NCT00326066

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 newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
5 countries

9 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

February 1, 2005

Completed
1.3 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 9, 2018

Status Verified

March 1, 2018

Enrollment Period

8.2 years

First QC Date

May 12, 2006

Last Update Submit

March 7, 2018

Conditions

Open-Angle Glaucoma

Keywords

Open angleGlaucomaSurgeryCataract

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    24 months

Study Arms (2)

1

ACTIVE COMPARATOR
Device: Glaucoma Surgery

2

PLACEBO COMPARATOR
Procedure: cataract surgery only

Interventions

Glaucoma SurgeryDEVICE

Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.

Also known as: two Glaukos iStent Trabecular Bypass Microstents
1
cataract surgery onlyPROCEDURE

Subjects will undergo routine cataract surgery only (no stent implant).

Also known as: Phacoemulsification
2

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
  • All subjects must need cataract surgery.

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 (9)

Vienna Medical Hospital

Vienna, A-1090, Austria

Location

Mainz University

Mainz, Germany

Location

Augenklinik der Technischen Universitat

Munich, 81675, Germany

Location

Universitats- Augenklinik

Würzburg, D-97080, Germany

Location

The Netherlands Ophthalmic Research Institute

Amsterdam, Netherlands

Location

Ophthalmic Clinic

Rotterdam, Netherlands

Location

Clinico San Carlos

Madrid, 28040, Spain

Location

Instituto Oftalmológico de Aragón

Zaragoza, 50007, Spain

Location

Beyoglu Eye Research and Education Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.

    PMID: 20207977DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucomaCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Head of Clinical Affairs

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
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

February 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

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