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

Completed · Not applicable

Conditions studied: Primary Open Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT01539239

Run by

Ivantis, Inc.

People needed

1143

Starts

2012-01-01

Expected to finish

2020-06-01

Last updated by the study team

2021-03-12

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — La Jolla, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Parker, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Sioux City, Iowa, United States
• Study site — Garden City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Sandwich, Massachusetts, United States
• Study site — Bloomington, Minnesota, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Mason, Ohio, United States
• Study site — Maryville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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