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Completed

NCT Number: NCT04975971

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

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Key information

Conditions

Anterior Chamber Inflammation Cataract Senile Corneal Defect Corneal Diseases Corneal Edema Cortical Cataract Eye Diseases Eye Manifestations Eye Pain Neurologic Manifestations Nuclear Cataract Ocular Pain Pain Pathological Conditions, Signs and Symptoms Penetrating Keratoplasty Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Vision Care

Los Angeles, California, 90067, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any patient who did not receive DEXTENZA insertion

Treatment and study plan

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.

Other names: Dexamethasone 0.4mg

Primary outcomes

  1. Mean change in pain score

    Time frame: 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

  2. Mean change in inflammation (Cell and Flare) scores

    Time frame: 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 outcomes

  1. Resolution of pain

    Time frame: Assessed for 1 months after drug insertion

    Resolution of pain as assessed by aquestionnaire in post-op visits

  2. Resolution of anterior chamber inflammation

    Time frame: Assessed for 3 months after drug insertion

    Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits

  3. Proportion of eyes requiring additional post-operative therapy

    Time frame: Assessed for 3 months after drug insertion

    Proportion of eyes requiring additional post-operative therapy for pain and inflammation

  4. Number of patient call-backs regarding post-operative pain

    Time frame: Assessed for 3 months after drug insertion

    Number of patient call-backs regarding post-operative pain and medication management

  5. Number of pharmacy call-backs regarding post-operative medication

    Time frame: Assessed for 3 months after drug insertion

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

  6. Adverse events

    Time frame: Assessed for 3 months after drug insertion

    Incidence and severity of adverse events

  7. Mean change in IOP

    Time frame: Assessed for 3 months after drug insertion

    Mean change in IOP over post-op visits

  8. Change in BCVA

    Time frame: Assessed for 3 months after drug insertion

    Change in BCVA over post op visits

Sponsors and collaborators

Lead sponsor

Nicole Fram M.D.

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2021
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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