Status:
RECRUITING
Tied Tube Trial in Glaucoma Surgery
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
American Glaucoma Society
University of Pittsburgh
Conditions:
Glaucoma Eye
Ahmed Glaucoma Valve Implantation
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
The purpose of this study is to compare the post-operative surgical outcomes and complication rates in patients with different surgical techniques in the Ahmed FP7 glaucoma valve implant (New World Me...
Eligibility Criteria
Inclusion
- Subjects with age at screening ≥ 18 years
- Inadequately controlled glaucoma or ocular hypertension
- Ahmed valve implant as the planned surgical procedure
- Patients with primary glaucomas (Primary Open Angle Glaucoma or Primary Angle Closure Glaucoma) or pseudoexfoliation, pigmentary and traumatic glaucoma with or without a previous failed trabeculectomy or other intraocular surgery.
- Primary tubes included
- Investigators to recruit consecutively all eligible patients from their clinics.
- Capable and willing to provide consent
Exclusion
- Subjects with NLP vision
- Subjects unable/unwilling to provide informed consent
- Unavailable for regular follow up
- Previous cyclodestructive procedure
- Prior scleral buckling procedure or other external impediment to drainage device implantation
- Presence of silicone oil
- Vitreous in the anterior chamber sufficient to require a vitrectomy
- Uveitic glaucoma
- Neovascular glaucoma
- Nanophthalmos
- Patients with pathology that may cause elevated episcleral venous pressure
- Procedure combined with ocular surgery other than cataract surgery (i.e. combined tube-cataract surgery is okay)
- Any abnormality other than glaucoma in the study eye that could affect tonometry.
Key Trial Info
Start Date :
October 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05685485
Start Date
October 18 2022
End Date
January 31 2025
Last Update
August 27 2024
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63108