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Glaucoma Eye
+1

Tied Tube Trial in Glaucoma Surgery

Sponsored by Washington University School of Medicine

About this trial

Last updated 2 years ago

Study ID

202206072

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 6 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status

Recruiting