TabsDetailsBasic DetailsDate Posted: Thursday, September 12, 2019Status: CompleteMedical Product: intranasal steroid, mometasone, oral steroid, sinus stentHealth Outcome(s): blindnesscataract surgerycataractsdiminished visual acuityglaucomaDescription: 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. Read More Deliverables (2)Sentinel Modular Program Report: Utilization of Sinus Stents with Mometasone, Report 1Sentinel Modular Program Report: Utilization of Sinus Stents with Mometasone, Report 2Additional InformationAdditional DetailsFDA Center: CDERTime Period: August 1, 2011 – May 31, 2017Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: All individualsData Sources: Sentinel Distributed Database (SDD)Related Links: Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis