A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal transplant or Cataract surgery
A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid Prior to or Following Corneal transplant or Cataract surgery
Study Type
OBSERVATIONAL
Enrollment
25
DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
Advanced Vision Care
Los Angeles, California, United States
Mean change in pain score
As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible
Time frame: Assessed for 3 months after drug insertion
Mean change in inflammation (Cell and Flare) scores
As measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1
Time frame: Assessed for 3 months after drug insertion
Resolution of pain
Resolution of pain as assessed by aquestionnaire in post-op visits
Time frame: Assessed for 1 months after drug insertion
Resolution of anterior chamber inflammation
Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits
Time frame: Assessed for 3 months after drug insertion
Proportion of eyes requiring additional post-operative therapy
Proportion of eyes requiring additional post-operative therapy for pain and inflammation
Time frame: Assessed for 3 months after drug insertion
Number of patient call-backs regarding post-operative pain
Number of patient call-backs regarding post-operative pain and medication management
Time frame: Assessed for 3 months after drug insertion
Number of pharmacy call-backs regarding post-operative medication
Number of pharmacy call-backs regarding post-operative medication management
Time frame: Assessed for 3 months after drug insertion
Adverse events
Incidence and severity of adverse events
Time frame: Assessed for 3 months after drug insertion
Mean change in IOP
Mean change in IOP over post-op visits
Time frame: Assessed for 3 months after drug insertion
Change in BCVA
Change in BCVA over post op visits
Time frame: Assessed for 3 months after drug insertion
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