Status:

COMPLETED

Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Lead Sponsor:

Glaukos Corporation

Conditions:

Open-angle Glaucoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate...

Detailed Description

The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, c...

Eligibility Criteria

Inclusion

  • Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
  • Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion

  • Not meeting inclusion criteria

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT00721968

Start Date

March 1 2007

End Date

August 1 2012

Last Update

March 6 2014

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