NCT00326079

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 subjects with open-angle glaucoma.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_4

Geographic Reach
4 countries

7 active sites

Status
unknown

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

August 1, 2004

Completed
1.8 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
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

8.8 years

First QC Date

May 12, 2006

Last Update Submit

March 28, 2013

Conditions

Open-Angle Glaucoma

Keywords

Open angleGlaucomaSurgery

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    24 months

Study Arms (2)

1

ACTIVE COMPARATOR
Device: Stent

2

ACTIVE COMPARATOR
Device: Stent

Interventions

StentDEVICE

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Also known as: iStent
12

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with open-angle glaucoma (OAG)
  • Subject on at least one glaucoma medication
  • Signed informed consent

You may not qualify if:

  • Angle closure glaucoma
  • Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Fellow eye already enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Vienna Medical University

Vienna, A-1090, Austria

Location

Klinik Vincentinum

Augsburg, 86150, Germany

Location

Mainz University

Mainz, Germany

Location

Private Practice

Weinheim, D-69469, Germany

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Instituto Oftalmológico de Aragón

Zaragoza, 50007, Spain

Location

Beyoglu Eye Research and Education Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

Stents

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Head of Clinical Affairs

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

August 1, 2004

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

ES(2)DE(3)AU(1)TU(1)