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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00911924
First received: June 1, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Device: iStent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Mean intraocular pressure (IOP) [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iStent Device: iStent
Glaukos iStent, medication
Other Name: stent, trabecular micro-bypass stent

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911924

Locations
Armenia
S.V. Malayan's Ophtalmology Centre
Yerevan, Armenia, 375108
Austria
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
France
Chu de Lyon Hospital Edouard Herriot
Lyon, France, 69437
CHNO des Quinze-Vingts
Paris, France, 75012
Hopital Saint-Joseph
Paris, France, 75014
Germany
Knapschaftskrankenhaus Bochum Langendreer
Bochum, Germany, 44892
Universitatsklinkum Erlangen
Erlangen, Germany
Universitatsklinikum Magdeburg A.o.R.
Magdeburg, Germany, 39120
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
Neubrandenburg, Germany, 17036
Italy
Universita' degli Studi di Parma
Parma, Italy, 43100
Universita'di Torino
Torino, Italy, 10128
Spain
Hospital clinico San Carlos
Madrid, Spain, 28040
Hospital Torrevieja Salud, UTE
Torrevieja, Spain, 03186
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
  More Information

No publications provided by Glaukos Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00911924     History of Changes
Other Study ID Numbers: Synergy, Synergy Trial
Study First Received: June 1, 2009
Last Updated: March 28, 2013
Health Authority: Italy: Ethics Committee
Greece: Ethics Committee
Austria: Ethikkommission
Germany: Ethics Commission
Spain: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Glaukos Corporation:
primary open angle glaucoma (POAG)
OAG
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 16, 2014