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COMPLETEDPHASE3

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

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

NCT00323284•Glaukos Corporation

View on ClinicalTrials.gov

Summary

Detailed Description

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. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
•Subject on at least one glaucoma medication
•Able and willing to attend follow up visits for two years post operative
•Able and willing to sign informed consent

Exclusion Criteria

•Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
•Angle closure glaucoma
•Fellow eye already enrolled

Locations (31)

Assil Eye Institute

Beverly Hills, California, United States

North Bay Eye Associates Inc

Petaluma, California, United States

Ellison Ambulatory Care Center

Sacramento, California, United States

Harvard Eye Associates

San Clemente, California, United States

Shepard Eye Center

Santa Maria, California, United States

Glaucoma Consultants of Colorado

Littleton, Colorado, United States

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, United States

The Center for Excellence in Eye Care

Miami, Florida, United States

International Eye Center

Tampa, Florida, United States

Clayton Eye Center

Morrow, Georgia, United States

Key Dates

Start Date

June 1, 2005

Primary Completion Date

July 1, 2009

Completion Date

March 1, 2010

Last Updated

January 12, 2018

Enrollment

240

ACTUAL participants

Conditions

Open-Angle Glaucoma

Interventions

iStent plus Cataract Surgery

DEVICE

Cataract surgery only

PROCEDURE

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

NCT06267274

Open-angle GlaucomaOcular Hypertension

View study

COMPLETEDPHASE3

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

NCT03850782

Open-Angle GlaucomaOcular Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

PASCAL Trabeculoplasty

PRESERFLO® MicroShunt Extension Study

Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity

Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost