Tied Tube Trial in Glaucoma Surgery

ConditionsGlaucoma Eye Ahmed Glaucoma Valve Implantation

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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Standard Implantation
Procedure/Surgery
Traditional Ahmed plantation without vicryl ligature
Tied off Tube
Procedure/Surgery
Ahmed implantation with vicryl ligature

Treatment groups

152 Participants

are divided into 2 treatment groups

Group A: Standard Implantation1 intervention

Group B: Tied off Tube1 intervention

Trial outcomes

Primary outcomes

IOP Change

Change IOP

Time frame

Months 1, 3 , 6, and 12

Secondary outcomes

Medication Change

Change glaucoma medications

Time frame

Months 1, 3, 6, and 12

Other outcomes

Complication Rate

Change Hypotony, Reoperations, Significant Vision Loss

Time frame

Months 1, 3, 6, and 12

Surgical Case Time

Decrease surgical case time

Time frame

Post op day 0

Capsule Thickness as measured by anterior segment OCT

Time frame

month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

American Glaucoma Society

Collaborator

University of Pittsburgh

Collaborator

Source ClinicalTrials.gov

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