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Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

RecruitingNAAges 18 Years - anyAllUniversity of Pennsylvania
NCT05924477 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Sulcus tube placement
  • Anterior chamber (AC) tube placement
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Where

8 sites
University of California San Francisco
San Francisco, United States
Diablo Eye Associates
Walnut Creek, United States
Bascom Palmer Eye Institute
Miami, United States
Wilmer Eye Institute, Johns Hopkins University
Baltimore, United States
Massachusetts Eye and Ear
Boston, United States
University of Buffalo/State University of New York
Buffalo, United States
University of North Carolina at Chapel Hill
Chapel Hill, United States
Prism Eye Institute, University of Toronto
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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