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One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517477
First Posted: January 25, 2012
Last Update Posted: March 25, 2016
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 intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

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 intraocular pressure (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 ]

Enrollment: 251
Study Start Date: January 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Arm: One iStent
Device: One iStent
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Experimental: Second Arm: Two iStents
Device: Two iStent devices
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Experimental: Third Arm: Three iStents
Device: Three iStent devices
Device: iStent
Implantation of Three iStents through a small temporal 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): NCT01517477


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: NCT01517477     History of Changes
Other Study ID Numbers: GCF-033
First Submitted: January 23, 2012
First Posted: January 25, 2012
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 18 month results published in Clinical Ophthalmology 2015:9 2313-2320.

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