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Implantable Device

iStent Inject for Glaucoma

N/A
Waitlist Available
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo cataract surgery
Successful, uncomplicated cataract surgery
Must not have
Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
Angle closure glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the rate of complications from a type of surgery used to treat glaucoma.

Who is the study for?
This study is for men and women over the age of 22 with mild to moderate primary open-angle glaucoma who are scheduled for cataract surgery. Participants must be able to attend follow-up exams for three years and give written consent. Those with conditions like angle closure glaucoma or elevated episcleral venous pressure due to other diseases cannot join.
What is being tested?
The trial is examining the safety of a device called iStent Inject when implanted during post-market use. It aims to track any significant complications that might arise after the device placement in patients undergoing cataract surgery.
What are the potential side effects?
While specific side effects aren't listed, generally, implantation procedures like this could cause eye redness, irritation, infection risk increase, temporary vision disturbances or more rarely impact on eye pressure control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for cataract surgery.
Select...
I had a successful cataract surgery without complications.
Select...
I have been diagnosed with mild to moderate open-angle glaucoma.
Select...
I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My glaucoma is caused by trauma, cancer, inflammation, abnormal blood vessels, or birth defects in the eye.
Select...
I have angle closure glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
iStent inject placement and stability
Secondary study objectives
Sight-threatening adverse events
Other study objectives
Other adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ImplantationExperimental Treatment1 Intervention
Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
67 Previous Clinical Trials
8,980 Total Patients Enrolled

Media Library

iStent Inject Implantation (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04624698 — N/A
Open-Angle Glaucoma Research Study Groups: Implantation
Open-Angle Glaucoma Clinical Trial 2023: iStent Inject Implantation Highlights & Side Effects. Trial Name: NCT04624698 — N/A
iStent Inject Implantation (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624698 — N/A
Open-Angle Glaucoma Patient Testimony for trial: Trial Name: NCT04624698 — N/A
~91 spots leftby May 2026
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