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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461291

Enrollment

505

Registered

2011-10-28

Start date

2012-01-16

Completion date

2018-10-31

Last updated

2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-angle Glaucoma

Keywords

Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject

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.

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.

Interventions

DEVICEiStent inject

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

PROCEDURECataract surgery

Cataract surgery alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Diurnal IOP Reduction from Baseline	Baseline and Month 24

Other

Measure	Time frame
Safety follow-up post-PMA to be through 36 months	36 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026