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

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Procedure: Cataract surgery; Device: Hydrus Aqueous Implant

• Registration Number: NCT01539239
• Lead Sponsor: Ivantis, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Primary Completion: 2017-06
• Results First Submitted: 2019-08-14
• Results First Submitted QC: 2019-09-05
• Results First Posted: 2019-09-06
• Study Completion: 2020-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cataract Surgery (Control)	Cataract surgery	Cataract surgery only
Hydrus Aqueous Implant (Treatment)	Hydrus Aqueous Implant	Cataract surgery plus Hydrus Aqueous Implant

Primary Outcome Measures

Name	Time	Method
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.	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 Outcome Measures

Name	Time	Method
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.	Baseline and 24 months	Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.