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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am 35 years old or older.

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I have been diagnosed with primary open-angle glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline

Trial Design

1Treatment groups

Experimental Treatment

Group I: iStent InfiniteExperimental Treatment1 Intervention

iStent Infinite Trabecular Micro-Bypass System

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor

65 Previous Clinical Trials

8,795 Total Patients Enrolled

35 Trials studying Glaucoma

4,729 Patients Enrolled for Glaucoma

Frequently Asked Questions

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

To what extent is the current clinical trial being utilized by participants?

"Affirmative. Clinicaltrials.gov has information that this clinical study is currently accepting participants - the research was uploaded on September 1st 2023 and recently updated on September 26th 2023. This trial is looking for 245 individuals to enroll at one medical centre."

Answered by AI

Is it possible to enroll in the trial at this time?

"Affirmative. Clinicaltrials.gov holds evidence that this medical examination is actively recruiting subjects, having first been posted on September 1st 2023 and most recently updated on the 26th of the same month. The trial necessitates 245 people at a single location to participate in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

2023. "Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057051.

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