Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma

Allergan

Status: Completed

Conditions: Refractory Glaucoma

Treatments: Device: XEN Glaucoma Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT04303897

1924-801-007

Details and patient eligibility

About

Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy

Exclusion criteria

• Angle closure glaucoma where angle has not been surgically opened
• Previous glaucoma shunt/valve in the target quadrant
• Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
• Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
• Active iris neovascularization or neovascularization of the iris within six months of the surgical date
• Anterior chamber intraocular lens
• Presence of intraocular silicone oil
• Vitreous present in the anterior chamber

Trial design

59 participants in 1 patient group

XEN Glaucoma Stent

Treatment:

Device: XEN Glaucoma Stent