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Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

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: NCT01252849
Recruitment Status : Active, not recruiting
First Posted : December 3, 2010
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma (POAG) Device: iStent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: iStent 1, 2, or 3 stents
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Study Start Date : December 2010
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: First Arm: One iStent, medication
Device: One iStent, medication
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.

Experimental: Second Arm: Two iStents, medication
Device: Two iStent devices, medication
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision

Experimental: Third Arm: Three iStents, medication
Device: Three iStent devices, medication
Device: iStent
Implantation of Three iStents through a small temperal 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. Mean diurnal IOP <18 mmHg 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 two topical hypotensive medications

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): NCT01252849


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

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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01252849     History of Changes
Other Study ID Numbers: GCF-016
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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

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