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Search / Trial NCT05924477

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Jun 20, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Glaucoma Glaucoma Drainage Device Endothelial Cell Density Endothelial Cell Loss Intraocular Pressure

ClinConnect Summary

The Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a research study designed to compare two different methods of implanting a device that helps manage glaucoma, a condition that affects vision due to increased pressure in the eye. Specifically, the study will look at how these methods impact the health of the cells in the front part of the eye, which are important for clear vision. This trial is currently recruiting participants aged 18 and older who have glaucoma that isn't well controlled with medication and are considering surgery.

To be eligible for the study, participants should not have any major eye conditions that could interfere with the results, and they should not have had certain types of eye surgeries in the past six months. If you decide to participate, you will be randomly assigned to one of the two surgical methods and will need to attend follow-up visits to monitor your progress. This research aims to find the best approach to minimize any potential loss of important eye cells during glaucoma surgery, ultimately helping to preserve vision for those affected by this condition.

Gender

ALL

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

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Miami, Florida, United States

San Francisco, California, United States

Baltimore, Maryland, United States

Chapel Hill, North Carolina, United States

Boston, Massachusetts, United States

Walnut Creek, California, United States

Buffalo, New York, United States

Toronto, , Canada

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported