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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975971
• Other study ID #: AVC-004
• Status: Completed
• Start date: March 9, 2021
• Est. completion date: May 19, 2021

Study information

• Verified date: July 2021
• Source: Advanced Vision Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Any patient who did not receive DEXTENZA insertion

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Advanced Vision Care	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Nicole Fram M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Resolution of pain	Resolution of pain as assessed by aquestionnaire in post-op visits	Assessed for 1 months after drug insertion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Incidence and severity of adverse events	Assessed for 3 months after drug insertion
Secondary	Mean change in IOP	Mean change in IOP over post-op visits	Assessed for 3 months after drug insertion
Secondary	Change in BCVA	Change in BCVA over post op visits	Assessed for 3 months after drug insertion

External Links

•   Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019
•   Efficacy and Safety of Sustained Release Dexamethasone for theTreatment of Ocular Pain and Inflammation after Cataract Surger
•   Recovery after cataract surgery
•   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