A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

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Glaukos

Status and phase

Completed
Phase 4

Conditions

Open-Angle Glaucoma

Treatments

Device: Glaucoma Surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT00326040
GC-001A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Full description

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
  • Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion criteria

  • Angle closure glaucoma
  • Fellow eye already enrolled

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

A
Experimental group
Treatment:
Device: Glaucoma Surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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