Tied Tube Trial in Glaucoma Surgery

Glaucoma Eye Clinical Trial

Official title:

The Effects of Temporary Tube Ligation in Ahmed Glaucoma Valve Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685485
• Other study ID #: 202206072
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: Amer Al Badwai
• Phone: 314-286-2946
• Email: aamer[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: January 31, 2025
• Est. primary completion date: December 18, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye

Intervention

Procedure:
• Standard Implantation
Traditional Ahmed plantation without vicryl ligature
• Tied off Tube
Ahmed implantation with vicryl ligature

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Glaucoma Society, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Rate	Change Hypotony, Reoperations, Significant Vision Loss	Months 1, 3, 6, and 12
Other	Surgical Case Time	Decrease surgical case time	Post op day 0
Other	Capsule Thickness as measured by anterior segment OCT	Capsule Thickness as measured by anterior segment OCT	month 6
Primary	IOP Change	Change IOP	Months 1, 3 , 6, and 12
Secondary	Medication Change	Change glaucoma medications	Months 1, 3, 6, and 12