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Sinus Stents with Mometasone and Diminished Visual Acuity

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    intranasal steroid
    mometasone
    oral steroid
    sinus stent
    Health Outcome(s)
    blindness
    cataract surgery
    cataracts
    diminished visual acuity
    glaucoma
    Description

    The goal of this request was to explore the association between sinus stent implants with mometasone and subsequent development of diminished visual acuity in the Sentinel Distributed Database (SDD). This request contains two reports:

    • Report 1 (cder_mpl1r_wp062) examined drug utilization of oral and intranasal steroids in the SDD, and was used to characterize use of oral and intranasal steroids in Report 2. This request was distributed to Data Partners on October 11, 2017.
    • Report 2 (cder_mpl1r_wp061) examined the association between stent implants, intranasal steroids, oral steroids, and sinus surgery and subsequent development of diminished visual acuity, glaucoma, cataracts, or blindness. This request was distributed to Data Partners on October 27, 2017. 

    Data from August 1, 2011 to May 31, 2017 from 16 Data Partners contributing to the SDD were included in these reports. 

    Additional Details
    FDA Center
    CDER
    Time Period
    August 1, 2011 – May 31, 2017
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)