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

December 14, 2017 updated by: Glaukos Corporation

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

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

Yes

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

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
IOP < 18 mm Hg 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2016

Study Completion (Actual)

December 1, 2016

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)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCF-017

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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