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

Ivantis

Status: Completed

Conditions: Primary Open Angle Glaucoma

Treatments: Device: Hydrus Aqueous Implant; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539239

CP-11-001

Details and patient eligibility

About

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.

Enrollment: 1,143 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,143 participants in 2 patient groups

Hydrus Aqueous Implant (Treatment)

Experimental group

Description:

Cataract surgery plus Hydrus Aqueous Implant

Treatment:

Device: Hydrus Aqueous Implant

Cataract Surgery (Control)

Active Comparator group

Description:

Cataract surgery only

Treatment:

Procedure: Cataract surgery