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RecruitingNCT05924477DECLAREUpdated Jul 14, 2026

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

An interventional study of Sulcus tube placement and Anterior chamber (AC) tube placement in Glaucoma, sponsored by University of Pennsylvania. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.
02

Conditions studied

  • Glaucoma

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Keywords

  • glaucoma
  • glaucoma drainage device
  • endothelial cell density
  • endothelial cell loss
  • intraocular pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
226 participants (estimated)

Study arms

  • Active comparator
    Sulcus tube placement

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

    Procedure: Sulcus tube placement

  • Active comparator
    Anterior chamber (AC) tube placement

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

    Procedure: Anterior chamber (AC) tube placement

Interventions

  • ProcedureSulcus tube placement

    GDD implantation surgery with tube placement in the ciliary sulcus

  • ProcedureAnterior chamber (AC) tube placement

    GDD implantation surgery with tube placement in the anterior chamber

05

What researchers measure

Primary outcomes

  1. Central endothelial cell loss (ECL) from baseline

    Change in central endothelial cell density based on assessment of Specular Microscopy images.

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Intraocular Pressure (IOP) at 12 months

    Goldman applanation tonometry (preferred method)

    Time frame: 12 months after GDD implantation

  2. ECD at 12 months after GDD implantation

    ECD measures will be based on the assessment of Specular Microscopy images

    Time frame: 12 months after GDD implantation

  3. Best-corrected visual acuity (BCVA) at 12 months after GDD implantation

    Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.

    Time frame: 12 months after GDD implantation

  4. Number of anti-glaucoma medications at 12 months after GDD implantation

    Topical and oral anti-glaucoma medication information is collected at all visits.

    Time frame: 12 months after GDD implantation

Other outcomes

  1. MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months

    Gene profile analysis evaluating anterior chamber microenvironment (by collecting aqueous fluid samples from the study eye)

    Time frame: 12 months after GDD implantation

  2. Central endothelial cell loss (ECL) from baseline

    Change in central endothelial cell density based on assessment of Specular Microscopy images.

    Time frame: Baseline to 24 months

  3. Intraocular Pressure (IOP) at 24 months

    Goldman applanation tonometry (preferred method)

    Time frame: 24 months after GDD implantation

  4. ECD at 24 months after GDD implantation

    ECD measures will be based on the assessment of Specular Microscopy images

    Time frame: 24 months after GDD implantation

  5. Best-corrected visual acuity (BCVA) at 24 months after GDD implantation

    Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.

    Time frame: 24 months after GDD implantation

  6. Number of anti-glaucoma medications at 24 months after GDD implantation

    Topical and oral anti-glaucoma medication information is collected at all visits.

    Time frame: 24 months after GDD implantation

  7. Safety outcomes: surgical complications

    All AEs, including hypotony, hyphema, tub-related complications, tube exposure, choroidal detachment, corneal decompensation, endophthalmitis and others.

    Time frame: At the GDD surgery visit, and up to 24 months after GDD implantation

06

Study locations

8 of 8 sites recruiting
  • University of California San Francisco
    San Francisco, California 94143, United States
    • Ying Han, MD, PhD · Contact
    Recruiting
  • Diablo Eye Associates
    Walnut Creek, California 94598, United States
    • Yen Cheng Hsia, MD · Contact
    Recruiting
  • Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
    • Steven Gedde, MD · Contact
    Recruiting
  • Wilmer Eye Institute, Johns Hopkins University
    Baltimore, Maryland 21287, United States
    • Pradeep Yammanuru Ramulu, MD, PhD · Contact
    Recruiting
  • Massachusetts Eye and Ear
    Boston, Massachusetts 02114, United States
    • Teresa Chen, MD · Contact
    Recruiting
  • University of Buffalo/State University of New York
    Buffalo, New York 14203, United States
    • Sandra Sieminski, MD · Contact
    Recruiting
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27517, United States
    • Rodolfo Bonatti, MD · Contact
    Recruiting
  • Prism Eye Institute, University of Toronto
    Toronto, Canada
    • Iqbal Ike Ahmed, MD, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05924477
Lead sponsor
University of Pennsylvania
Collaborators
National Eye Institute (NEI), University of California, San Francisco, Stanford University
Responsible party
Sponsor
First posted
Jun 29, 2023
Start date
Jul 11, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 14, 2026

Study contacts

Gui-shuang Ying, PhD
Contact
gsying@pennmedicine.upenn.edu
215-615-1514
Ying Han, MD, PhD
study chair · University of California, San Francisco
Jennifer Rose-Nussbaumer, MD
study director · Stanford University
Thuy Doan, MD, PhD
study director · University of California San Fransicso

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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