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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am scheduled for cataract surgery.
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I had a successful cataract surgery without complications.
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I have been diagnosed with mild to moderate open-angle glaucoma.
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I am 22 years old or older.

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

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

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
65 Previous Clinical Trials
8,682 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of enrolment in this clinical trial?

"Affirmative. Clinicaltrials.gov furnishes information which verifies that the current recruitment for this clinical trial commenced on September 22nd 2020 and was recently updated on March 28th 2022, with a need to enlist 358 patients from 3 distinct locations."

Answered by AI

Are there vacancies currently available for participants of this research project?

"Affirmative. Clinicaltrials.gov's data shows that this research project, which was first published on September 22nd 2020, is currently seeking volunteers. The total number of patients being recruited across the 3 sites stands at 358 individuals."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Eye Doctors of Arizona, PLLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I gave severe glaucoma which has led to my blindness so, I want to see again and help others with a cure.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
iStent Inject New Enrollment Post-Approval Study
2020. "iStent Inject New Enrollment Post-Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04624698.
All > Glaucoma Long Beach > Glaucoma
~128 spots leftby May 2026
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