Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Recruiting now · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT05924477

Run by

University of Pennsylvania

People needed

226

Starts

2023-07-11

Expected to finish

2027-12-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
• Candidate for GDD implantation for ciliary sulcus and AC tube
• Age greater than or equal to 18 years old

You may not qualify if…

• Preexisting corneal condition that would affect 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, of Preserflo MicroShunt
• Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
• AC intraocular lens
• Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
• No light perception vision in the study eye or fellow eye visual acuity < 20/200
• Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery

Where it is running

• University of California San Francisco — San Francisco, California, United States (enrolling)
• Diablo Eye Associates — Walnut Creek, California, United States (enrolling)
• Bascom Palmer Eye Institute — Miami, Florida, United States (enrolling)
• Wilmer Eye Institute, Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)
• University of Buffalo/State University of New York — Buffalo, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Prism Eye Institute, University of Toronto — Toronto, Canada (enrolling)

Full record on ClinicalTrials.gov

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