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

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. Identifier: NCT01252862
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Subjects With Primary Open-angle Glaucoma (POAG) Device: iStent Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Actual Study Start Date : December 2010
Primary Completion Date : July 2016
Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Two iStents devices
Two iStents devices will be implanted
Device: iStent
Implantation of two iStents through a small temporal clear corneal incision

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

Secondary Outcome Measures :
  1. IOP < 18 mm Hg at Month 12 [ Time Frame: 12 months ]

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

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

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 identifier (NCT number): NCT01252862

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

Responsible Party: Glaukos Corporation Identifier: NCT01252862     History of Changes
Other Study ID Numbers: GCF-017
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

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

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