Clinical trial NCT01539239: Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Glaucoma
POAG
Cataract
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 1143
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
timeFrame: Baseline and 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: La Jolla
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Fort Collins
country: United States
state: Colorado
city: Parker
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sioux City
country: United States
state: Iowa
city: Garden City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Sandwich
country: United States
state: Massachusetts
city: Bloomington
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Wilmington
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Maryville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Racine
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Boisbriand
country: Canada
state: Quebec
city: Mainz
country: Germany
city: Parma
country: Italy
city: Tijuana
country: Mexico
city: Manila
country: Philippines
city: Warsaw
country: Poland
city: Madrid
country: Spain
city: Zaragoza
country: Spain
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Norwich
country: United Kingdom
Study officials:
affiliation: The Eye institute of Utah
name: Alan Crandall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.