Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis

Project Title Glaucoma, Cataracts, Diminished Visual Acuity, and Nasal Septal Perforation following Mometasone Sinus Implant Use in Patients with Nasal Polyposis: A Descriptive Analysis
Date Posted
Wednesday, August 5, 2020
Project ID
cder_mpl1r_wp157, cder_mpl1r_wp172, cder_mpl1r_wp176
Status
Complete
Deliverables
Related Links
Description

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.

Health Outcome
cataracts
diminished visual acuity
glaucoma
nasal septal perforation
Population / Cohort
Individuals 18 years of age and older
Time Period
January 1, 2016 - September 30, 2019
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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