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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.
 
ClinicalTrials.gov Identifier: NCT01252862
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 18, 2017
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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, Older Adult)
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

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
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Armenia
S.V. Malayan's Ophthalmology Centre
Yerevan, Armenia, 375108
Sponsors and Collaborators
Glaukos Corporation
Publications:
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252862    
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
Glaucoma
Surgery
Ocular Hypertension
eye diseases
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases