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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Germany

Mainz, Germany

Italy

Parma, Italy

Mexico

Tijuana, Mexico

Philippines

Manila, Philippines

Poland

Warsaw, Poland

Spain

Madrid, Spain

Zaragoza, Spain

United Kingdom

London, United Kingdom

Manchester, United Kingdom

Norwich, United Kingdom

Sponsors and Collaborators

Ivantis, Inc.

Investigators

• Principal Investigator: Alan Crandall, MD; The Eye Institute of Utah

  Study Documents (Full-Text)

Documents provided by Ivantis, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] November 1, 2011

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ivantis, Inc.
• ClinicalTrials.gov Identifier: NCT01539239
• Other Study ID Numbers: CP-11-001
• First Posted: February 27, 2012
• Results First Posted: September 6, 2019
• Last Update Posted: March 12, 2021
• Last Verified: February 2021

Keywords provided by Ivantis, Inc.:

Glaucoma; POAG; Cataract

Additional relevant MeSH terms:

Glaucoma; Cataract; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Lens Diseases