Actively Recruiting
Tied Tube Trial in Glaucoma Surgery
Led by Washington University School of Medicine · Updated on 2024-08-27
152
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
A
American Glaucoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to assess whether delaying early flow through the Ahmed tube shunt may improve the post-operative surgical outcomes and provide a more predictable outcome. To assess this the investigator will conduct a, randomized prospective, multi-centered study with collaborators at WashU in St. Louis, Duke University, Indiana University and the University of Pittsburgh. Participants will be randomized to have an AGV placement with tube ligation (no-early flow) and without ligation (allowing for early flow). IOP will be measured at day one, week one, and months, one, three six, and twelve. Additionally, clinical data regarding number of glaucoma medications, and complications post-operative complications will also be collected.
CONDITIONS
Official Title
Tied Tube Trial in Glaucoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 years or older at screening
- Inadequately controlled glaucoma or ocular hypertension
- Planned surgical procedure is Ahmed valve implant
- Patients with primary glaucomas (Primary Open Angle or Primary Angle Closure) or pseudoexfoliation, pigmentary, or traumatic glaucoma, with or without previous failed trabeculectomy or other intraocular surgery
- Primary tubes included
- Investigators to recruit all eligible patients consecutively from their clinics
- Capable and willing to provide consent
You will not qualify if you...
- Subjects with no light perception vision
- Subjects unable or unwilling to provide informed consent
- Unavailable for regular follow-up
- Previous cyclodestructive procedure
- Prior scleral buckling or other external impediment to drainage device implantation
- Presence of silicone oil
- Vitreous in the anterior chamber requiring vitrectomy
- Uveitic glaucoma
- Neovascular glaucoma
- Nanophthalmos
- Patients with conditions causing elevated episcleral venous pressure
- Procedures combined with ocular surgery other than cataract surgery (combined tube-cataract surgery allowed)
- Any abnormality other than glaucoma in the study eye affecting tonometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University
St Louis, Missouri, United States, 63108
Actively Recruiting
Research Team
A
Amer Al Badwai
CONTACT
E
Eve Adcock
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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