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Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial — DECLARE  

Glaucoma Clinical Trial

Official title:
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05924477
Study type Interventional
Source University of Pennsylvania
Contact Gui-shuang Ying, PhD
Phone 215-615-1514
Email gsying@pennmedicine.upenn.edu
Status Recruiting
Phase N/A
Start date July 11, 2023
Completion date December 2027
View Details
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