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Trabecular Micro-Bypass System

iStent Infinite vs. Competitor Device for Glaucoma

N/A
Waitlist Available
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glaucoma (PEXG) or Secondary Pigmentary Glaucoma (PG)
Be older than 18 years old
Must not have
Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24
Awards & highlights
No Placebo-Only Group

Summary

This trialfound the iStent Infinite product to be effective in treating glaucoma, outperforming its competitor.

Who is the study for?
This trial is for people with specific types of glaucoma: Primary Open-Angle Glaucoma, Secondary Pseudoexfoliative Glacoma, or Secondary Pigmentary Glaucoma. It's not suitable for those with other forms like traumatic, uveitic, neovascular glaucoma, angle closure glaucoma, and any linked to vascular disorders.
What is being tested?
The study compares the iStent Infinite device against a competitor's product in treating open-angle glaucoma. Participants will receive one of these devices to see which is more effective.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, increased eye pressure, inflammation or bleeding inside the eye. These are common risks associated with similar eye procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a specific type of glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a type of glaucoma other than open-angle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mean Diurnal Intraocular Pressure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: iStent InfiniteActive Control1 Intervention
Subjects implanted with iStent Infinite system
Group II: Competitor DeviceActive Control1 Intervention
Subject implanted with competitor device

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
9,159 Total Patients Enrolled

Media Library

iStent Infinite (Trabecular Micro-Bypass System) Clinical Trial Eligibility Overview. Trial Name: NCT05127551 — N/A
Primary Open Angle Glaucoma Research Study Groups: iStent Infinite, Competitor Device
Primary Open Angle Glaucoma Clinical Trial 2023: iStent Infinite Highlights & Side Effects. Trial Name: NCT05127551 — N/A
iStent Infinite (Trabecular Micro-Bypass System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127551 — N/A
~46 spots leftby Nov 2025
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