Glaucoma Drainage Device and Endothelial Cell Loss Compare 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
| Condition(s) | Glaucoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Pennsylvania |
| Locations | San Francisco, California, United States; Walnut Creek, California, United States; Miami, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Buffalo, New York, United States (+2 more sites) |
| Start date | 2023-07-11 |
| NCT ID | NCT05924477 |
| Official listing | https://clinicaltrials.gov/study/NCT05924477 |