Sinus Stents with Mometasone and Diminished Visual Acuity

Project Title Sinus Stents with Mometasone and Diminished Visual Acuity
Date Posted
Thursday, September 12, 2019
Project ID
cder_mpl1r_wp062, cder_mpl1r_wp061
Status
Complete
Deliverables
Related Links
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. 

Medical Product
intranasal steroid
mometasone
oral steroid
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