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OpenTrials
Completed

NCT Number: NCT04303897

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

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.

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Key information

Conditions

Refractory Glaucoma Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boao Super Hospital /ID# 233669

Qionghai, Hainan, 571434, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN Glaucoma Stent

Device

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

Primary outcomes

  1. 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

  1. Mean decrease in IOP

    Time frame: Baseline to Month 12

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2020
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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