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COMPLETEDPhase 4NCT00913029

Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Lead sponsor: Glaukos Corporation•16 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Glaukos Corporation

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

Age

18 - No limit years

Sex

ALL

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 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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 20, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment192

Start dateMay 2009

Last updatedMay 20, 2015

Condition

Eye Diseases Glaucoma, Open-Angle Glaucoma

Locations shown

SV Malayan Ophthalmological Center

Yerevan

Allgemeines Krankenhaus Wien

Vienna

CHU de Lyon Hopital Edouard Herriot

Lyon

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2015Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions