Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Procedure: Sulcus tube placement; Procedure: Anterior chamber (AC) tube placement

• Registration Number: NCT05924477
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-29
• Study Start: 2023-07-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulcus tube placement	Sulcus tube placement	Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus
Anterior chamber (AC) tube placement	Anterior chamber (AC) tube placement	Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber

Primary Outcome Measures

Name	Time	Method
Central endothelial cell loss (ECL) from baseline	Baseline to 12 months	Change in central endothelial cell density based on assessment of Specular Microscopy images.

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at 12 months	12 months after GDD implantation	Goldman applanation tonometry (preferred method)
ECD at 12 months after GDD implantation	12 months after GDD implantation	ECD measures will be based on the assessment of Specular Microscopy images
Best-corrected visual acuity (BCVA) at 12 months after GDD implantation	12 months after GDD implantation	Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.
Number of anti-glaucoma medications at 12 months after GDD implantation	12 months after GDD implantation	Topical and oral anti-glaucoma medication information is collected at all visits.

Trial Locations

Locations (5)

University of Buffalo/State University of New York; 🇺🇸 Buffalo, New York, United States

Prism Eye Institute, University of Toronto; 🇨🇦 Toronto, Canada

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States