Tied Tube Trial in Glaucoma Surgery

Description

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 investigator will conduct a, randomized prospective, multi-centered study with collaborators at WashU in St. Louis, Duke University, Indiana University and the University of Pittsburgh. Participants will be randomized to have an AGV placement with tube ligation (no-early flow) and without ligation (allowing for early flow). IOP will be measured at day one, week one, and months, one, three six, and twelve. Additionally, clinical data regarding number of glaucoma medications, and complications post-operative complications will also be collected.

Conditions

Glaucoma Eye, Ahmed Glaucoma Valve Implantation

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Study Overview

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Study Details

Study overview

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 investigator will conduct a, randomized prospective, multi-centered study with collaborators at WashU in St. Louis, Duke University, Indiana University and the University of Pittsburgh. Participants will be randomized to have an AGV placement with tube ligation (no-early flow) and without ligation (allowing for early flow). IOP will be measured at day one, week one, and months, one, three six, and twelve. Additionally, clinical data regarding number of glaucoma medications, and complications post-operative complications will also be collected.

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

Tied Tube Trial in Glaucoma Surgery

Condition
Glaucoma Eye
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

James Liu, MD, PRINCIPAL_INVESTIGATOR, Washington University St. Louis MO

Study Record Dates

2025-01-31