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

This study has been completed.
Information provided by (Responsible Party):
Glaukos Corporation Identifier:
First received: June 1, 2009
Last updated: May 18, 2015
Last verified: May 2015
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: 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

Resource links provided by NLM:

Further study details as provided by Glaukos Corporation:

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

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

Enrollment: 112
Study Start Date: May 2009
Study Completion Date: September 2013
Primary Completion Date: September 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.

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
  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 identifier: 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
  More Information

Responsible Party: Glaukos Corporation Identifier: NCT00911924     History of Changes
Other Study ID Numbers: Synergy
Synergy Trial
Study First Received: June 1, 2009
Last Updated: May 18, 2015

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension processed this record on September 21, 2017