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Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two places to put a glaucoma drainage device: the front chamber of the eye and a small space near the iris, the colored part of the eye. It aims to find which place leads to less cell loss in the eye. It is for adults whose glaucoma is not controlled by medicine and who need drainage device surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • Your glaucoma is not controlled by medicine, and you need a glaucoma drainage device, with or without cataract surgery.
  • You can have the drainage tube placed in either of the two locations being studied.

Who can't join

  • You have a condition that affects cells lining the cornea, the clear front of the eye, or you have had a cornea transplant.
  • You have or have ever had a Cypass Micro-Stent. You currently have a glaucoma drainage device, Xen Gel Stent, or Preserflo MicroShunt, or had one removed less than 6 months before surgery. These devices help drain eye fluid.
  • You had trabeculectomy or minimally invasive glaucoma surgery, which help lower eye pressure, within the past 6 months.
  • You have an artificial lens in the front chamber of your eye.
  • You have an unusually small eye, uncontrolled swelling inside the eye, silicone oil in the eye, Sturge-Weber syndrome, or another condition linked to high pressure in veins on the eye's surface.
  • You cannot or do not want to give consent, do not accept a study group chosen by chance, or cannot return for scheduled study visits.
  • You cannot see light in the study eye, or vision in your other eye is worse than 20/200.
  • You need glaucoma surgery together with another eye procedure, such as a cornea transplant or retina surgery, or are expected to need another eye surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (7)

CA

FL

MA

MD

  • Wilmer Eye Institute, Johns Hopkins University · Baltimore, MD 21287Pradeep Yammanuru Ramulu, MD, PhD · Study contactMore trials in Baltimore

NC

  • University of North Carolina at Chapel Hill · Chapel Hill, NC 27517Rodolfo Bonatti, MD · Study contactMore trials in Chapel Hill

NY

  • University of Buffalo/State University of New York · Buffalo, NY 14203Sandra Sieminski, MD · Study contactMore trials in Buffalo