Recruiting

Tied Tube Trial

Sponsor:

Washington University School of Medicine

Code:

NCT05685485

Conditions

Glaucoma Eye

Ahmed Glaucoma Valve Implantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Implantation

Tied off Tube

Study Details

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 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

Study ID

NCT05685485

Start date

Oct 18, 2022

Status verified date

Aug, 2024

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Dec 18, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

152 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard Implantation

Standard Implantation

Tied off Tube

Tied off Tube

Interventions

Standard Implantation

Traditional Ahmed plantation without vicryl ligature

Tied off Tube

Ahmed implantation with vicryl ligature

Primary outcome measure

  • IOP Change [ Time Frame: Months 1, 3 , 6, and 12 ]

Central Contacts and Locations

Central contacts

Amer Al Badwai

314-286-2946aamer@wustl.edu

Eve Adcock

314-273-3557adcockl@wustl.edu

Locations

Washington University

Recruiting

Saint Louis, Missouri, United States, 63108

Contacts

Amer Al Badwai

314-286-2946aamer@wustl.edu

Eve Adcock, CCRC

314-273-3557adcockl@wustl.edu

Principal Investigator:

James Liu, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2024-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.