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

August 29, 2022 updated by: Glaukos Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia, 375108
        • S.V. Malayan's Ophthalmology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Device: iStent
Implantation of Three iStents through a small temperal clear corneal incision
Experimental: Second Arm: Two iStents, medication
Device: Two iStent devices, medication
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Device: iStent
Implantation of Three iStents through a small temperal clear corneal incision
Experimental: Third Arm: Three iStents, medication
Device: Three iStent devices, medication
Device: iStent
Implantation of One iStent through a small temporal clear corneal incision.
Device: iStent
Implantation of Two iStents through a small temporal clear corneal incision
Device: iStent
Implantation of Three iStents through a small temperal clear corneal incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean diurnal IOP <18 mmHg at month 12
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

October 8, 2019

Study Completion (Actual)

October 8, 2019

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCF-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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