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

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrus Aqueous Implant

Device

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.

cataract surgery

Procedure

A monofocal intraocular lens (IOL) placed during the cataract surgery.

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2020
First posted: Feb 27, 2012
Registry last updated: Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed