Tests Hydrus Microstent with cataract surgery in glaucoma patients
Studies the Hydrus Microstent placed during cataract surgery in adults with glaucoma.
Plain-language title generated from the registry record
Registry title: Hydrus® Microstent New Enrollment Post-Approval Study
Key facts
- Where
- Austin, Brecksville, Chesterfield, Cincinnati, Coon Rapids, Cranberry Township, Dallas, El Paso, Fraser, Hurst, Irvine, Kansas City, Kenosha, Las Vegas, Loveland, Mason, Overland Park, Rockville, Sacramento, Salt Lake City, Sioux City, and Southern Pines, United StatesSee the 22 sites
Where in United States
- Texan Eye / Keystone ResearchAustin, United StatesTaking people
- Cleveland Eye ClinicBrecksville, United StatesNo longer taking part
- Midwest Vision Research FoundationChesterfield, United StatesTaking people
- Cincinnati Eye InstituteCincinnati, United StatesTaking people
- Twin Cities Eye ConsultantsCoon Rapids, United StatesTaking people
- Scott & Christie and Associates, PCCranberry Township, United StatesNot yet recruiting
- Glaucoma Associates of TexasDallas, United StatesNot yet recruiting
- El Paso Eye SurgeonsEl Paso, United StatesTaking people
- Fraser Eye Care CenterFraser, United StatesTaking people
- Texas Eye Research CenterHurst, United StatesTaking people
- Coastal VisionIrvine, United StatesNo longer taking part
- Moyes Eye CenterKansas City, United StatesNot yet recruiting
- Eye Centers of Racine and KenoshaKenosha, United StatesTaking people
- Center for SightLas Vegas, United StatesTaking people
- Eye Center of Northern ColoradoLoveland, United StatesTaking people
- Cincinnati Eye / Apex EyeMason, United StatesNot yet recruiting
- Stiles Eyecare Excellence Cataracts and GlaucomaOverland Park, United StatesNot yet recruiting
- Visionary Eye DoctorsRockville, United StatesNot yet recruiting
- Sacramento Eye ConsultantsSacramento, United StatesTaking people
- The Eye Institute of UtahSalt Lake City, United StatesNot yet recruiting
- Jones Eye Center PCSioux City, United StatesTaking people
- Carolina Eye Associates PASouthern Pines, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alcon Research
- Trial code
- NCT04553523
- Record updated
- 22 September 2026
- Original description
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.Read full original descriptionShow less
The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
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.
Inclusion: 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: 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; Closed angle forms of glaucoma; Congenital or developmental glaucoma; Secondary glaucoma; Other protocol-defined exclusion criteria may apply.