What is the mechanism of action of this treatment?

The Hydrus Microstent is a device implanted during cataract surgery to enhance aqueous humor outflow through the trabecular meshwork, thereby reducing intraocular pressure (IOP) in glaucoma patients. This is crucial as elevated IOP is a major risk factor for glaucoma progression. Other common treatments include prostaglandin analogs, which increase uveoscleral outflow, and beta-blockers, which reduce aqueous humor production. These treatments aim to lower IOP, thereby preventing optic nerve damage and preserving vision.

What side effects are associated with this type of intervention?

Common treatments for glaucoma that enhance aqueous humor outflow through the trabecular meshwork, such as the Hydrus Microstent, trabeculectomy, and other minimally invasive glaucoma surgeries (MIGS), can have side effects including eye irritation, inflammation, and risk of infection. Additionally, there may be transient increases in intraocular pressure post-surgery, and potential for device malposition or failure. Topical medications like prostaglandin analogs and beta-blockers, which also aim to reduce intraocular pressure, can cause side effects such as eye redness, stinging, changes in eye color, and systemic effects like respiratory issues.

What prior FDA approvals exist?

The FDA has approved several treatments for glaucoma that enhance aqueous humor outflow through the trabecular meshwork. These include medications like prostaglandin analogs (e.g., latanoprost, bimatoprost) and surgical devices such as the iStent and the Hydrus Microstent. The Hydrus Microstent, specifically, is designed to be implanted during cataract surgery to improve outflow and reduce intraocular pressure by creating a bypass through the trabecular meshwork, similar to the mechanism being studied in the trial.

What other types of research exist?

Promising novel alternatives to the Hydrus Microstent for glaucoma patients include: 1) iStent inject W: A second-generation trabecular micro-bypass stent that improves aqueous humor outflow. 2) Xen Gel Stent: A gelatin stent that creates a new drainage pathway to reduce intraocular pressure. 3) PreserFlo MicroShunt: A small tube that drains fluid from the anterior chamber to the subconjunctival space. 4) Micropulse Transscleral Cyclophotocoagulation: A laser treatment that reduces intraocular pressure by targeting the ciliary body. These alternatives offer various mechanisms to enhance aqueous humor outflow or reduce intraocular pressure, providing options for personalized glaucoma management.

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Hydrus Microstent for Glaucoma (CONFIRM Trial)

N/A

Recruiting

Research Sponsored by Ivantis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;

An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;

Must not have

Secondary glaucoma;

Congenital or developmental glaucoma;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is evaluating the placement and effects of a tiny device called the Hydrus Microstent in patients having cataract surgery. The device helps drain fluid from the eye to reduce pressure. The study will monitor patients over time to see how well the device works and if there are any issues. The Hydrus Microstent is designed to increase fluid drainage from the eye and lower eye pressure.

Who is the study for?

This study is for people with primary open-angle glaucoma, using up to 4 eye pressure-lowering meds, and having a cataract affecting vision. They must have an eye pressure under 31 mmHg on medication. Not eligible if they've had certain previous eye surgeries or more than 4 medications.

What is being tested?

The trial tests the Hydrus Microstent's position and effects after two years in patients getting cataract surgery with a new lens implant. It checks how well the stent works in controlling glaucoma following the procedure.

What are the potential side effects?

Possible side effects may include discomfort, redness, inflammation, or infection in the eye; changes in vision; increased eye pressure; need for additional procedures; or stent misplacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have primary open angle glaucoma and use up to 4 eye drops for it.

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I have a cataract that affects my vision, making it 20/40 or worse.

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My eye doctor says my optic nerve looks like I have glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have secondary glaucoma.

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I have glaucoma that I was born with or developed early in life.

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I have closed angle glaucoma.

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I have had eye surgery involving the trabecular meshwork or Schlemm's canal.

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I use more than 4 medications for eye pressure.

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I have had previous eye surgeries for glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of occurrence of clinically significant device malposition associated with clinical sequelae

Secondary study objectives

Rate of occurrence of intraoperative ocular adverse events

Rate of occurrence of other postoperative ocular adverse events

Rate of occurrence of sight threatening postoperative adverse events

Other study objectives

Occurrence of non-clinically significant device malposition

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hydrus MicrostentExperimental Treatment3 Interventions

Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrus Microstent

2011

N/A

~680

Cataract surgery

2015

N/A

~3790

Monofocal IOL

2011

N/A

~290

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Hydrus Microstent is a device implanted during cataract surgery to enhance aqueous humor outflow through the trabecular meshwork, thereby reducing intraocular pressure (IOP) in glaucoma patients. This is crucial as elevated IOP is a major risk factor for glaucoma progression. Other common treatments include prostaglandin analogs, which increase uveoscleral outflow, and beta-blockers, which reduce aqueous humor production. These treatments aim to lower IOP, thereby preventing optic nerve damage and preserving vision.