Tied Tube Trial in Glaucoma Surgery

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jan 5, 2023

Keywords

ClinConnect Summary

The Tied Tube Trial is a clinical study designed to find out if delaying the flow of fluid through a specific type of glaucoma device called the Ahmed Glaucoma Valve (AGV) can lead to better results after surgery. This study involves several medical centers, including those in St. Louis, Duke University, Indiana University, and the University of Pittsburgh. Participants in the trial will be assigned by chance to one of two groups: one group will have the AGV implanted with a temporary blockage to prevent early fluid flow, while the other group will have it implanted without the blockage, allowing fluid to flow right away. Researchers will monitor eye pressure and collect information on medications and any complications over the first year after surgery.

To be eligible for this trial, participants must be at least 18 years old, have glaucoma that is not well controlled, and be scheduled for an AGV operation. They should also be willing to participate and provide consent. However, individuals with certain eye conditions or previous surgeries that may complicate the procedure will not be able to join. If you participate, you can expect regular check-ups to track your eye pressure and overall progress after the surgery. This study aims to improve surgical outcomes for glaucoma patients and provide more predictable results in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.