Sulcus tube placement: GDD implantation surgery with tube placement in the ciliary sulcus
Anterior chamber (AC) tube placement: GDD implantation surgery with tube placement in the anterior chamber
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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
Primary outcome measure(s)
Central endothelial cell loss (ECL) from baseline — Baseline to 12 months Change in central endothelial cell density based on assessment of Specular Microscopy images.
Trial sites (8)
Facility
City
Region
Status
University of California San Francisco
San Francisco
California
Recruiting
Diablo Eye Associates
Walnut Creek
California
Recruiting
Bascom Palmer Eye Institute
Miami
Florida
Recruiting
Wilmer Eye Institute, Johns Hopkins University
Baltimore
Maryland
Recruiting
Massachusetts Eye and Ear
Boston
Massachusetts
Recruiting
University of Buffalo/State University of New York
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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