NCT05685485

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

January 5, 2023

Last Update Submit

August 26, 2024

Conditions

Glaucoma EyeAhmed Glaucoma Valve Implantation

Outcome Measures

Primary Outcomes (1)

  • IOP Change

    Change IOP

    Months 1, 3 , 6, and 12

Secondary Outcomes (1)

  • Medication Change

    Months 1, 3, 6, and 12

Other Outcomes (3)

  • Complication Rate

    Months 1, 3, 6, and 12

  • Surgical Case Time

    Post op day 0

  • Capsule Thickness as measured by anterior segment OCT

    month 6

Study Arms (2)

Standard Implantation

Standard Implantation

Procedure: Standard Implantation

Tied off Tube

Tied off Tube

Procedure: Tied off Tube

Interventions

Standard ImplantationPROCEDURE

Traditional Ahmed plantation without vicryl ligature

Standard Implantation
Tied off TubePROCEDURE

Ahmed implantation with vicryl ligature

Tied off Tube

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

RECRUITING

Study Officials

  • James Liu, MD

    Washington University St. Louis MO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amer Al Badwai

CONTACT

314-286-2946aamer@wustl.edu

Eve Adcock

CONTACT

314-273-3557adcockl@wustl.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

October 18, 2022

Primary Completion

December 18, 2024

Study Completion

January 31, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)