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A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Sponsor: Sanjay Asrani
Summary
This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 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. The primary aim of this study is to assess the safety and efficacy (controlling intraocular pressure) of the Yutiq inserts to reduce post-operative scarring in surgical glaucoma patients. It is expected that post-operative week 12 onwards there will be a clinically and statistically significant lower IOP in the study eyes than eyes in a group undergoing the same surgery without the Yutiq insert. The estimated duration of the present study is 3 years.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2021-07-20
Completion Date
2027-06
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Yutiq 0.18 MG Drug Implant
a sustained-release steroid insert (Yutiq)
Locations (1)
Duke Eye Center
Durham, North Carolina, United States