A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Glaucoma

Clinical Trial Details

NCT number	NCT04918121
Study type	Interventional
Source	Duke University
Contact	Sarah Jones
Phone	1-919-681-6584
Email	sarah.jones1@duke.edu
Status	Recruiting
Phase	Early Phase 1
Start date	July 20, 2021
Completion date	December 2024

View Details

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