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NCT Number: NCT05685485

Tied Tube Trial in Glaucoma Surgery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University

St Louis, Missouri, 63108, United States

Location status: Recruiting

Location contact

Amer Al Badwai

CONTACT

[email protected]

314-286-2946

Arsham Sheybani, MD

SUB_INVESTIGATOR

Carla Siegfried, MD

SUB_INVESTIGATOR

Erin Sieck, MD

SUB_INVESTIGATOR

Eve Adcock, CCRC

CONTACT

[email protected]

314-273-3557

James Liu, MD

PRINCIPAL_INVESTIGATOR

About this study

The purpose of this study is to compare the post-operative surgical outcomes and complication rates in patients with different surgical techniques in the Ahmed FP7 glaucoma valve implant (New World Medical, Inc., Rancho Cucamonga, CA). In particular, the investigator wishes to assess whether delaying early aqueous flow by using a vicryl ligature (as done in most non-valved glaucoma drainage device implantation) will reduce the hypertensive phase, reduce early encapsulation, and optimize healing dynamics to allow for improved long term IOP results compared to standard implantation techniques.

Aggressive early aqueous flow may introduce inflammatory mediators that may increase fibrosis during wound healing. Furthermore, mechanical compression of the tissue surrounding the plate may further lead to a denser capsule and limit aqueous diffusion through Tenon's and conjunctiva. For these reasons, the investigator postulate's that the limitation of early aqueous flow through the Ahmed valve will reduce the rates of hypertensive phase, lead to a thinner and less encapsulated bleb, reduce complication rates such as hypotony, and lead to overall improvement in long-term IOP reduction.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Implantation

Procedure

Traditional Ahmed plantation without vicryl ligature

Tied off Tube

Procedure

Ahmed implantation with vicryl ligature

Primary outcomes

  1. IOP Change

    Time frame: Months 1, 3 , 6, and 12

    Change IOP

Secondary outcomes

  1. Medication Change

    Time frame: Months 1, 3, 6, and 12

    Change glaucoma medications

Other outcomes

  1. Complication Rate

    Time frame: Months 1, 3, 6, and 12

    Change Hypotony, Reoperations, Significant Vision Loss

  2. Surgical Case Time

    Time frame: Post op day 0

    Decrease surgical case time

  3. Capsule Thickness as measured by anterior segment OCT

    Time frame: month 6

    Capsule Thickness as measured by anterior segment OCT

Study contacts

Contact information is provided by the study sponsor or research team.

Amer Al Badwai

CONTACT

[email protected]

314-286-2946

Eve Adcock

CONTACT

[email protected]

314-273-3557

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Glaucoma Society
  • University of Pittsburgh

Registry information

Official study title

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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