Recruiting

Glaucoma Drainage Device vs. Endothelial Cell Loss

Sponsor:

University of Pennsylvania

Code:

NCT05924477

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sulcus tube placement

Anterior chamber (AC) tube placement

Study Details

Brief 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.

Conditions

Glaucoma

Study ID

NCT05924477

Start date

Jul 11, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

226 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sulcus tube placement

Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus

active comparator: Anterior chamber (AC) tube placement

Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber

Interventions

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

Primary outcome measure

  • Central endothelial cell loss (ECL) from baseline [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Gui-shuang Ying, PhD

215-615-1514gsying@pennmedicine.upenn.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Diablo Eye Associates

Recruiting

Walnut Creek, California, United States, 94598

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Wilmer Eye Institute, Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

University of Buffalo/State University of New York

Recruiting

Buffalo, New York, United States, 14203

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27517

Prism Eye Institute, University of Toronto

Recruiting

Toronto, Canada

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • glaucoma
  • glaucoma drainage device
  • endothelial cell density
  • endothelial cell loss
  • intraocular pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-14.