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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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

CONFIRM Trial Summary

This trial will evaluate the rate of a type of stent called a Hydrus Microstent malposition and its associated clinical problems that occur within 24 months post-operation.

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.Check my eligibility
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.See study design
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.

CONFIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have primary open angle glaucoma and use up to 4 eye drops for it.
Select...
I have a cataract that affects my vision, making it 20/40 or worse.
Select...
My eye doctor says my optic nerve looks like I have glaucoma.

CONFIRM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Secondary outcome measures
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 outcome measures
Occurrence of non-clinically significant device malposition

CONFIRM 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
~670
Cataract surgery
2015
N/A
~3790
Monofocal IOL
2011
N/A
~290

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.

Find a Location

Who is running the clinical trial?

Ivantis, Inc.Lead Sponsor
7 Previous Clinical Trials
2,063 Total Patients Enrolled
7 Trials studying Glaucoma
2,063 Patients Enrolled for Glaucoma
Alcon ResearchLead Sponsor
712 Previous Clinical Trials
125,183 Total Patients Enrolled
146 Trials studying Glaucoma
27,124 Patients Enrolled for Glaucoma
Clinical Project Lead, CDMA SurgicalStudy DirectorAlcon Research
1 Previous Clinical Trials

Media Library

Cataract surgery Clinical Trial Eligibility Overview. Trial Name: NCT04553523 — N/A
Glaucoma Research Study Groups: Hydrus Microstent
Glaucoma Clinical Trial 2023: Cataract surgery Highlights & Side Effects. Trial Name: NCT04553523 — N/A
Cataract surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04553523 — N/A
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