NCT00911924

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2009

Longer than P75 for phase_4

Geographic Reach
6 countries

13 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

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

4.3 years

First QC Date

June 1, 2009

Last Update Submit

May 18, 2015

Conditions

GlaucomaEye DiseasesGlaucoma, Open-Angle

Keywords

primary open angle glaucoma (POAG)OAGglaucoma

Outcome Measures

Primary Outcomes (2)

  • IOP 18 mm Hg or less without medications

    At 6 months

  • IOP 18 mm Hg or less with or without medications

    12 months

Secondary Outcomes (1)

  • Mean IOP

    12 months

Study Arms (1)

iStent

EXPERIMENTAL
Device: iStent

Interventions

iStentDEVICE

Glaukos iStent, medication

Also known as: stent, trabecular micro-bypass stent
iStent

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

S.V. Malayan's Ophtalmology Centre

Yerevan, 375108, Armenia

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Chu de Lyon Hospital Edouard Herriot

Lyon, 69437, France

Location

CHNO des Quinze-Vingts

Paris, 75012, France

Location

Hopital Saint-Joseph

Paris, 75014, France

Location

Knapschaftskrankenhaus Bochum Langendreer

Bochum, 44892, Germany

Location

Universitatsklinkum Erlangen

Erlangen, Germany

Location

Universitatsklinikum Magdeburg A.o.R.

Magdeburg, 39120, Germany

Location

Dietrich-Bonhoeffer-Klinikum Neubrandenburg

Neubrandenburg, 17036, Germany

Location

Universita' degli Studi di Parma

Parma, 43100, Italy

Location

Universita'di Torino

Torino, 10128, Italy

Location

Hospital clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Torrevieja Salud, UTE

Torrevieja, 03186, Spain

Location

Related Publications (1)

  • Voskanyan L, Garcia-Feijoo J, Belda JI, Fea A, Junemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent(R) inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-0095-y. Epub 2014 Jan 23.

    PMID: 24452726RESULT

MeSH Terms

Conditions

GlaucomaEye DiseasesGlaucoma, Open-Angle

Interventions

Stents

Condition Hierarchy (Ancestors)

Ocular Hypertension

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Jeff Wells, PharmD, MBA

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

ES(2)AU(1)AR(1)IT(2)FR(3)DE(4)