The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery
Washington University School of Medicine
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.
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.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 N…
Interventions
- ProcedureStandard Implantation
Traditional Ahmed plantation without vicryl ligature
- ProcedureTied off Tube
Ahmed implantation with vicryl ligature
Location
- Washington UniversitySt Louis, Missouri