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

Glaukos

Status: Completed

Conditions: Primary Open-angle Glaucoma

Treatments: Device: iStent inject; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461291

GC-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 505 patients

Sex: All

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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505 participants in 2 patient groups

iStent inject

Experimental group

Description:

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

Treatment:

Device: iStent inject

Cataract surgery

Active Comparator group

Description:

Cataract surgery alone

Treatment:

Procedure: Cataract surgery