Actively Recruiting
The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery A Randomized Study Comparing Standard and Tied Tube Implantation for Glaucoma
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
Researchers are evaluating whether delaying early fluid flow through the Ahmed glaucoma valve implant can improve surgical outcomes and provide more predictable results for patients with glaucoma or ocular hypertension. This study is a randomized, prospective, multi-center trial involving collaborators at WashU in St. Louis, Duke University, Indiana University, and the University of Pittsburgh. The goal is to compare outcomes between two surgical techniques using the Ahmed FP7 glaucoma valve implant, focusing on whether limiting early aqueous flow reduces complications like hypertensive phase, capsular fibrosis, and improves long-term intraocular pressure (IOP) control. Participants will be randomly assigned to one of two groups: traditional Ahmed valve implantation without a vicryl ligature (allowing early fluid flow) or Ahmed implantation with a vicryl ligature to delay early flow. This ligature technique aims to reduce inflammation and fibrosis by temporarily blocking fluid flow. IOP will be measured at day 1, week 1, and months 1, 3, 6, and 12 after surgery. The study will also collect clinical data on glaucoma medications used and any post-operative complications. During the study, participants will undergo regular assessments including IOP measurements and monitoring for complications. Researchers will track glaucoma medication use and any adverse events over a 12-month period. The primary outcome is the change in IOP at various time points after surgery. Participants will attend scheduled follow-up visits to help determine which surgical method provides better long-term control of eye pressure and fewer complications.
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
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Trial Site Locations
Total: 1 location
1
Washington University
St Louis, Missouri, United States, 63108
Actively Recruiting
Research Team
A
Amer Al Badwai
E
Eve Adcock
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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