A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Anterior Chamber Inflammation, Ocular Pain, Corneal Edema, Corneal Defect, Penetrating KeratoPlasty, Nuclear Cataract, Cortical Cataract, Cataract Senile

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Patients who received DEXTENZA insertion perioperatively. Exclusion Criteria: Any patient who did not receive DEXTENZA insertion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dextenza recepient<br>A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* 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.<br>* Other names: Dexamethasone 0.4mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Assessed for 3 months after drug insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of pain | Resolution of pain as assessed by aquestionnaire in post-op visits | 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 | 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 | 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 | 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 | Assessed for 3 months after drug insertion | 
| Adverse events | Incidence and severity of adverse events | Assessed for 3 months after drug insertion | 
| Mean change in IOP | Mean change in IOP over post-op visits | Assessed for 3 months after drug insertion | 
| Change in BCVA | Change in BCVA over post op visits | Assessed for 3 months after drug insertion |