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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Glaukos Corporation Identifier:
First received: December 1, 2010
Last updated: May 18, 2015
Last verified: May 2015
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two 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:
  • Mean diurnal IOP < 18 mmHg at month 12 [ Time Frame: 12 months ]

Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two iStent devices and medication
Implantation of two iStents through small temporal clear corneal incision
Device: iStents
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.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled
  Contacts and Locations
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Please refer to this study by its identifier: NCT01252888

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

Responsible Party: Glaukos Corporation Identifier: NCT01252888     History of Changes
Other Study ID Numbers: GCF-018
Study First Received: December 1, 2010
Last Updated: May 18, 2015

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents processed this record on April 26, 2017