Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

226 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Pennsylvania

Lead sponsor

National Eye Institute (NEI)

Collaborator

University of California, San Francisco

Collaborator

Stanford University

Collaborator