The Baerveldt Versus ClearPath Comparison Study

Duke University

Status

Completed

Conditions

Glaucoma

Treatments

Device: Baerveldt 350 implant

Device: Ahmed ClearPath 350 implant

Study type

Interventional

Funder types

Other

Identifiers

NCT04468633

PRO00105781

Details and patient eligibility

About

This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.

Enrollment

76 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men or women with age at screening ≥ 18 years and ≤ 90 years
Inadequately controlled glaucoma
Valve-less aqueous shunt as the planned surgical procedure
Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
Primary tubes included
Investigators to recruit consecutively all eligible patients from their clinics.
Superotemporal or inferonasal placement of the tube
Capable and willing to provide consent

Exclusion criteria

NLP
Unable/unwilling to provide informed consent
Unavailable for regular follow up
Previous cyclodestructive procedure
Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
Presence of silicone oil
Vitreous in the anterior chamber sufficient to require a vitrectomy
Uveitic glaucoma
Neovascular glaucoma
Nanophthalmos
Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
Procedure combined with other surgery
Any abnormality other than glaucoma in the study eye that could affect tonometry.