Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

{ "Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE)", "This study, called DECLARE, is comparing two ways to place a glaucoma drainage device (GDD) during surgery for medically uncontrolled glaucoma. You might be able to join if you are at least 18 years old and need a GDD, or a GDD combined with cataract surgery (phacoemulsification). Researchers want to see if placing the GDD tube in the anterior chamber (front part of the eye) or the ciliary sulcus (a small space between the iris and the front chamber of the eye) leads to less central endothelial cell loss (ECL) in your eye. This cell loss is measured over 12 months. The study is looking for 226 participants, but its current status is unclear.", "design": "This is a randomized study, meaning you would be assigned by chance to one of two groups. It is also \"double-masked,\" so neither you nor your doctors will know which tube placement you receive.", "commitments": "You would undergo GDD implantation surgery with either sulcus tube placement or anterior chamber tube placement. You will be followed for 12 months for the main outcome, and then for a total of 24 months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 12 months for the primary outcome, and then for a total of 24 months.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05924477

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Recruiting
NAAges 18+InterventionalTreatment
University of Pennsylvania
~226 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Sulcus tube placementAnterior chamber (AC) tube placement

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Central endothelial cell loss (ECL) from baseline
Measured over Baseline to 12 months
Glaucoma
8 sites across 7 states
California2
Florida1
Maryland1
Massachusetts1
New York1
North Carolina1
Canada1
  • Ying Han, MD, PhD · STUDY_CHAIR · University of California, San Francisco
  • Jennifer Rose-Nussbaumer, MD · STUDY_DIRECTOR · Stanford University
  • Thuy Doan, MD, PhD · STUDY_DIRECTOR · University of California San Fransicso

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Eligibility criteria

Inclusion

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

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
  • Central endothelial cell loss (ECL) from baselineBaseline to 12 months

    Change in central endothelial cell density based on assessment of Specular Microscopy images.