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Recruiting NCT06057051

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

No phase Interventional Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iStent Infinite.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Device iStent Infinite
    iStent Infinite Trabecular Micro-Bypass System

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Glaukos Investigator Site — Cincinnati

Identifiers

NCT: NCT06057051 · GLK-401-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗