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

University of Pennsylvania

Status: Enrolling

Conditions: Glaucoma

Treatments: Procedure: Sulcus tube placement; Procedure: Anterior chamber (AC) tube placement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05924477

853474

UG1EY033703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

226 participants in 2 patient groups

Sulcus tube placement

Active Comparator group

Description:

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

Treatment:

Procedure: Sulcus tube placement

Anterior chamber (AC) tube placement

Active Comparator group

Description:

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

Treatment:

Procedure: Anterior chamber (AC) tube placement