Skip to main content

Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
mometasone furoate sinus implant
Health Outcome(s)
cataracts
diminished visual acuity
glaucoma
nasal septal perforation
ocular hypertension
Description

In this analysis, we estimated the incidence rates of ocular adverse events (cataract, glaucoma, ocular hypertension, and diminished visual acuity) and nasal septal perforation among individuals with new use of a 1350 mcg mometasone furoate nasal stent implant (brand name: Sinuva) and among individuals with new use of a 370 mcg mometasone furoate nasal stent implant (brand name: Propel) in the Sentinel Distributed Database (SDD). We also estimated the incidence rates of glaucoma and cataract among individuals with evidence of repeat use of the 1350 mcg mometasone furoate nasal stent implant (brand name: Sinuva).

We distributed this query to 14 Sentinel Data Partners on July 22, 2024. The study period includes data from December 1, 2017 through January 31, 2024.

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.

Deliverables (2)
Sentinel Modular Program Report: Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis Sentinel Analytic Package: Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
December 1, 2017 - January 31, 2024
Analysis Type
Descriptive
Population / Cohort
Individuals 18 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sinuva (Mometasone Furoate Sinus Implant) & Cataracts, Diminished Visual Acuity, Glaucoma, Nasal Septal Perforation, and Ocular Hypertension
Ocular Hypertension Algorithm Defined in "Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis"
Nasal Septal Perforation Algorithm Defined in "Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis"
Glaucoma Algorithm Defined in "Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis"
Diminished Visual Acuity Algorithm Defined in "Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis"
Cataracts Algorithm Defined in "Cataracts, Glaucoma, Ocular Hypertension, Diminished Visual Acuity, and Nasal Septal Perforation Following Sinuva and Propel (Mometasone Furoate Sinus Implants) Use: A Descriptive Analysis"