Recruiting

Hydrus® Microstent

Sponsor:

Alcon Research

Code:

NCT04553523

Conditions

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Hydrus Microstent

Cataract surgery

Monofocal IOL

Study Details

Brief 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.

Conditions

Primary Open Angle Glaucoma

Study ID

NCT04553523

Start date

Aug 25, 2020

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

545 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydrus Microstent

Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)

Interventions

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.

Cataract surgery

Cataract surgery performed using standard anesthesia and phacoemulsification techniques

Monofocal IOL

Commercially available monofocal intraocular lens as determined by the investigator

Primary outcome measure

  • Rate of occurrence of clinically significant device malposition associated with clinical sequelae [ Time Frame: Day 0 operative, up to Month 24 postoperative ]

Central Contacts and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

Sacramento Eye Consultants

Recruiting

Sacramento, California, United States, 95815

Eye Center of Northern Colorado

Recruiting

Loveland, Colorado, United States, 80538

Jones Eye Center PC

Recruiting

Sioux City, Iowa, United States, 51104

Fraser Eye Care Center

Recruiting

Fraser, Michigan, United States, 48026

Twin Cities Eye Consultants

Recruiting

Coon Rapids, Minnesota, United States, 55433

Midwest Vision Research Foundation

Recruiting

Chesterfield, Missouri, United States, 63017

Center for Sight

Recruiting

Las Vegas, Nevada, United States, 89145

Carolina Eye Associates PA

Recruiting

Southern Pines, North Carolina, United States, 28387

Cincinnati Eye Institute

Recruiting

Cincinnati, Ohio, United States, 45242

Texan Eye / Keystone Research

Recruiting

Austin, Texas, United States, 78731

El Paso Eye Surgeons

Recruiting

El Paso, Texas, United States, 79902

Texas Eye Research Center

Recruiting

Hurst, Texas, United States, 76054

Eye Centers Of Racine And Kenosha

Recruiting

Kenosha, Wisconsin, United States, 53142

More Information

Sponsor

Alcon Research

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alcon Research on 2026-07-14.