Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Pennsylvania
Study ID
NCT05924477
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sulcus tube placement — PROCEDURE
    GDD implantation surgery with tube placement in the ciliary sulcus
  • Anterior chamber (AC) tube placement — PROCEDURE
    GDD implantation surgery with tube placement in the anterior chamber

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Ying Han, MD, PhD
Diablo Eye AssociatesWalnut CreekCalifornia94598
Yen Cheng Hsia, MD
Bascom Palmer Eye InstituteMiamiFlorida33136
Steven Gedde, MD
Wilmer Eye Institute, Johns Hopkins UniversityBaltimoreMaryland21287
Pradeep Yammanuru Ramulu, MD, PhD
Massachusetts Eye and EarBostonMassachusetts02114
Teresa Chen, MD
University of Buffalo/State University of New YorkBuffaloNew York14203
Asher Weiner, MD
University of North Carolina at Chapel HillChapel HillNorth Carolina27517
Donald Budenz, MD

Find similar trials in San Francisco, CA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
University of California San Francisco· San Francisco, CADiablo Eye Associates· Walnut Creek, CABascom Palmer Eye Institute· Miami, FLWilmer Eye Institute, Johns Hopkins University· Baltimore, MDMassachusetts Eye and Ear· Boston, MAUniversity of Buffalo/State University of New York· Buffalo, NY

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