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Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Glaukos Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01252849
First Posted: December 3, 2010
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Glaukos Corporation
  Purpose
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Condition Intervention Phase
Primary Open Angle Glaucoma (POAG) Device: iStent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline [ Time Frame: 12 Months ]

Secondary Outcome Measures:
  • Mean diurnal IOP <18 mmHg at month 12 [ Time Frame: 12 months ]

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Arm: One iStent, medication
Device: One iStent, medication
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Experimental: Second Arm: Two iStents, medication
Device: Two iStent devices, medication
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Experimental: Third Arm: Three iStents, medication
Device: Three iStent devices, medication
Device: iStent
Implantation of Three iStents through a small temperal clear corneal incision

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on two topical hypotensive medications

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252849


Locations
Armenia
S.V. Malayan's Ophthalmology Centre
Yerevan, Armenia, 375108
Sponsors and Collaborators
Glaukos Corporation
  More Information

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252849     History of Changes
Other Study ID Numbers: GCF-016
First Submitted: December 1, 2010
First Posted: December 3, 2010
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
surgery
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases