Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
NCT ID: NCT01539239
Last Updated: 2021-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1143 participants
INTERVENTIONAL
2012-01-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Cataract Surgery (Control)
Cataract surgery only
Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.
Interventions
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Hydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of POAG treated with 1 to 4 hypotensive medications
* Medicated IOP ≤ 31 mmHg
* Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg
Exclusion Criteria
* Previous argon laser trabeculoplasty
* Ab-interno or ab-externo device implanted in or through Schlemm's Canal
* Use of oral hypotensive medication for glaucoma for treatment of fellow eye
45 Years
ALL
No
Sponsors
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Ivantis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Crandall, MD
Role: PRINCIPAL_INVESTIGATOR
The Eye institute of Utah
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
La Jolla, California, United States
Orange, California, United States
Sacramento, California, United States
Fort Collins, Colorado, United States
Parker, Colorado, United States
Bradenton, Florida, United States
Fort Myers, Florida, United States
Ocala, Florida, United States
Sioux City, Iowa, United States
Garden City, Kansas, United States
Louisville, Kentucky, United States
Sandwich, Massachusetts, United States
Bloomington, Minnesota, United States
Chesterfield, Missouri, United States
Wilmington, North Carolina, United States
Cleveland, Ohio, United States
Mason, Ohio, United States
Maryville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Racine, Wisconsin, United States
Edmonton, Alberta, Canada
Boisbriand, Quebec, Canada
Mainz, , Germany
Parma, , Italy
Tijuana, , Mexico
Manila, , Philippines
Warsaw, , Poland
Madrid, , Spain
Zaragoza, , Spain
London, , United Kingdom
Manchester, , United Kingdom
Norwich, , United Kingdom
Countries
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References
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Zebardast N, Zheng C, Jampel HD. Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial. Ophthalmology. 2020 Oct;127(10):1303-1310. doi: 10.1016/j.ophtha.2020.01.025. Epub 2020 Jan 23.
Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-11-001
Identifier Type: -
Identifier Source: org_study_id
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