Hydrus Microstent for Refractory Open-Angle Glaucoma

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Ivantis, Inc.
Study ID
NCT03267134
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Hydrus Microstent — DEVICE
    Device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
  • Ophthalmic surgery — PROCEDURE
    Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Study Details

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.

Key Dates

Start date
Aug 1, 2017
Status verified
Dec 2025
Primary completion
Dec 16, 2022
Completion
Dec 16, 2022

Study Design

Enrollment
217 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hydrus Microstent
    Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.

Primary Outcome Measure

Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline [ Time Frame: Baseline, Month 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Vold VisionFayettevilleArkansas72704-
Sacramento Eye ConsultantsSacramentoCalifornia95815-
Eye Center of Northern ColoradoFort CollinsColorado80528-
Ocala EyeOcalaFlorida34474-
Center for SightVeniceFlorida34283-
Stiles EyecareOverland ParkKansas66213-
Louisiana Eye and Laser CenterAlexandriaLouisiana71303-
Washington University in St. Louis OphthalmologySt LouisMissouri63110-
Scott & Christie and AssociatesCranberry TownshipPennsylvania16066-
Texan EyeAustinTexas78731-
Glaucoma Associates of TexasDallasTexas75231-
El Paso Eye SurgeonsEl PasoTexas79902-
Ophthalmology AssociatesFort WorthTexas76102-
Vale-Asche Russell Clinical Research CenterHoustonTexas77030-
R and R Research, LLCSan AntonioTexas78229-
The Eye Centers of Racine and KenoshaKenoshaWisconsin53142-

Find similar trials in Fayetteville, AR

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Vold Vision· Fayetteville, ARSacramento Eye Consultants· Sacramento, CAEye Center of Northern Colorado· Fort Collins, COOcala Eye· Ocala, FLCenter for Sight· Venice, FLStiles Eyecare· Overland Park, KS

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