NCT01539239

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,143 (actual)
• Sponsor: Ivantis, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
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.
PROCEDURE	Cataract surgery	A monofocal intraocular lens (IOL) placed during the cataract surgery.

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-06-01
• Completion: 2020-06-01
• First posted: 2012-02-27
• Last updated: 2021-03-12
• Results posted: 2019-09-06

Locations

38 sites across 9 countries: United States, Canada, Germany, Italy, Mexico, Philippines, Poland, Spain, United Kingdom