Hydrus® Microstent New Enrollment Post-Approval Study

Last updated: May 28, 2024
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Open Angle Glaucoma

Treatment

Monofocal IOL

Cataract surgery

Hydrus Microstent

Clinical Study ID

NCT04553523
CP 18-001
GLI314-C003
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40or worse;

  • Diagnosis of primary open angle glaucoma treated with no more than 4 topicalhypotensive medications;

  • Optic nerve appearance characteristic of glaucoma;

  • Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Otherprotocol-defined inclusion criteria may apply.

Exclusion

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 otherprior filtration or cilioablative surgery;

  • Prior surgery with implanted device or other surgery involving the trabecularmeshwork or Schlemm's canal;

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 545
Treatment Group(s): 3
Primary Treatment: Monofocal IOL
Phase:
Study Start date:
August 25, 2020
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Coastal Vision

    Irvine, California 92618
    United States

    Completed

  • Coastal Vision

    Orange, California 92868
    United States

    Site Not Available

  • Alcon Investigator 7977

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Sacramento Eye Consultants

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Eye Center of Northern Colorado

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Alcon Investigator 4421

    Loveland, Colorado 80538
    United States

    Site Not Available

  • Eye Center of Northern Colorado

    Loveland, Colorado 80538
    United States

    Active - Recruiting

  • Alcon Investigator 6183

    Sioux City, Iowa 51104
    United States

    Active - Recruiting

  • Jones Eye Center PC

    Sioux City, Iowa 51104
    United States

    Active - Recruiting

  • Stiles Eyecare Excellence Cataracts and Glaucoma

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Visionary Eye Doctors

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Alcon Investigator 7931

    Fraser, Michigan 48026
    United States

    Active - Recruiting

  • Fraser Eye Care Center

    Fraser, Michigan 48026
    United States

    Active - Recruiting

  • Alcon Investigator 8210

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Twin Cities Eye Consultants

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Alcon Investigator 8208

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Midwest Vision Research Foundation

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Moyes Eye Center

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • Alcon Investigator 8209

    Las Vegas, Nevada 89145
    United States

    Active - Recruiting

  • Center for Sight

    Las Vegas, Nevada 89145
    United States

    Active - Recruiting

  • Alcon Investigator 8211

    Southern Pines, North Carolina 28387
    United States

    Active - Recruiting

  • Carolina Eye Associates PA

    Southern Pines, North Carolina 28387
    United States

    Active - Recruiting

  • Cleveland Eye Clinic

    Brecksville, Ohio 44141
    United States

    Completed

  • Alcon Investigator 6725

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cincinnati Eye / Apex Eye

    Mason, Ohio 45040
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Alcon Investigator 5182

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Texan Eye / Keystone Research

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Glaucoma Associates Of Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Alcon Investigator 5231

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • El Paso Eye Surgeons

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Alcon Investigator 6185

    Hurst, Texas 76054
    United States

    Active - Recruiting

  • Texas Eye Research Center

    Hurst, Texas 76054
    United States

    Active - Recruiting

  • The Eye Institute of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Alcon Investigator 5471

    Kenosha, Wisconsin 53142
    United States

    Active - Recruiting

  • Eye Centers Of Racine And Kenosha

    Kenosha, Wisconsin 53142
    United States

    Active - Recruiting

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