Tied Tube Trial in Glaucoma Surgery
The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amer Al Badwai
- Phone Number: 314-286-2946
- Email: aamer@wustl.edu
Study Contact Backup
- Name: Eve Adcock
- Phone Number: 314-273-3557
- Email: adcockl@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63108
- Recruiting
- Washington University
-
Contact:
- Amer Al Badwai
- Phone Number: 314-286-2946
- Email: aamer@wustl.edu
-
Contact:
- Eve Adcock, CCRC
- Phone Number: 314-273-3557
- Email: adcockl@wustl.edu
-
Principal Investigator:
- James Liu, MD
-
Sub-Investigator:
- Carla Siegfried, MD
-
Sub-Investigator:
- Erin Sieck, MD
-
Sub-Investigator:
- Arsham Sheybani, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 NLP vision
- Subjects unable/unwilling to provide informed consent
- Unavailable for regular follow up
- Previous cyclodestructive procedure
- Prior scleral buckling procedure or other external impediment to drainage device implantation
- Presence of silicone oil
- Vitreous in the anterior chamber sufficient to require a vitrectomy
- Uveitic glaucoma
- Neovascular glaucoma
- Nanophthalmos
- Patients with pathology that may cause elevated episcleral venous pressure
- Procedure combined with ocular surgery other than cataract surgery (i.e. combined tube-cataract surgery is okay)
- Any abnormality other than glaucoma in the study eye that could affect tonometry.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Standard Implantation
|
Traditional Ahmed plantation without vicryl ligature
|
|
Tied off Tube
|
Ahmed implantation with vicryl ligature
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IOP Change
Time Frame: Months 1, 3 , 6, and 12
|
Change IOP
|
Months 1, 3 , 6, and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Change
Time Frame: Months 1, 3, 6, and 12
|
Change glaucoma medications
|
Months 1, 3, 6, and 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Case Time
Time Frame: Post op day 0
|
Decrease surgical case time
|
Post op day 0
|
|
Capsule Thickness as measured by anterior segment OCT
Time Frame: month 6
|
Capsule Thickness as measured by anterior segment OCT
|
month 6
|
|
Complication Rate
Time Frame: Months 1, 3, 6, and 12
|
Change Hypotony, Reoperations, Significant Vision Loss
|
Months 1, 3, 6, and 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: James Liu, MD, Washington University St. Louis MO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202206072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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