RecruitingNot ApplicableNCT05924477

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial


Sponsor

University of Pennsylvania

Enrollment

226 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two placements of a tube used in glaucoma drainage devices — a tiny implant that helps drain fluid from the eye to lower pressure and prevent vision loss in patients with uncontrolled glaucoma. The trial compares placing the tube in the anterior chamber (front part of the eye) versus the ciliary sulcus (behind the iris), and measures how each affects the corneal endothelial cells (a delicate layer of cells on the surface of the cornea). **You may be eligible if:** - You are 18 or older - You have medically uncontrolled glaucoma requiring a glaucoma drainage device (tube implant), with or without simultaneous cataract surgery - You are a candidate for ciliary sulcus tube placement **You may NOT be eligible if:** - You have a pre-existing corneal disease or previous corneal transplant - You have had a previous glaucoma drainage device, Xen Gel Stent, or Preserflo MicroShunt removed less than 6 months ago - You currently have any of those implants in place - You have had trabeculectomy or minimally invasive glaucoma surgery within the past 6 months - Your glaucoma requires surgery combined with another eye procedure (like a corneal transplant or retinal surgery) - You have very poor vision in the study eye or the other eye - You have nanophthalmos, uncontrolled uveitis, silicone oil, or other special conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESulcus tube placement

GDD implantation surgery with tube placement in the ciliary sulcus

PROCEDUREAnterior chamber (AC) tube placement

GDD implantation surgery with tube placement in the anterior chamber


Locations(8)

University of California San Francisco

San Francisco, California, United States

Diablo Eye Associates

Walnut Creek, California, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

University of Buffalo/State University of New York

Buffalo, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Prism Eye Institute, University of Toronto

Toronto, Canada

View Full Details on ClinicalTrials.gov

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NCT05924477


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