Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Description

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.

Conditions

Glaucoma

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Study Overview

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Study Details

Study overview

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.

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Condition
Glaucoma
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Miami

Bascom Palmer Eye Institute, Miami, Florida, United States, 33136

Boston

Massachusetts Eye and Ear, Boston, Massachusetts, United States, 02114

Buffalo

University of Buffalo/State University of New York, Buffalo, New York, United States, 14203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Ying Han, MD, PhD, STUDY_CHAIR, University of California, San Francisco

Jennifer Rose-Nussbaumer, MD, STUDY_DIRECTOR, Stanford University

Thuy Doan, MD, PhD, STUDY_DIRECTOR, University of California San Fransicso

Study Record Dates

2027-12