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

NCT04975971 | Completed FDA Drug

• 1 other identifier: AVC-004
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Resolution of pain

  Assessed for 1 months after drug insertion

• Resolution of anterior chamber inflammation

  Assessed for 3 months after drug insertion

• Proportion of eyes requiring additional post-operative therapy

  Assessed for 3 months after drug insertion

• Number of patient call-backs regarding post-operative pain

  Assessed for 3 months after drug insertion

• Number of pharmacy call-backs regarding post-operative medication

  Assessed for 3 months after drug insertion

Study Arms (1)

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

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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.

Also known as: Dexamethasone 0.4mg

Dextenza recepient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Any patient who did not receive DEXTENZA insertion

Sponsors & Collaborators

• Nicole Fram M.D.: lead

Study Sites (1)

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Related 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-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.

  PMID: 30367938 RESULT

Related Links

• Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019

MeSH Terms

Conditions

Eye Pain; Corneal Edema

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Corneal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nicole R Fram, M.D.

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 26, 2021
• Study Start: March 9, 2021
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)