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Clinical Trials/NCT00911924
NCT00911924CompletedPhase 4

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

Glaukos Corporation13 sites in 6 countries112 target enrollmentStarted: May 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
112
Locations
13
Primary Endpoint
IOP 18 mm Hg or less with or without medications
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

iStent

Experimental

Intervention: iStent (Device)

Outcomes

Primary Outcomes

IOP 18 mm Hg or less with or without medications

Time Frame: 12 months

IOP 18 mm Hg or less without medications

Time Frame: At 6 months

Secondary Outcomes

  • Mean IOP(12 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (13)

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