Hydrus® Microstent New Enrollment Post-Approval Study

Recruiting now · Not applicable

Conditions studied: Primary Open Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT04553523

Run by

Alcon Research

People needed

545

Starts

2020-08-25

Expected to finish

2028-08-01

Last updated by the study team

2026-07-14

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eye Centers Of Racine And Kenosha — Kenosha, Wisconsin, United States (enrolling)
• Sacramento Eye Consultants — Sacramento, California, United States (enrolling)
• Eye Center of Northern Colorado — Loveland, Colorado, United States (enrolling)
• Jones Eye Center PC — Sioux City, Iowa, United States (enrolling)
• Fraser Eye Care Center — Fraser, Michigan, United States (enrolling)
• Twin Cities Eye Consultants — Coon Rapids, Minnesota, United States (enrolling)
• Midwest Vision Research Foundation — Chesterfield, Missouri, United States (enrolling)
• Center for Sight — Las Vegas, Nevada, United States (enrolling)
• Carolina Eye Associates PA — Southern Pines, North Carolina, United States (enrolling)
• Cincinnati Eye Institute — Cincinnati, Ohio, United States (enrolling)
• Texan Eye / Keystone Research — Austin, Texas, United States (enrolling)
• El Paso Eye Surgeons — El Paso, Texas, United States (enrolling)
• Texas Eye Research Center — Hurst, Texas, United States (enrolling)
• Stiles Eyecare Excellence Cataracts and Glaucoma — Overland Park, Kansas, United States
• Visionary Eye Doctors — Rockville, Maryland, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States
• Cincinnati Eye / Apex Eye — Mason, Ohio, United States
• Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Coastal Vision — Irvine, California, United States
• Glaucoma Associates Of Texas — Dallas, Texas, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

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