Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
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
1 other identifier
interventional
1,143
9 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedResults Posted
Study results publicly available
September 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 12, 2021
February 1, 2021
5.4 years
February 21, 2012
August 14, 2019
February 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
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.
Baseline and 24 months
Secondary Outcomes (1)
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
Baseline and 24 months
Study Arms (2)
Hydrus Aqueous Implant (Treatment)
EXPERIMENTALCataract surgery plus Hydrus Aqueous Implant
Cataract Surgery (Control)
ACTIVE COMPARATORCataract surgery only
Interventions
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.
A monofocal intraocular lens (IOL) placed during the cataract surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ivantis, Inc.lead
Study Sites (38)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fayetteville, Arkansas, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Orange, California, United States
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Sacramento, California, United States
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Fort Collins, Colorado, United States
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Parker, Colorado, United States
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
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Ocala, Florida, United States
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Sioux City, Iowa, United States
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Garden City, Kansas, United States
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Louisville, Kentucky, United States
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Sandwich, Massachusetts, United States
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Bloomington, Minnesota, United States
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Chesterfield, Missouri, United States
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Wilmington, North Carolina, United States
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Cleveland, Ohio, United States
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Mason, Ohio, United States
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Maryville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Salt Lake City, Utah, United States
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Racine, Wisconsin, United States
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Edmonton, Alberta, Canada
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Boisbriand, Quebec, Canada
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Mainz, Germany
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Parma, Italy
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Tijuana, Mexico
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Manila, Philippines
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Warsaw, Poland
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Madrid, Spain
Unknown Facility
Zaragoza, Spain
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Norwich, United Kingdom
Related Publications (2)
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.
PMID: 32143828DERIVEDSamuelson 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.
PMID: 29945799DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Hope
- Organization
- Ivantis
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Crandall, MD
The Eye institute of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
February 27, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2017
Study Completion
June 1, 2020
Last Updated
March 12, 2021
Results First Posted
September 6, 2019
Record last verified: 2021-02