Comparing two methods of glaucoma drainage device implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Gui-shuang Ying, PhD
• Email: gsying@pennmedicine.upenn.edu
• Phone: 215-615-1514

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.