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RECRUITING
NCT04553523
NA

Hydrus® Microstent New Enrollment Post-Approval Study

Sponsor: Alcon Research

View on ClinicalTrials.gov

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.

Official title: The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

545

Start Date

2020-08-25

Completion Date

2028-06

Last Updated

2025-06-03

Healthy Volunteers

No

Interventions

DEVICE

Hydrus Microstent

Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.

PROCEDURE

Cataract surgery

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

DEVICE

Monofocal IOL

Commercially available monofocal intraocular lens as determined by the investigator

Locations (22)

Coastal Vision

Irvine, California, United States

Sacramento Eye Consultants

Sacramento, California, United States

Eye Center of Northern Colorado

Loveland, Colorado, United States

Jones Eye Center PC

Sioux City, Iowa, United States

Stiles Eyecare Excellence Cataracts and Glaucoma

Overland Park, Kansas, United States

Visionary Eye Doctors

Rockville, Maryland, United States

Fraser Eye Care Center

Fraser, Michigan, United States

Twin Cities Eye Consultants

Coon Rapids, Minnesota, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Moyes Eye Center

Kansas City, Missouri, United States

Center for Sight

Las Vegas, Nevada, United States

Carolina Eye Associates PA

Southern Pines, North Carolina, United States

Cleveland Eye Clinic

Brecksville, Ohio, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Cincinnati Eye / Apex Eye

Mason, Ohio, United States

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Texan Eye / Keystone Research

Austin, Texas, United States

Glaucoma Associates Of Texas

Dallas, Texas, United States

El Paso Eye Surgeons

El Paso, Texas, United States

Texas Eye Research Center

Hurst, Texas, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

Eye Centers Of Racine And Kenosha

Kenosha, Wisconsin, United States