Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Launched by UNIVERSITY OF PENNSYLVANIA · Jun 20, 2023

Keywords

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