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

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ClinicalTrials.gov Identifier: NCT01252888
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

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 Two 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


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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. Mean diurnal IOP < 18 mmHg at month 12 [ Time Frame: 12 months ]

Eligibility Criteria

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)
  • Subjects 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): NCT01252888


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