iStent Inject for Glaucoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Glaukos Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for cataract surgery.

I had a successful cataract surgery without complications.

I have been diagnosed with mild to moderate open-angle glaucoma.

+3 more

Exclusion Criteria

My glaucoma is caused by trauma, cancer, inflammation, abnormal blood vessels, or birth defects in the eye.

I have a condition that increases pressure in my eye veins.

I have angle closure glaucoma.

Participant Groups

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.

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.