Glaucoma Drainage Techniques for Glaucoma
(DECLARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two methods of placing glaucoma drainage devices in the eye to determine which causes less cell loss. It compares device placement in the anterior chamber (front part of the eye) versus the sulcus (a small space between the iris and the front chamber). People with medication-resistant glaucoma who need a drainage device may be suitable candidates. Participants will help identify the best approach to minimize damage while treating glaucoma. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future glaucoma treatments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these glaucoma drainage techniques are safe?
Research shows that both types of tube placement for glaucoma drainage—one in the front part of the eye (anterior chamber) and the other in a groove behind the iris (sulcus)—are generally safe. Most surgeons prefer placing the tube in the front part because they are more familiar with it and it is quicker. However, some risks exist. Studies indicate that after surgery, about 15% of patients may experience a temporary decrease in the fluid-filled space in the front of the eye, and about 10% may have low eye pressure that needs treatment.
Placing the tube in the groove behind the iris is a newer but promising method. It effectively reduces the pressure inside the eye with few complications. Some concerns include possible bleeding inside the eye and the need for a skilled surgeon to perform the procedure. However, research suggests that this method may cause less damage to the clear front surface of the eye (cornea) compared to the front placement.
For those considering joining a trial, both methods have been studied and are considered safe, each with its own advantages and disadvantages.12345Why are researchers excited about this trial?
Researchers are excited about these glaucoma drainage techniques because they explore two different tube placements for managing glaucoma, offering potential improvements over standard treatments like medications or traditional surgeries. The anterior chamber (AC) tube placement involves positioning the drainage tube directly into the front part of the eye, which might enhance fluid outflow and reduce eye pressure more effectively. Meanwhile, the sulcus tube placement targets the ciliary sulcus, a different part of the eye, which could offer a more tailored approach to managing fluid drainage and pressure control. By examining these distinct placements, researchers hope to discover more efficient and personalized options for reducing the pressure that harms the optic nerve in glaucoma patients.
What evidence suggests that these glaucoma drainage techniques are effective for minimizing cell loss?
This trial will compare two types of tube placements for glaucoma: one in the front part of the eye (anterior chamber) and the other in a groove behind the iris (sulcus). Research has shown that both methods effectively lower eye pressure and are generally safe. Participants in the anterior chamber tube placement arm may benefit from its high success rate; one study showed a 91% success rate over two years. Meanwhile, those in the sulcus tube placement arm may experience a success rate of 85.3% over the long term, with fewer issues affecting the cornea, the eye's clear outer layer. Overall, both methods are promising for managing glaucoma by effectively reducing eye pressure.16789
Who Is on the Research Team?
Ying Han, MD, PhD
Principal Investigator
University of California, San Francisco
Jennifer Rose-Nussbaumer, MD
Principal Investigator
Stanford University
Thuy Doan, MD, PhD
Principal Investigator
University of California San Fransicso
Are You a Good Fit for This Trial?
This trial is for adults over 18 with medically uncontrolled glaucoma needing a Glaucoma Drainage Device (GDD) or GDD with phacoemulsification. Candidates must be suitable for GDD implantation in the ciliary sulcus and anterior chamber, able to consent, accept randomization, and attend scheduled visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo glaucoma drainage device implantation with tube placement in either the anterior chamber or ciliary sulcus
Follow-up
Participants are monitored for endothelial cell density, intraocular pressure, and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Anterior chamber (AC) tube placement
- Sulcus tube placement
Anterior chamber (AC) tube placement is already approved in United States, European Union for the following indications:
- Glaucoma
- Primary Open-Angle Glaucoma
- Mixed-Mechanism Glaucoma
- Glaucoma
- Primary Open-Angle Glaucoma
- Mixed-Mechanism Glaucoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Stanford University
Collaborator
National Eye Institute (NEI)
Collaborator
University of California, San Francisco
Collaborator