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

Completed
Conditions
Refractory Glaucoma
Interventions
Device: XEN Glaucoma Stent
Registration Number
NCT04303897
Lead Sponsor
Allergan
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
XEN Glaucoma StentXEN Glaucoma Stent-
Primary Outcome Measures
NameTimeMethod
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 baselineBaseline to Month 12
Secondary Outcome Measures
NameTimeMethod
Mean decrease in IOPBaseline to Month 12

Trial Locations

Locations (1)

Boao Super Hospital /ID# 233669

🇨🇳

Qionghai, Hainan, China

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