Actively Recruiting
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Led by University of Pennsylvania · Updated on 2025-06-27
226
Participants Needed
8
Research Sites
229 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
- Candidate for GDD implantation for ciliary sulcus and anterior chamber tube placement
- Age greater than or equal to 18 years old
You will not qualify if you...
- Preexisting corneal condition affecting the corneal endothelium or previous corneal transplant
- Presence or history of Cypass Micro-Stent
- Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery
- Presence of GDD implantation, Xen Gel Stent, or Preserflo MicroShunt
- Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
- Anterior chamber intraocular lens
- Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions with elevated episcleral venous pressure
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled visits
- No light perception vision in the study eye or fellow eye visual acuity less than 20/200
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Diablo Eye Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
3
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
4
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
University of Buffalo/State University of New York
Buffalo, New York, United States, 14203
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
8
Prism Eye Institute, University of Toronto
Toronto, Canada
Actively Recruiting
Research Team
G
Gui-shuang Ying, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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