A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma (SY)

May 18, 2015 updated by: Glaukos Corporation
Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Study Type

Interventional

Enrollment (Actual)

112

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 Ophtalmology Centre
  • Austria
      • Wien, Austria, 1090
        • Allgemeines Krankenhaus Wien
  • France
      • Lyon, France, 69437
        • Chu de Lyon Hospital Edouard Herriot
      • Paris, France, 75012
        • CHNO des Quinze-Vingts
      • Paris, France, 75014
        • Hôpital Saint-Joseph
  • Germany
      • Bochum, Germany, 44892
        • Knapschaftskrankenhaus Bochum Langendreer
      • Erlangen, Germany
        • Universitatsklinkum Erlangen
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R.
      • Neubrandenburg, Germany, 17036
        • Dietrich-Bonhoeffer-Klinikum Neubrandenburg
  • Italy
      • Parma, Italy, 43100
        • Universita' degli Studi di Parma
      • Torino, Italy, 10128
        • Universita'di Torino
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Torrevieja, Spain, 03186
        • Hospital Torrevieja Salud, UTE

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:

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

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: iStent
Device: iStent
Glaukos iStent, medication
Other Names:
  • stent, trabecular micro-bypass stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP 18 mm Hg or less without medications
Time Frame: At 6 months
At 6 months
IOP 18 mm Hg or less with or without medications
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean IOP
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

May 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Synergy
  • Synergy Trial

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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