TabsDetailsBasic DetailsDate Posted: Wednesday, August 5, 2020Status: CompleteHealth Outcome(s): cataractsdiminished visual acuityglaucomanasal septal perforationDescription: In this analysis we examined ocular events and nasal septal perforations in single and repeat mometasone sinus implant users with nasal polyposis in the Sentinel Distributed Database (SDD). This request includes three reports:Report 1: We examined glaucoma, cataracts, diminished visual acuity, and nasal septal perforations among mometasone sinus implant users with nasal polyposis. This request was distributed to Data Partners on November 12, 2019.Report 2: We examined glaucoma and cataracts among mometasone sinus implant users with nasal polyposis, with an updated mometasone sinus implant definition and additional sensitivity analyses of the incidence criteria. This request was distributed to Data Partners on March 12, 2020.Report 3: We examined diminished visual acuity and nasal septal perforations among mometasone sinus implant users with nasal polyposis, with an updated mometasone sinus implant definition and additional sensitivity analyses of the incidence criteria. This request was distributed to Data Partners on March 12, 2020.These reports contain data from 16 Data Partners contributing to the SDD. Data from January 1, 2016 to April 30, 2019 were included in Report 1; Data from January 1, 2016 to September 30, 2019 were included in Reports 2 and 3.The analytic packages associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation. Read More Deliverables (4)Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis, Report 1Glaucoma and Cataracts following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis, Report 2Diminished Visual Acuity and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis, Report 3Sentinel Analytic Packages: Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2016 - September 30, 2019Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Individuals 18 years of age and olderData Sources: Sentinel Distributed Database (SDD)Related Links: Sinus Stents with Mometasone and Diminished Visual AcuityGlaucoma Algorithm Defined in "Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis"Cataracts Algorithm Defined in "Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis"Diminished Visual Acuity Algorithm Defined in "Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis"Nasal Septal Perforation Algorithm Defined in "Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis"2020 ICPE Poster: Incidence of Ocular Adverse Events Associated with Mometasone Implants among Patients with Nasal Polyposis