Anterior Chamber Inflammation, Ocular Pain, Corneal Edema, Corneal Defect, Penetrating KeratoPlasty, Nuclear Cataract, Cortical Cataract, Cataract Senile
Conditions
Brief summary
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
Detailed description
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
Interventions
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.
Sponsors
Nicole Fram M.D.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Patients who received DEXTENZA insertion perioperatively.
Exclusion criteria
* Any patient who did not receive DEXTENZA insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in pain score | Assessed for 3 months after drug insertion | As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible |
| Mean change in inflammation (Cell and Flare) scores | Assessed for 3 months after drug insertion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eyes requiring additional post-operative therapy | Assessed for 3 months after drug insertion | Proportion of eyes requiring additional post-operative therapy for pain and inflammation |
| Number of patient call-backs regarding post-operative pain | Assessed for 3 months after drug insertion | Number of patient call-backs regarding post-operative pain and medication management |
| Number of pharmacy call-backs regarding post-operative medication | Assessed for 3 months after drug insertion | Number of pharmacy call-backs regarding post-operative medication management |
| Resolution of pain | Assessed for 1 months after drug insertion | Resolution of pain as assessed by aquestionnaire in post-op visits |
| Mean change in IOP | Assessed for 3 months after drug insertion | Mean change in IOP over post-op visits |
| Change in BCVA | Assessed for 3 months after drug insertion | Change in BCVA over post op visits |
| Adverse events | Assessed for 3 months after drug insertion | Incidence and severity of adverse events |
| Resolution of anterior chamber inflammation | Assessed for 3 months after drug insertion | Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits |
Countries
United States
Outcome results
None listed