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NCT05924477Recruiting

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
226 (estimated)
First submitted
8 Jun 2023
Start date
11 Jul 2023
Primary completion date
31 Dec 2026
Lead sponsor
University of Pennsylvania
Diseases
Glaucoma
NCT number
NCT05924477

What you commit to

  • Study type: Interventional
  • Planned participants: 226
  • From 11 Jul 2023 to the primary completion date, 31 Dec 2026
  • 8 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant
  • Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery
  • Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
  • Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery

Other illness

  • Presence or history of Cypass Micro-Stent
  • Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure

Other

  • Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt
  • AC intraocular lens
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Prism Eye Institute, University of Toronto
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Wilmer Eye Institute, Johns Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Massachusetts Eye and Ear
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Buffalo/State University of New York
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Bascom Palmer Eye Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Diablo Eye Associates
Coordinator of this site? Confirm its status
Walnut CreekUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.