RECRUITING

Tied Tube Trial in Glaucoma Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

Quick Facts

Study Start:2022-10-18
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05685485

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with age at screening ≥ 18 years
  2. * Inadequately controlled glaucoma or ocular hypertension
  3. * Ahmed valve implant as the planned surgical procedure
  4. * 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.
  5. * Primary tubes included
  6. * Investigators to recruit consecutively all eligible patients from their clinics.
  7. * Capable and willing to provide consent
  1. * Subjects with NLP vision
  2. * Subjects unable/unwilling to provide informed consent
  3. * Unavailable for regular follow up
  4. * Previous cyclodestructive procedure
  5. * Prior scleral buckling procedure or other external impediment to drainage device implantation
  6. * Presence of silicone oil
  7. * Vitreous in the anterior chamber sufficient to require a vitrectomy
  8. * Uveitic glaucoma
  9. * Neovascular glaucoma
  10. * Nanophthalmos
  11. * Patients with pathology that may cause elevated episcleral venous pressure
  12. * Procedure combined with ocular surgery other than cataract surgery (i.e. combined tube-cataract surgery is okay)
  13. * Any abnormality other than glaucoma in the study eye that could affect tonometry.

Contacts and Locations

Study Contact

Amer Al Badwai
CONTACT
314-286-2946
aamer@wustl.edu
Eve Adcock
CONTACT
314-273-3557
adcockl@wustl.edu

Principal Investigator

James Liu, MD
PRINCIPAL_INVESTIGATOR
Washington University St. Louis MO

Study Locations (Sites)

Washington University
Saint Louis, Missouri, 63108
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-18
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2022-10-18
Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Glaucoma Eye
  • Ahmed Glaucoma Valve Implantation