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

Allergan59 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Refractory Glaucoma

Interventions

XEN Glaucoma StentDEVICE

Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Boao Super Hospital /ID# 233669

Qionghai, Hainan, China

Outcomes

Primary Outcomes

Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline

Time frame: Baseline to Month 12

Secondary Outcomes

Mean decrease in IOP

Time frame: Baseline to Month 12

Data from ClinicalTrials.gov

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