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

Completed

• Conditions: Corneal Defect; Cataract Senile; Anterior Chamber Inflammation; Ocular Pain; Corneal Edema; Nuclear Cataract; Cortical Cataract; Penetrating KeratoPlasty
• Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert

• Registration Number: NCT04975971
• Lead Sponsor: Nicole Fram M.D.

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

Study Timeline

• Study Start: 2021-03-09
• Primary Completion: 2021-05-19
• Study Completion: 2021-05-19
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study First Posted: 2021-07-26
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Age 18 years and older
• Patients who received DEXTENZA insertion perioperatively.

Exclusion Criteria

• Any patient who did not receive DEXTENZA insertion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dextenza recepient	Dextenza 0.4Mg Ophthalmic Insert	A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in BCVA	Assessed for 3 months after drug insertion	Change in BCVA over post op visits
Resolution of pain	Assessed for 1 months after drug insertion	Resolution of pain as assessed by aquestionnaire in post-op visits
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
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
Adverse events	Assessed for 3 months after drug insertion	Incidence and severity of adverse events
Mean change in IOP	Assessed for 3 months after drug insertion	Mean change in IOP over post-op visits

Trial Locations

Locations (1)

Advanced Vision Care; 🇺🇸 Los Angeles, California, United States