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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: Hydrus Aqueous Implant
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrus Aqueous Implant (Treatment)<br>Cataract surgery plus Hydrus Aqueous Implant | Device: Hydrus Aqueous Implant<br>* 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.<br>|
| Active Comparator: Cataract Surgery (Control)<br>Cataract surgery only | Procedure: Cataract surgery<br>* A monofocal intraocular lens (IOL) placed during the cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | 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. | Baseline and 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, POAG, Cataract