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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00911924
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Glaukos Corporation

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.

Condition or disease Intervention/treatment Phase
Glaucoma Eye Diseases Glaucoma, Open-Angle Device: iStent Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Study Start Date : May 2009
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: iStent Device: iStent
Glaukos iStent, medication
Other Name: stent, trabecular micro-bypass stent

Primary Outcome Measures :
  1. IOP 18 mm Hg or less without medications [ Time Frame: At 6 months ]
  2. IOP 18 mm Hg or less with or without medications [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean IOP [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911924

S.V. Malayan's Ophtalmology Centre
Yerevan, Armenia, 375108
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Chu de Lyon Hospital Edouard Herriot
Lyon, France, 69437
CHNO des Quinze-Vingts
Paris, France, 75012
Hopital Saint-Joseph
Paris, France, 75014
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
Universita' degli Studi di Parma
Parma, Italy, 43100
Universita'di Torino
Torino, Italy, 10128
Hospital clinico San Carlos
Madrid, Spain, 28040
Hospital Torrevieja Salud, UTE
Torrevieja, Spain, 03186
Sponsors and Collaborators
Glaukos Corporation
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00911924     History of Changes
Other Study ID Numbers: Synergy
Synergy Trial
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

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

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