Menu
Recruiting NCT05924477

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

No phase Interventional Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sulcus tube placement, Anterior chamber (AC) tube placement.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Central endothelial cell loss (ECL) from baseline [Time frame: Baseline to 12 months]
Secondary outcome measures (4)
  • Intraocular Pressure (IOP) at 12 months [Time frame: 12 months after GDD implantation]
  • ECD at 12 months after GDD implantation [Time frame: 12 months after GDD implantation]
  • Best-corrected visual acuity (BCVA) at 12 months after GDD implantation [Time frame: 12 months after GDD implantation]
  • Number of anti-glaucoma medications at 12 months after GDD implantation [Time frame: 12 months after GDD implantation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 7 centers
  • University of California San Francisco — San Francisco
  • Diablo Eye Associates — Walnut Creek
  • Bascom Palmer Eye Institute — Miami
  • Wilmer Eye Institute, Johns Hopkins University — Baltimore
  • Massachusetts Eye and Ear — Boston
  • University of Buffalo/State University of New York — Buffalo
  • University of North Carolina at Chapel Hill — Chapel Hill
Canada · 1 center
  • Prism Eye Institute, University of Toronto — Toronto

Identifiers

NCT: NCT05924477 · 853474 · UG1EY033703

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗