Tied Tube Trial in Glaucoma Surgery

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05685485
Status
Recruiting
Apply to this trial

Conditions

  • Ahmed Glaucoma Valve Implantation
  • Glaucoma Eye

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Implantation — PROCEDURE
    Traditional Ahmed plantation without vicryl ligature
  • Tied off Tube — PROCEDURE
    Ahmed implantation with vicryl ligature

Study Details

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.

Key Dates

Start date
Oct 18, 2022
Status verified
Aug 2024
Primary completion
Dec 18, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
152 participants (estimated)

Arms

  • Arm: Standard Implantation
    Standard Implantation
  • Arm: Tied off Tube
    Tied off Tube

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63108
Amer Al Badwai
[email protected]
314-286-2946
Eve Adcock, CCRC
[email protected]
314-273-3557
James Liu, MD (PRINCIPAL_INVESTIGATOR)
Carla Siegfried, MD (SUB_INVESTIGATOR)
Erin Sieck, MD (SUB_INVESTIGATOR)
Arsham Sheybani, MD (SUB_INVESTIGATOR)

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Washington University· St Louis, MO