Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
NCT ID: NCT05924477
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
226 participants
INTERVENTIONAL
2023-07-11
2027-12-31
Brief Summary
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Detailed Description
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The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up.
Patients will be randomized to 2 tube locations for GDD implantation:
* Tube placed in the AC
* Tube placed in ciliary sulcus
* Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sulcus tube placement
Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus
Sulcus tube placement
GDD implantation surgery with tube placement in the ciliary sulcus
Anterior chamber (AC) tube placement
Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber
Anterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber
Interventions
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Sulcus tube placement
GDD implantation surgery with tube placement in the ciliary sulcus
Anterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber
Eligibility Criteria
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Inclusion Criteria
* Candidate for GDD implantation for ciliary sulcus and AC tube
* Age greater than or equal to 18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
University of California, San Francisco
OTHER
Stanford University
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Ying Han, MD, PhD
Role: STUDY_CHAIR
University of California, San Francisco
Jennifer Rose-Nussbaumer, MD
Role: STUDY_DIRECTOR
Stanford University
Thuy Doan, MD, PhD
Role: STUDY_DIRECTOR
University of California San Fransicso
Locations
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University of California San Francisco
San Francisco, California, United States
Diablo Eye Associates
Walnut Creek, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
University of Buffalo/State University of New York
Buffalo, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Prism Eye Institute, University of Toronto
Toronto, , Canada
Countries
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Central Contacts
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Facility Contacts
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Ying Han, MD, PhD
Role: primary
Yen Cheng Hsia, MD
Role: primary
Steven Gedde, MD
Role: primary
Pradeep Yammanuru Ramulu, MD, PhD
Role: primary
Teresa Chen, MD
Role: primary
Asher Weiner, MD
Role: primary
Donald Budenz, MD
Role: primary
Iqbal Ike Ahmed, MD, PhD
Role: primary
Other Identifiers
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853474
Identifier Type: -
Identifier Source: org_study_id
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