Tied Tube Trial in Glaucoma Surgery

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve 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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma Eye; Ahmed Glaucoma Valve Implantation
• Intervention / Treatment: Procedure: Standard Implantation; Procedure: Tied off Tube

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 152

Contacts and Locations

• Study Contact: Name: Amer Al Badwai; Phone Number: 314-286-2946; Email: aamer@wustl.edu
• Study Contact Backup: Name: Eve Adcock; Phone Number: 314-273-3557; Email: adcockl@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Recruiting
      • Washington University
      • Contact: Amer Al Badwai; Phone Number: 314-286-2946; Email: aamer@wustl.edu
      • Contact: Eve Adcock, CCRC; Phone Number: 314-273-3557; Email: adcockl@wustl.edu
      • Principal Investigator: James Liu, MD
      • Sub-Investigator: Carla Siegfried, MD
      • Sub-Investigator: Erin Sieck, MD
      • Sub-Investigator: Arsham Sheybani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population will include patients where the clinical and surgical decision is to undergo an Ahmed glaucoma valve implantation. Participants will be identified by the ophthalmologist overseeing their glaucoma care.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Implantation	Procedure: Standard Implantation; Traditional Ahmed plantation without vicryl ligature
Tied off Tube	Procedure: Tied off Tube; Ahmed implantation with vicryl ligature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP Change	Change IOP	Months 1, 3 , 6, and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Change	Change glaucoma medications	Months 1, 3, 6, and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Case Time	Decrease surgical case time	Post op day 0
Capsule Thickness as measured by anterior segment OCT	Capsule Thickness as measured by anterior segment OCT	month 6
Complication Rate	Change Hypotony, Reoperations, Significant Vision Loss	Months 1, 3, 6, and 12

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Pittsburgh; American Glaucoma Society
• Investigators: Principal Investigator: James Liu, MD, Washington University St. Louis MO

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): December 18, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 202206072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No