Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
University of Pennsylvania
Summary
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.
Description
The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation. The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up. Patients will be randomized to 2 tube locations for GDD implantation: * Tube p…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureSulcus tube placement
GDD implantation surgery with tube placement in the ciliary sulcus
- ProcedureAnterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber
Locations (8)
- University of California San FranciscoSan Francisco, California
- Diablo Eye AssociatesWalnut Creek, California
- Bascom Palmer Eye InstituteMiami, Florida
- Wilmer Eye Institute, Johns Hopkins UniversityBaltimore, Maryland
- Massachusetts Eye and EarBoston, Massachusetts
- University of Buffalo/State University of New YorkBuffalo, New York