A Retrospective Review of DEXTENZA 0.4 mg inseRt 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 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 Prior to or Following Corneal transplant or Cataract surgery

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • Advanced Vision Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will evaluate n=25 (25 eyes) who underwent corneal transplant or cataract surgery and received DEXTENZA insertion prior to or following surgery as documented in E.H.R

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any patient who did not receive DEXTENZA insertion

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dextenza recepient; 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; 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.; Other Names: Dexamethasone 0.4mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nicole Fram M.D.
• Investigators: Principal Investigator: Nicole R Fram, M.D., Advanced Vision Care

Publications and helpful links

General Publications

• Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. Erratum In: J Cataract Refract Surg. 2019 Jun;45(6):895.

Helpful Links

• DEXTENZA (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019
• Treatment of Post-operative Inflammation following Cataract Surgery - A Review Published Online: May 3rd 2012 European Ophthalmic Review, 2012;6(2):98-103 DOI: http://doi.org/10.17925/EOR.2012.06.02.98
• Recovery after cataract surgery
• Efficacy and Safety of Sustained Release Dexamethasone for theTreatment of Ocular Pain and Inflammation after Cataract Surger

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): May 19, 2021
• Study Completion (Actual): May 19, 2021

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Corneal Diseases; Inflammation; Cataract; Corneal Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: AVC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No