NCT05924477

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Sulcus tube placement	GDD implantation surgery with tube placement in the ciliary sulcus
PROCEDURE	Anterior chamber (AC) tube placement	GDD implantation surgery with tube placement in the anterior chamber

Timeline

• Start date: 2023-07-11
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-06-29
• Last updated: 2025-06-27

Locations

8 sites across 2 countries: United States, Canada