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Trabecular Micro-Bypass System
iStent Infinite Device for Glaucoma
N/A
Recruiting
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 35 years or older
Diagnosis of primary open-angle glaucoma
Must not have
Retinal disorders not associated with glaucoma
Active corneal inflammation or edema
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new eye device to treat mild-moderate glaucoma in those who haven't responded to other treatments.
Who is the study for?
This trial is for adults aged 35 or older with mild to moderate primary open-angle glaucoma. It's suitable for those who haven't had success with standard treatments and are either phakic (natural lens present) or pseudophakic (artificial lens implanted). People with other types of glaucoma, active corneal issues, or unrelated retinal disorders cannot participate.
What is being tested?
The study is testing the iStent Infinite device in a single group of participants without comparing it to another treatment. This device is designed to help reduce eye pressure in patients by improving fluid drainage from the eyes.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, increased eye pressure, inflammation, bleeding inside the eye, and possible vision disturbances post-procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
Select...
I have been diagnosed with primary open-angle glaucoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a retinal disorder not related to glaucoma.
Select...
I have active inflammation or swelling in my cornea.
Select...
My glaucoma is caused by trauma, inflammation, abnormal blood vessels, or a specific eye structure issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: iStent InfiniteExperimental Treatment1 Intervention
iStent Infinite Trabecular Micro-Bypass System
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Who is running the clinical trial?
Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
9,093 Total Patients Enrolled
36 Trials studying Glaucoma
4,817 Patients Enrolled for Glaucoma