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Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

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ClinicalTrials.gov Identifier: NCT01539239
Recruitment Status : Completed
First Posted : February 27, 2012
Results First Posted : September 6, 2019
Last Update Posted : March 12, 2021
Information provided by (Responsible Party):
Ivantis, Inc.

Brief Summary:
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: Hydrus Aqueous Implant Procedure: Cataract surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
Study Start Date : January 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arm Intervention/treatment
Experimental: Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Device: 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.

Active Comparator: Cataract Surgery (Control)
Cataract surgery only
Procedure: Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.

Primary Outcome Measures :
  1. Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. [ Time Frame: Baseline and 24 months ]
    Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.

Secondary Outcome Measures :
  1. Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. [ Time Frame: Baseline and 24 months ]
    Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • An operable age-related cataract
  • A diagnosis of POAG treated with 1 to 4 hypotensive medications
  • Medicated IOP ≤ 31 mmHg
  • Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg

Exclusion Criteria:

  • Congenital or developmental glaucoma
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539239

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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Fayetteville, Arkansas, United States
United States, California
La Jolla, California, United States
Orange, California, United States
Sacramento, California, United States
United States, Colorado
Fort Collins, Colorado, United States
Parker, Colorado, United States
United States, Florida
Bradenton, Florida, United States
Fort Myers, Florida, United States
Ocala, Florida, United States
United States, Iowa
Sioux City, Iowa, United States
United States, Kansas
Garden City, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Massachusetts
Sandwich, Massachusetts, United States
United States, Minnesota
Bloomington, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, North Carolina
Wilmington, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Mason, Ohio, United States
United States, Tennessee
Maryville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wisconsin
Racine, Wisconsin, United States
Canada, Alberta
Edmonton, Alberta, Canada
Canada, Quebec
Boisbriand, Quebec, Canada
Mainz, Germany
Parma, Italy
Tijuana, Mexico
Manila, Philippines
Warsaw, Poland
Madrid, Spain
Zaragoza, Spain
United Kingdom
London, United Kingdom
Manchester, United Kingdom
Norwich, United Kingdom
Sponsors and Collaborators
Ivantis, Inc.
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Principal Investigator: Alan Crandall, MD The Eye Institute of Utah
  Study Documents (Full-Text)

Documents provided by Ivantis, Inc.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT01539239    
Other Study ID Numbers: CP-11-001
First Posted: February 27, 2012    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: March 12, 2021
Last Verified: February 2021
Keywords provided by Ivantis, Inc.:
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases