Back to Trials
NCT04553523NARecruiting

Hydrus® Microstent New Enrollment Post-Approval Study

Alcon Research

Start Date

8/25/2020

Completion Date

8/1/2028

Summary

The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Detailed Description

Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

Eligibility Criteria

Age Range: 45 years to No maximum

Inclusion Criteria: * An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse; * Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications; * Optic nerve appearance characteristic of glaucoma; * Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Closed angle forms of glaucoma; * Congenital or developmental glaucoma; * Secondary glaucoma; * Use of more than 4 ocular hypotensive medications; * Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery; * Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal; * Other protocol-defined exclusion criteria may apply.

Interventions

DEVICE

Hydrus Microstent

PROCEDURE

Cataract surgery

DEVICE

Monofocal IOL

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Primary Open Angle Glaucoma

Locations

Coastal Vision

Irvine, California 92618

United States

Sacramento Eye Consultants

Sacramento, California 95815

United States

Eye Center of Northern Colorado

Loveland, Colorado 80538

United States

Jones Eye Center PC

Sioux City, Iowa 51104

United States

Stiles Eyecare Excellence Cataracts and Glaucoma

Overland Park, Kansas 66213

United States

Visionary Eye Doctors

Rockville, Maryland 20852

United States

Fraser Eye Care Center

Fraser, Michigan 48026

United States

Twin Cities Eye Consultants

Coon Rapids, Minnesota 55433

United States

Midwest Vision Research Foundation

Chesterfield, Missouri 63017

United States

Moyes Eye Center

Kansas City, Missouri 64154

United States

Center for Sight

Las Vegas, Nevada 89145

United States

Carolina Eye Associates PA

Southern Pines, North Carolina 28387

United States

Cleveland Eye Clinic

Brecksville, Ohio 44141

United States

Cincinnati Eye Institute

Cincinnati, Ohio 45242

United States

Cincinnati Eye / Apex Eye

Mason, Ohio 45040

United States

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania 16066

United States

Texan Eye / Keystone Research

Austin, Texas 78731

United States

Glaucoma Associates Of Texas

Dallas, Texas 75231

United States

El Paso Eye Surgeons

El Paso, Texas 79902

United States

Texas Eye Research Center

Hurst, Texas 76054

United States

The Eye Institute of Utah

Salt Lake City, Utah 84107

United States

Eye Centers Of Racine And Kenosha

Kenosha, Wisconsin 53142

United States