Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
217 participants
INTERVENTIONAL
2017-08-01
2022-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Hydrus Microstent
Device implanted into the Schlemm's canal of the eye for the purpose of providing a natural outflow pathway for aqueous humor. The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
Ophthalmic surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
Interventions
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Hydrus Microstent
Device implanted into the Schlemm's canal of the eye for the purpose of providing a natural outflow pathway for aqueous humor. The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
Ophthalmic surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
Eligibility Criteria
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Inclusion Criteria
* Best Corrected Visual Acuity of 20/80 or better in study eye;
* Refractory glaucoma;
Exclusion Criteria
* Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
* Pre-perimetric glaucoma;
* Ocular hypertension
* Shallow or flat anterior chamber;
45 Years
ALL
No
Sponsors
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Ivantis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Project Lead, CRD Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Vold Vision
Fayetteville, Arkansas, United States
Sacramento Eye Consultants
Sacramento, California, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, United States
Ocala Eye
Ocala, Florida, United States
Center for Sight
Venice, Florida, United States
Stiles Eyecare
Overland Park, Kansas, United States
Louisiana Eye and Laser Center
Alexandria, Louisiana, United States
Washington University in St. Louis Ophthalmology
St Louis, Missouri, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States
Texan Eye
Austin, Texas, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Vale-Asche Russell Clinical Research Center
Houston, Texas, United States
R and R Research, LLC
San Antonio, Texas, United States
The Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States
Clínica Oftalmológica
Barranquilla, , Colombia
Asian Eye Institute
Makati City, , Philippines
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Manchester Royal Eye Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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CP 16-001
Identifier Type: -
Identifier Source: org_study_id