Clinical trial Recruiting at 1 site Interventional Ages 35 and up

Treatment for mild to moderate primary open-angle glaucoma using the iStent Infinite device

Official title: A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma

Run by Glaukos Corporation · NCT06057051 · Data updated 2026-11-12

This study is testing a new device called the iStent Infinite to see if it can help adults with mild to moderate glaucoma who haven't had success with other treatments.

Quick facts

Study typeInterventional
Ages35 Years and up
SexAll
Enrollment245 (estimated)
SponsorGlaukos Corporation
Industry-sponsored
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedSeptember 1, 2023
Main results expectedAugust 2025
Study endsAugust 2027
Registry record updatedSeptember 28, 2023
Trial IDNCT06057051 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 35 years or older with a diagnosis of mild to moderate primary open-angle glaucoma who are either phakic or pseudophakic.

Probably not a fit

Patients with traumatic, uveitic, neovascular, or angle-closure glaucoma, as well as those with active corneal inflammation or retinal disorders not associated with glaucoma, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the iStent Infinite Trabecular Micro-Bypass System in adults diagnosed with mild to moderate primary open-angle glaucoma. It is a prospective, multicenter, single-arm study focusing on patients who have not responded to conventional medical and surgical treatments. Participants will be monitored for improvements in intraocular pressure and overall eye health following the intervention. The study aims to provide insights into the safety and efficacy of this innovative device in managing glaucoma.

Why it matters

Potential benefit: If successful, this treatment could significantly improve intraocular pressure control and reduce the need for additional glaucoma medications or surgeries.

How similar studies have gone: Other studies involving similar micro-bypass devices have shown promising results in managing glaucoma, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma
* Phakic or pseudophakic
* Age 35 years or older

Exclusion Criteria:

* Traumatic, uveitic, neovascular, angle-closure glaucoma or
* glaucoma associated with vascular disorders
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma

Where it's running

  • Glaukos Investigator Site
    Cincinnati, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.