Recruiting

iStent Infinite

Sponsor:

Glaukos Corporation

Code:

NCT06057051

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

iStent Infinite

Study Details

Brief summary:

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Conditions

Glaucoma

Study ID

NCT06057051

Start date

Sep 1, 2023

Status verified date

Sep, 2023

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

245 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iStent Infinite

iStent Infinite Trabecular Micro-Bypass System

Interventions

iStent Infinite

iStent Infinite Trabecular Micro-Bypass System

Primary outcome measure

  • Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Dari Parizadeh

949-481-0575dparizadeh@glaukos.com

Kerry Stephens

949-481-8057kstephens@glaukos.com

Locations

Glaukos Investigator Site

Recruiting

Cincinnati, Ohio, United States, 45242

More Information

Sponsor

Glaukos Corporation

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2023-09-28.