Clinical trial NCT05924477: Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Official title: Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
glaucoma drainage device
endothelial cell density
endothelial cell loss
intraocular pressure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: University of California, San Francisco
name: Stanford University
First posted: 2023-06-29
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

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.

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
* Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or 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

Primary outcomes:
measure: Central endothelial cell loss (ECL) from baseline
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Intraocular Pressure (IOP) at 12 months
timeFrame: 12 months after GDD implantation
measure: ECD at 12 months after GDD implantation
timeFrame: 12 months after GDD implantation
measure: Best-corrected visual acuity (BCVA) at 12 months after GDD implantation
timeFrame: 12 months after GDD implantation
measure: Number of anti-glaucoma medications at 12 months after GDD implantation
timeFrame: 12 months after GDD implantation
Other outcomes:
measure: MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months
timeFrame: 12 months after GDD implantation
measure: Central endothelial cell loss (ECL) from baseline
timeFrame: Baseline to 24 months
measure: Intraocular Pressure (IOP) at 24 months
timeFrame: 24 months after GDD implantation
measure: ECD at 24 months after GDD implantation
timeFrame: 24 months after GDD implantation
measure: Best-corrected visual acuity (BCVA) at 24 months after GDD implantation
timeFrame: 24 months after GDD implantation
measure: Number of anti-glaucoma medications at 24 months after GDD implantation
timeFrame: 24 months after GDD implantation
measure: Safety outcomes: surgical complications
timeFrame: At the GDD surgery visit, and up to 24 months after GDD implantation
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Buffalo
country: United States
facility: University of Buffalo/State University of New York
state: New York
city: Toronto
country: Canada
facility: Prism Eye Institute, University of Toronto
Study officials:
affiliation: University of California, San Francisco
name: Ying Han, MD, PhD
role: STUDY_CHAIR
affiliation: Stanford University
name: Jennifer Rose-Nussbaumer, MD
role: STUDY_DIRECTOR
affiliation: University of California San Fransicso
name: Thuy Doan, MD, PhD
role: STUDY_DIRECTOR
References: