NCT00326040

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 25, 2008

Status Verified

July 1, 2008

First QC Date

May 12, 2006

Last Update Submit

July 23, 2008

Conditions

Open-Angle Glaucoma

Keywords

Open angleGlaucomaRefractorySurgery

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    24 months

Study Arms (1)

A

EXPERIMENTAL
Device: Glaucoma Surgery

Interventions

Glaucoma SurgeryDEVICE
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
  • Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

You may not qualify if:

  • Angle closure glaucoma
  • Fellow eye already enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Cologne

Cologne, 50931, Germany

Location

Klinik für Augenheilkunde

Neubradenbrug, 17033, Germany

Location

University Eye Clinic

Genova, 16132, Italy

Location

Instituto di Oftalmologia

Parma, 43100, Italy

Location

Ophthalmic Clinic

Rotterdam, Netherlands

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Instituo Oftalmologico de Aragon

Zaragoza, 5007, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Head of Clinical Affairs

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

April 1, 2003

Study Completion

August 1, 2007

Last Updated

July 25, 2008

Record last verified: 2008-07

Locations

IT(2)ES(2)DE(2)NL(1)