Hydrus® Microstent New Enrollment Post-Approval Study

Part of paid clinical trials in Irvine, California.

Sponsor
Alcon Research
Study ID
NCT04553523
Status
Recruiting
Apply to this trial

Conditions

  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydrus Microstent — DEVICE
    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 — PROCEDURE
    Cataract surgery performed using standard anesthesia and phacoemulsification techniques
  • Monofocal IOL — DEVICE
    Commercially available monofocal intraocular lens as determined by the investigator

Study Details

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 Dates

Start date
Aug 25, 2020
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
545 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

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

Locations (22)

FacilityCityStateZIPSite coordinators
Coastal VisionIrvineCalifornia92618-
Sacramento Eye ConsultantsSacramentoCalifornia95815-
Eye Center of Northern ColoradoLovelandColorado80538-
Jones Eye Center PCSioux CityIowa51104-
Stiles Eyecare Excellence Cataracts and GlaucomaOverland ParkKansas66213-
Visionary Eye DoctorsRockvilleMaryland20852-
Fraser Eye Care CenterFraserMichigan48026-
Twin Cities Eye ConsultantsCoon RapidsMinnesota55433-
Midwest Vision Research FoundationChesterfieldMissouri63017-
Moyes Eye CenterKansas CityMissouri64154-
Center for SightLas VegasNevada89145-
Carolina Eye Associates PASouthern PinesNorth Carolina28387-
Cleveland Eye ClinicBrecksvilleOhio44141-
Cincinnati Eye InstituteCincinnatiOhio45242-
Cincinnati Eye / Apex EyeMasonOhio45040-
Scott & Christie and Associates, PCCranberry TownshipPennsylvania16066-
Texan Eye / Keystone ResearchAustinTexas78731-
Glaucoma Associates Of TexasDallasTexas75231-
El Paso Eye SurgeonsEl PasoTexas79902-
Texas Eye Research CenterHurstTexas76054-
The Eye Institute of UtahSalt Lake CityUtah84107-
Eye Centers Of Racine And KenoshaKenoshaWisconsin53142-

Find similar trials in Irvine, CA

By research site
Coastal Vision· Irvine, CASacramento Eye Consultants· Sacramento, CAEye Center of Northern Colorado· Loveland, COJones Eye Center PC· Sioux City, IAStiles Eyecare Excellence Cataracts and Glaucoma· Overland Park, KSVisionary Eye Doctors· Rockville, MD

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