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

Study Identifier
1924-801-007
CT.gov Identifier
NCT04303897
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Glaucoma - Other
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Boao Super Hospital /ID# 233669
    Qionghai, Hainan, China, 571434
    Status
    Not applicable