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Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

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:
NCT01252862
First Posted: December 3, 2010
Last Update Posted: May 20, 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 intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Condition Intervention Phase
Subjects With Primary Open-angle Glaucoma (POAG) Device: iStent Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two 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:
  • IOP < 18 mm Hg at Month 12 [ Time Frame: 12 months ]

Estimated Enrollment: 40
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: Two iStents devices
Two iStents devices will be implanted
Device: iStent
Implantation of two iStents through a small temporal clear corneal incision

Detailed Description:
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects
  Eligibility

Information from the National Library of Medicine

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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 one topical hypotensive medication

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): NCT01252862


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: NCT01252862     History of Changes
Other Study ID Numbers: GCF-017
First Submitted: December 1, 2010
First Posted: December 3, 2010
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery
Ocular Hypertension
eye diseases

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


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