NCT05685485

Tied Tube Trial in Glaucoma Surgery

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

• Glaucoma Eye
• Ahmed Glaucoma Valve Implantation

Interventions

Type	Name	Description
PROCEDURE	Standard Implantation	Traditional Ahmed plantation without vicryl ligature
PROCEDURE	Tied off Tube	Ahmed implantation with vicryl ligature

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-12-18
• Completion: 2025-01-31
• First posted: 2023-01-17
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States