GlaucomaDECLARENCT05924477
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
A study testing Sulcus tube placement and Anterior chamber (AC) tube placement in people with Glaucoma, run by University of Pennsylvania at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Sulcus tube placement and Anterior chamber (AC) tube placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 11 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, 21287
Pradeep Yammanuru Ramulu, MD, PhD
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Teresa Chen, MD
- Recruiting
University of Buffalo/State University of New York
Buffalo, New York, 14203
Sandra Sieminski, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Rodolfo Bonatti, MD
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Steven Gedde, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Ying Han, MD, PhD
- Recruiting
Diablo Eye Associates
Walnut Creek, California, 94598
Yen Cheng Hsia, MD
Canada1 site, 1 recruiting
- Recruiting
Prism Eye Institute, University of Toronto
Toronto
Iqbal Ike Ahmed, MD, PhD
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Sulcus tube placement, Anterior chamber (AC) tube placement
- Keywords
- glaucoma, glaucoma drainage device, endothelial cell density, endothelial cell loss, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulcus tube placementProcedure or surgery
GDD implantation surgery with tube placement in the ciliary sulcus
Anterior chamber (AC) tube placementProcedure or surgery
GDD implantation surgery with tube placement in the anterior chamber
| Study group | Role | What they receive |
|---|---|---|
| Sulcus tube placement | Active comparator | Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus Receives: Procedure: Sulcus tube placement |
| Anterior chamber (AC) tube placement | Active comparator | Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber Receives: Procedure: Anterior chamber (AC) tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central endothelial cell loss (ECL) from baseline
Change in central endothelial cell density based on assessment of Specular Microscopy images.
Measured: Baseline to 12 months
Secondary outcomes (4)
Intraocular Pressure (IOP) at 12 months
Goldman applanation tonometry (preferred method)
Measured: 12 months after GDD implantation
ECD at 12 months after GDD implantation
ECD measures will be based on the assessment of Specular Microscopy images
Measured: 12 months after GDD implantation
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.
Measured: 12 months after GDD implantation
Number of anti-glaucoma medications at 12 months after GDD implantation
Topical and oral anti-glaucoma medication information is collected at all visits.
Measured: 12 months after GDD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start11 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective 1:1 randomized, parallel design, double-masked clinical trial. Stratification is by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), University of California, San Francisco, Stanford University
- Responsible party
- Sponsor
- Investigators
- Ying Han, MD, PhD, Study chair, University of California, San FranciscoJennifer Rose-Nussbaumer, MD, Study director, Stanford UniversityThuy Doan, MD, PhD, Study director, University of California San Fransicso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924477
- Sponsor's protocol ID
- 853474
- Other IDs
- UG1EY033703
- Acronym
- DECLARE
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
- ClinicalTrials.gov ID
- NCT05924477
- Acronym / sponsor ID
- DECLARE / 853474
- Conditions
- Glaucoma
- Keywords
- glaucoma, glaucoma drainage device, endothelial cell density, endothelial cell loss, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), University of California, San Francisco, Stanford University
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective 1:1 randomized, parallel design, double-masked clinical trial. Stratification is by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification).
| Arm | Type | Receives |
|---|---|---|
| Sulcus tube placement | Active comparator | Procedure: Sulcus tube placementGlaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus |
| Anterior chamber (AC) tube placement | Active comparator | Procedure: Anterior chamber (AC) tube placementGlaucoma drainage device (GDD) implantation with tube placement in the anterior chamber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulcus tube placementGDD implantation surgery with tube placement in the ciliary sulcus | Procedure or surgery | Sulcus tube placement |
| Anterior chamber (AC) tube placementGDD implantation surgery with tube placement in the anterior chamber | Procedure or surgery | Anterior chamber (AC) tube placement |
Primary outcome
Central endothelial cell loss (ECL) from baseline
Time frame: Baseline to 12 months
Change in central endothelial cell density based on assessment of Specular Microscopy images.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulcus tube placement and Anterior chamber (AC) tube placement in people with Glaucoma, run by University of Pennsylvania at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gui-shuang Ying, PhD (215-615-1514, gsying@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central endothelial cell loss (ECL) from baseline (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.