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OpenTrials
Recruiting

NCT Number: NCT06057051

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

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

Recruiting

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glaukos Investigator Site

Cincinnati, Ohio, 45242, United States

Location status: Recruiting

Location contact

Dari Parizadeh

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStent Infinite

Device

iStent Infinite Trabecular Micro-Bypass System

Primary outcomes

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

    Time frame: 12 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Dari Parizadeh

CONTACT

[email protected]

949-481-0575

Kerry Stephens

CONTACT

[email protected]

949-481-8057

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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