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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
~3910
Monofocal IOL
2011
N/A
~290

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
704 Previous Clinical Trials
123,966 Total Patients Enrolled
145 Trials studying Glaucoma
26,674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are registered for this research project?

"Ivantis, Inc., the trial sponsor needs 330 qualified participants to complete this study. These tests are being conducted in multiple locations across the USA including Coastal Vision in Orange County and North Suburban Eye Specialists located in Minnesota's Coon Rapids."

Answered by AI

What goals are the researchers expecting to achieve by conducting this medical experiment?

"According to the clinical trial sponsor, Ivantis, Inc., this research will measure a primary outcome over 24 months: clinically significant device malposition. Additionally, secondary objectives that are being assessed include rate of sight threatening post-operative adverse events (such as endophthalmitis and choroidal hemorrhage), other postoperative ocular adverse events (including anterior uveitis/iritis and BCVA loss) and intraoperative ocular adverse events (e.g hyphema obscuring surgeon's view)."

Answered by AI

What is the present number of medical facilities conducting this experiment?

"The trial is recruiting from 14 sites, including Coastal Vision in Orange, North Suburban Eye Specialists in Coon Rapids, The Eye Centers of Racine and Kenosha LTD in Kenosha. Additional medical centres are participating as well."

Answered by AI

Is recruitment currently open for this experiment?

"Affirmative. Records on clinicaltrials.gov demonstrate that this research trial, which was posted on August 25th 2020, is recruiting participants now. The requirement for 330 patients needs to be fulfilled across 14 different medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Keystone Research
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Hydrus® Microstent New Enrollment Post-Approval Study
2020. "Hydrus® Microstent New Enrollment Post-Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04553523.
All > Glaucoma Long Beach > Glaucoma
~229 spots leftby Jan 2027
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