Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE)

June 23, 2025 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sulcus tube placement
Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus
Procedure: Sulcus tube placement
GDD implantation surgery 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
Procedure: Anterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) at 12 months
Time Frame: 12 months after GDD implantation
Goldman applanation tonometry (preferred method)
12 months after GDD implantation
ECD at 12 months after GDD implantation
Time Frame: 12 months after GDD implantation
ECD measures will be based on the assessment of Specular Microscopy images
12 months after GDD implantation
Best-corrected visual acuity (BCVA) at 12 months after GDD implantation
Time Frame: 12 months after GDD implantation
Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.
12 months after GDD implantation
Number of anti-glaucoma medications at 12 months after GDD implantation
Time Frame: 12 months after GDD implantation
Topical and oral anti-glaucoma medication information is collected at all visits.
12 months after GDD implantation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months
Time Frame: 12 months after GDD implantation
Gene profile analysis evaluating anterior chamber microenvironment (by collecting aqueous fluid samples from the study eye)
12 months after GDD implantation
Central endothelial cell loss (ECL) from baseline
Time Frame: Baseline to 24 months
Change in central endothelial cell density based on assessment of Specular Microscopy images.
Baseline to 24 months
Intraocular Pressure (IOP) at 24 months
Time Frame: 24 months after GDD implantation
Goldman applanation tonometry (preferred method)
24 months after GDD implantation
ECD at 24 months after GDD implantation
Time Frame: 24 months after GDD implantation
ECD measures will be based on the assessment of Specular Microscopy images
24 months after GDD implantation
Best-corrected visual acuity (BCVA) at 24 months after GDD implantation
Time Frame: 24 months after GDD implantation
Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.
24 months after GDD implantation
Number of anti-glaucoma medications at 24 months after GDD implantation
Time Frame: 24 months after GDD implantation
Topical and oral anti-glaucoma medication information is collected at all visits.
24 months after GDD implantation
Safety outcomes: surgical complications
Time Frame: At the GDD surgery visit, and up to 24 months after GDD implantation
All AEs, including hypotony, hyphema, tub-related complications, tube exposure, choroidal detachment, corneal decompensation, endophthalmitis and others.
At the GDD surgery visit, and up to 24 months after GDD implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)
University of California, San Francisco
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ying Han, MD, PhD, University of California, San Francisco
  • Study Director: Jennifer Rose-Nussbaumer, MD, Stanford University
  • Study Director: Thuy Doan, MD, PhD, University of California San Fransicso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 853474
  • UG1EY033703 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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