Treatment for mild to moderate primary open-angle glaucoma using the iStent Infinite device
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06057051 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies involving similar micro-bypass devices have shown promising results in managing glaucoma, indicating a potential for success in this approach.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- Glaukos Investigator Site — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Dari Parizadeh
- Email: dparizadeh@glaukos.com
- Phone: 949-481-0575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.