Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Last updated: June 23, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Sulcus tube placement

Anterior chamber (AC) tube placement

Clinical Study ID

NCT05924477
853474
UG1EY033703
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Medically uncontrolled glaucoma requiring GDD or GDD combined withphacoemulsification 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

Exclusion Criteria:

  • Preexisting corneal condition that would affect the corneal endothelium or previouscorneal transplant

  • Presence or history of Cypass Micro-Stent

  • Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 monthsbefore surgery

  • Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt

  • Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6months

  • AC intraocular lens

  • Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndromeor other conditions associated with elevated episcleral venous pressure

  • Unwilling or unable to give consent, unwilling to accept randomization, or unable toreturn 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. cornealtransplant, or retinal surgery) or anticipated need for additional ocular surgery

Study Design

Total Participants: 226
Treatment Group(s): 2
Primary Treatment: Sulcus tube placement
Phase:
Study Start date:
July 11, 2023
Estimated Completion Date:
December 31, 2027

Study 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 placed in the AC

  • Tube placed in ciliary sulcus

  • Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.

Connect with a study center

  • Prism Eye Institute, University of Toronto

    Toronto,
    Canada

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Diablo Eye Associates

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Wilmer Eye Institute, Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Buffalo/State University of New York

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Active - Recruiting

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