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A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

NCT00326066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-03-09

No results posted yet for this study

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 newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Conditions

  • Open-Angle Glaucoma

Interventions

DEVICE

Glaucoma Surgery

Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.

PROCEDURE

cataract surgery only

Subjects will undergo routine cataract surgery only (no stent implant).

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Head of Clinical Affairs · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Austria
  • Germany
  • Netherlands
  • Spain
  • Turkey (Türkiye)

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 NCT00326066 on ClinicalTrials.gov