Actively Recruiting
The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery
Led by Washington University School of Medicine · Updated on 2024-08-27
152
Participants Needed
1
Research Sites
6 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 studying patients with glaucoma who need surgery using the Ahmed FP7 glaucoma valve implant. The study aims to compare two surgical techniques to see if delaying early fluid flow through the Ahmed tube shunt improves post-operative results and reduces complications. This randomized, prospective, multi-center study takes place at several U.S. institutions and focuses on whether limiting early fluid flow reduces inflammation, scarring, and improves long-term eye pressure control. Participants will be randomly assigned to one of two groups: one receiving the standard Ahmed valve implantation without a ligature, and the other receiving implantation with a vicryl ligature to delay early flow through the tube. The study will observe differences in surgical outcomes between these two approaches. The use of the ligature is intended to reduce early fluid flow and potentially improve healing and reduce complications like the hypertensive phase or hypotony. During the study, eye pressure levels will be measured at day one, week one, and at months one, three, six, and twelve after surgery. Researchers will also track the number of glaucoma medications used and any post-operative complications. The main goal is to evaluate changes in intraocular pressure over a year and assess medication adjustments and complication rates. Participation involves regular follow-ups to monitor eye health and surgical outcomes over 12 months.
CONDITIONS
Brief Title
Tied Tube Trial in Glaucoma Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Inadequately controlled glaucoma or ocular hypertension
- Planned Ahmed valve implant surgery
- Diagnosis of primary glaucomas (open angle or angle closure), pseudoexfoliation, pigmentary, or traumatic glaucoma
- May have previous failed trabeculectomy or other intraocular surgery
- Primary tubes included
- Investigators recruit consecutively all eligible patients
- Capable and willing to provide informed consent
You will not qualify if you...
- No light perception vision
- 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 in the eye
- Vitreous in anterior chamber requiring vitrectomy
- Uveitic glaucoma
- Neovascular glaucoma
- Nanophthalmos
- Elevated episcleral venous pressure due to other pathology
- Combined ocular surgery other than cataract surgery
- Any eye abnormality other than glaucoma affecting tonometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and initial recovery period
Participants undergo Ahmed glaucoma valve implant surgery using either standard implantation or tied off tube techniques, followed by immediate post-operative care.
1 surgery visit and immediate post-operative assessments
Duration - 12 months
Participants are monitored for surgical outcomes, complication rates, and intraocular pressure changes after surgery.
Visits at Months 1, 3, 6, and 12
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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