Sinus Stents with Mometasone and Diminished Visual Acuity

Project Title Sinus Stents with Mometasone and Diminished Visual Acuity
Date Posted
Monday, February 5, 2018
Project ID
cder_mpl1r_wp061
Status
Complete
Deliverables
Related Links
Description

The goal of this query was to examine the association between stent implants, intranasal steroids, oral steroids, and sinus surgery and subsequent development of diminished visual acuity, glaucoma, cataracts, or blindness in the Sentinel Distributed Database (SDD). Data from August 1, 2011 to May 31, 2017 from 16 Data Partners contributing to the SDD were included in this report. This request was distributed on October 27, 2017. 

Medical Product
mometasone
sinus stent
Health Outcome
blindness
cataract surgery
cataracts
diminished visual acuity
glaucoma
Population / Cohort
All individuals
Time Period
August 1, 2011 – May 31, 2017
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER