Recruiting

Hydrus® Microstent New Enrollment Post-Approval Study

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.

ClinicalTrials.gov IDNCT04553523

PhaseNA

Enrollment545

SponsorAlcon Research

Age45 Years

SexALL

I'm interested View official listing

Conditions studied

Primary Open Angle Glaucoma

About this study

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

Primary outcomes

Rate of occurrence of clinically significant device malposition associated with clinical sequelae (Day 0 operative, up to Month 24 postoperative)

Eligibility information

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 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

Showing 10 of 22 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.