC-008
• Status: Completed
• Phase: N/A
• Start date: January 16, 2012
• Est. completion date: October 2018

Study information

• Verified date: May 2022
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: October 2018
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

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

Procedure:
• Cataract surgery
Cataract surgery alone

Locations

Country	Name	City	State
United States	Eye Centers of Racine and Kenosha	Racine	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety follow-up post-PMA to be through 36 months		36 months
Primary	= 20% Reduction in Intraocular Pressure (IOP)		Baseline and Month 24
Secondary	Diurnal IOP Reduction from Baseline		Baseline and Month 24