Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
NCT04553523

Hydrus® Microstent New Enrollment Post-Approval Study

Led by Alcon Research · Updated on 2025-06-03

545

Participants Needed

22

Research Sites

405 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hydrus® Microstent New Enrollment Post-Approval Study

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 intraocular pressure less than or equal to 31 millimeters mercury (mmHg)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Coastal Vision

Irvine, California, United States, 92618

Completed

2

Sacramento Eye Consultants

Sacramento, California, United States, 95815

Actively Recruiting

3

Eye Center of Northern Colorado

Loveland, Colorado, United States, 80538

Actively Recruiting

4

Jones Eye Center PC

Sioux City, Iowa, United States, 51104

Actively Recruiting

5

Stiles Eyecare Excellence Cataracts and Glaucoma

Overland Park, Kansas, United States, 66213

Not Yet Recruiting

6

Visionary Eye Doctors

Rockville, Maryland, United States, 20852

Not Yet Recruiting

7

Fraser Eye Care Center

Fraser, Michigan, United States, 48026

Actively Recruiting

8

Twin Cities Eye Consultants

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

9

Midwest Vision Research Foundation

Chesterfield, Missouri, United States, 63017

Actively Recruiting

10

Moyes Eye Center

Kansas City, Missouri, United States, 64154

Not Yet Recruiting

11

Center for Sight

Las Vegas, Nevada, United States, 89145

Actively Recruiting

12

Carolina Eye Associates PA

Southern Pines, North Carolina, United States, 28387

Actively Recruiting

13

Cleveland Eye Clinic

Brecksville, Ohio, United States, 44141

Completed

14

Cincinnati Eye Institute

Cincinnati, Ohio, United States, 45242

Actively Recruiting

15

Cincinnati Eye / Apex Eye

Mason, Ohio, United States, 45040

Not Yet Recruiting

16

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States, 16066

Not Yet Recruiting

17

Texan Eye / Keystone Research

Austin, Texas, United States, 78731

Actively Recruiting

18

Glaucoma Associates Of Texas

Dallas, Texas, United States, 75231

Not Yet Recruiting

19

El Paso Eye Surgeons

El Paso, Texas, United States, 79902

Actively Recruiting

20

Texas Eye Research Center

Hurst, Texas, United States, 76054

Actively Recruiting

21

The Eye Institute of Utah

Salt Lake City, Utah, United States, 84107

Not Yet Recruiting

22

Eye Centers Of Racine And Kenosha

Kenosha, Wisconsin, United States, 53142

Actively Recruiting

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Research Team

A

Alcon Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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