Status:

COMPLETED

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

Lead Sponsor:

Glaukos Corporation

Conditions:

Open-Angle Glaucoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hyper...

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hyper...

Eligibility Criteria

Inclusion

  • Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
  • Subject on at least one glaucoma medication
  • Able and willing to attend follow up visits for two years post operative
  • Able and willing to sign informed consent

Exclusion

  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Angle closure glaucoma
  • Fellow eye already enrolled

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00323284

Start Date

June 1 2005

End Date

March 1 2010

Last Update

January 12 2018

Active Locations (31)

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Page 1 of 8 (31 locations)

1

Assil Eye Institute

Beverly Hills, California, United States, 90210

2

North Bay Eye Associates Inc

Petaluma, California, United States, 94954

3

Ellison Ambulatory Care Center

Sacramento, California, United States, 95817

4

Harvard Eye Associates

San Clemente, California, United States, 92673