iStent Inject New Enrollment Post-Approval Study

NCT ID: NCT04624698

Last Updated: 2024-02-23

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2026-05-31

Brief Summary

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Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

Detailed Description

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To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

Conditions

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Glaucoma, Open-Angle 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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Implantation

Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.

Group Type EXPERIMENTAL

iStent Inject Implantation

Intervention Type DEVICE

Subjects will be implanted with the iStent Injection Micro-Bypass device

Interventions

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iStent Inject Implantation

Subjects will be implanted with the iStent Injection Micro-Bypass device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female ≥ 22 years of age
2. Mild to moderate primary open-angle glaucoma
3. Scheduled to undergo cataract surgery
4. Able and willing to attend scheduled follow-up exams for three years postoperatively
5. Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Operative Inclusion Criterion:
6. Successful, uncomplicated cataract surgery

Exclusion Criteria

1. Angle closure glaucoma
2. Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
3. Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Minimum Eligible Age

22 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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Eye Doctors of Arizona, PLLC

Phoenix, Arizona, United States

Site Status

Wolstan and Goldberg Eye Associates

Torrance, California, United States

Site Status

Glaucoma Associates of Texas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IG2M-105-PASN

Identifier Type: -

Identifier Source: org_study_id

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