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Clinical Trials/NCT00911924
NCT00911924
Completed
Phase 4

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

Glaukos Corporation13 sites in 6 countries112 target enrollmentMay 2009
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ConditionsGlaucomaEye DiseasesGlaucoma, Open-Angle

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Glaukos Corporation
Enrollment
112
Locations
13
Primary Endpoint
IOP 18 mm Hg or less with or without medications
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
September 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (13)

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