Actively Recruiting

Age: 18Years +
All Genders
ID05685485

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

Led by Washington University School of Medicine · Updated on 2024-08-27

152

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

A

American Glaucoma Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with glaucoma who need surgery using the Ahmed FP7 glaucoma valve implant. The study aims to compare two surgical techniques to see if delaying early fluid flow through the Ahmed tube shunt improves post-operative results and reduces complications. This randomized, prospective, multi-center study takes place at several U.S. institutions and focuses on whether limiting early fluid flow reduces inflammation, scarring, and improves long-term eye pressure control. Participants will be randomly assigned to one of two groups: one receiving the standard Ahmed valve implantation without a ligature, and the other receiving implantation with a vicryl ligature to delay early flow through the tube. The study will observe differences in surgical outcomes between these two approaches. The use of the ligature is intended to reduce early fluid flow and potentially improve healing and reduce complications like the hypertensive phase or hypotony. During the study, eye pressure levels will be measured at day one, week one, and at months one, three, six, and twelve after surgery. Researchers will also track the number of glaucoma medications used and any post-operative complications. The main goal is to evaluate changes in intraocular pressure over a year and assess medication adjustments and complication rates. Participation involves regular follow-ups to monitor eye health and surgical outcomes over 12 months.

CONDITIONS

Brief Title

Tied Tube Trial in Glaucoma Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at screening
  • Inadequately controlled glaucoma or ocular hypertension
  • Planned Ahmed valve implant surgery
  • Diagnosis of primary glaucomas (open angle or angle closure), pseudoexfoliation, pigmentary, or traumatic glaucoma
  • May have previous failed trabeculectomy or other intraocular surgery
  • Primary tubes included
  • Investigators recruit consecutively all eligible patients
  • Capable and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • No light perception vision
  • Unable or unwilling to provide informed consent
  • Unavailable for regular follow-up
  • Previous cyclodestructive procedure
  • Prior scleral buckling or other external impediment to drainage device implantation
  • Presence of silicone oil in the eye
  • Vitreous in anterior chamber requiring vitrectomy
  • Uveitic glaucoma
  • Neovascular glaucoma
  • Nanophthalmos
  • Elevated episcleral venous pressure due to other pathology
  • Combined ocular surgery other than cataract surgery
  • Any eye abnormality other than glaucoma affecting tonometry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and initial recovery period

Participants undergo Ahmed glaucoma valve implant surgery using either standard implantation or tied off tube techniques, followed by immediate post-operative care.

1 surgery visit and immediate post-operative assessments

Post-operative Follow-up

Duration - 12 months

Participants are monitored for surgical outcomes, complication rates, and intraocular pressure changes after surgery.

Visits at Months 1, 3, 6, and 12

Trial Site Locations

Total: 1 location

1

Washington University

St Louis, Missouri, United States, 63108

Actively Recruiting

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Research Team

A

Amer Al Badwai

E

Eve Adcock

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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