Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05924477

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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