Trial Summary
What is the purpose of this trial?This trial tests a small device that releases a steroid into the eye during glaucoma surgery to reduce scarring and control eye pressure. It targets patients having glaucoma or combined glaucoma and cataract surgery. The steroid helps reduce inflammation, aiming for better post-surgery outcomes.
Eligibility Criteria
This trial is for adults over 18 with glaucoma, except those with inflammation-related types like uveitis. It's for patients planning to have glaucoma tube implant surgery or combined cataract and glaucoma surgery. Participants must not be pregnant, willing to follow the study plan, and able to give informed consent.Inclusion Criteria
I have been diagnosed with glaucoma, but it's not caused by inflammation or neovascular issues.
I am 18 years old or older.
Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures and are able to provide an informed consent document signed and dated by the subject
+2 more
Exclusion Criteria
Patients who are unlikely to comply with the study protocol
I have or might have an eye infection, including herpes or fungal infections.
I have used or might need drugs that weaken my immune system.
+12 more
Participant Groups
The study tests if a Yutiq steroid insert can safely control eye pressure and reduce scarring when implanted during glaucoma tube implant surgery. The goal is to see if there's a significant difference in eye pressure after 12 weeks compared to surgeries without Yutiq.
2Treatment groups
Experimental Treatment
Active Control
Group I: YutiqExperimental Treatment1 Intervention
A sustained-release steroid insert (Yutiq) will be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery.
Group II: ControlActive Control1 Intervention
Non-study eye will not receive the Yutiq insert
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke Eye CenterDurham, NC
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Who Is Running the Clinical Trial?
Sanjay AsraniLead Sponsor