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

NCT ID: NCT06057051

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2027-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iStent Infinite

iStent Infinite Trabecular Micro-Bypass System

Group Type EXPERIMENTAL

iStent Infinite

Intervention Type DEVICE

iStent Infinite Trabecular Micro-Bypass System

Interventions

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iStent Infinite

iStent Infinite Trabecular Micro-Bypass System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Glaukos Investigator Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dari Parizadeh

Role: CONTACT

949-481-0575

Kerry Stephens

Role: CONTACT

949-481-8057

Facility Contacts

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Dari Parizadeh

Role: primary

Other Identifiers

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GLK-401-01

Identifier Type: -

Identifier Source: org_study_id

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