Trial comparing treatments for Glaucoma
Official title Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
ClinicalTrials.gov ID: NCT05924477
What this study is testing
- What it's testing
- The trial aims to find out whether putting the device in the front part of the eye or in the space behind the iris results in less loss of eye cells.
- Who it's for
- It is looking for people who have glaucoma and may need a drainage device implanted.
- What's involved
- Participants will have the device implanted in one of two locations and will be followed up with eye exams and tests to monitor cell health.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Walnut Creek, California, United States
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
- Chapel Hill, North Carolina, United States
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Walnut Creek, California, United States; Miami, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Buffalo, New York, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.