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A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

NCT00323284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-01-12

Study results available
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Summary

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 subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Conditions

  • Open-Angle Glaucoma

Interventions

DEVICE

iStent plus Cataract Surgery

ab interno trabecular bypass stent surgery

PROCEDURE

Cataract surgery only

Cataract surgery only

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Jeff Wells, PharmD, MBA · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-07-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323284 on ClinicalTrials.gov