Comparing two methods of glaucoma drainage device implantation
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
This study is testing whether placing a glaucoma drainage device in the front part of the eye or in a different spot helps people with glaucoma manage their eye pressure and cell health better over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT05924477 on ClinicalTrials.gov |
What this trial studies
The DECLARE Trial is a multi-center, randomized clinical trial designed to compare the effects of glaucoma drainage device (GDD) implantation in two different locations: the anterior chamber and the ciliary sulcus. This study aims to assess the impact of these placements on endothelial cell density and intraocular pressure over a 12-month follow-up period, with an extended follow-up of 24 months for additional outcomes. Participants will be randomly assigned to one of the two tube placement groups, ensuring balanced representation across clinical centers and surgical types. The trial employs a double-masked design to minimize bias in outcome assessment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with medically uncontrolled glaucoma requiring a glaucoma drainage device.
Not a fit: Patients with preexisting corneal conditions or those who have undergone previous glaucoma surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize endothelial cell loss in glaucoma patients.
How similar studies have performed: Other studies have explored similar surgical techniques, but this specific comparison of tube placement locations is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 7 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Diablo Eye Associates — Walnut Creek, California, United States (Recruiting)
- Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
- Wilmer Eye Institute, Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
- University of Buffalo/State University of New York — Buffalo, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Prism Eye Institute, University of Toronto — Toronto, Canada (Recruiting)
Study contacts
- Study coordinator: Gui-shuang Ying, PhD
- Email: gsying@pennmedicine.upenn.edu
- Phone: 215-615-1514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.