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

NCT01461291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Primary Open-angle Glaucoma

Interventions

DEVICE

iStent inject

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

PROCEDURE

Cataract surgery

Cataract surgery alone

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Kerry Stephens, O.D. · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-16
Primary Completion
2017-08-04
Completion
2018-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461291 on ClinicalTrials.gov