Tied Tube Trial in Glaucoma Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Subjects with NLP vision
Subjects unable/unwilling to provide informed consent
Unavailable for regular follow up
Previous cyclodestructive procedure
Trial design
Treatments tested in this trial
- Standard Implantation
- Tied off Tube
Treatment groups
152 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
American Glaucoma Society
Collaborator
University of Pittsburgh
Collaborator
Source ClinicalTrials.gov