Tied Tube Trial in Glaucoma Surgery

This study is looking at a surgical technique for people with glaucoma (a condition that damages the optic nerve and can lead to vision loss) who are having an Ahmed Glaucoma Valve (AGV) implanted. Researchers want to see if delaying the flow of fluid through the AGV, by using a special stitch called a vicryl ligature, can lead to better outcomes after surgery. You could be eligible if you are at least 18 years old, have glaucoma that isn't well-controlled, and are scheduled for an AGV implant. The study will measure changes in your eye pressure (IOP) at different times over 12 months to see if the new technique is more effective. The current status of this study is unclear.

Study design
This is an observational, randomized study involving 152 participants. Participants will be randomly assigned to receive either the standard AGV implantation or the AGV implantation with the vicryl ligature.
What's involved
Your eye pressure will be measured at day one, week one, and months one, three, six, and twelve after surgery. Clinical data on glaucoma medications and post-operative complications will also be collected.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after surgery, with eye pressure measurements taken at specific intervals.

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NCT05685485

Tied Tube Trial in Glaucoma Surgery

Recruiting
Not specifiedAges 18+Observational
Washington University School of Medicine
~152 participants
Updated 2024-08-27 on ClinicalTrials.gov
What's tested:Standard ImplantationTied off Tube

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IOP Change
Measured over Months 1, 3 , 6, and 12
Glaucoma Eye
Ahmed Glaucoma Valve Implantation
1 sites across 1 states
Missouri1
  • James Liu, MD · PRINCIPAL_INVESTIGATOR · Washington University St. Louis MO

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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.
  • IOP ChangeMonths 1, 3 , 6, and 12

    Change IOP