A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
NCT ID: NCT00911924
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
112 participants
INTERVENTIONAL
2009-05-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iStent
iStent
Glaukos iStent, medication
Interventions
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iStent
Glaukos iStent, medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Secondary glaucomas
* Prior glaucoma procedures
* Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
18 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Wells, PharmD, MBA
Role: STUDY_DIRECTOR
Glaukos Corporation
Locations
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S.V. Malayan's Ophtalmology Centre
Yerevan, , Armenia
Allgemeines Krankenhaus Wien
Vienna, , Austria
Chu de Lyon Hospital Edouard Herriot
Lyon, , France
CHNO des Quinze-Vingts
Paris, , France
Hopital Saint-Joseph
Paris, , France
Knapschaftskrankenhaus Bochum Langendreer
Bochum, , Germany
Universitatsklinkum Erlangen
Erlangen, , Germany
Universitatsklinikum Magdeburg A.o.R.
Magdeburg, , Germany
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
Neubrandenburg, , Germany
Universita' degli Studi di Parma
Parma, , Italy
Universita'di Torino
Torino, , Italy
Hospital clinico San Carlos
Madrid, , Spain
Hospital Torrevieja Salud, UTE
Torrevieja, , Spain
Countries
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References
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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.
Other Identifiers
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Synergy Trial
Identifier Type: -
Identifier Source: secondary_id
Synergy
Identifier Type: -
Identifier Source: org_study_id
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