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

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ClinicalTrials.gov Identifier: NCT04975971
Recruitment Status : Completed
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Nicole Fram M.D., Advanced Vision Care

Study Description
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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

Condition or disease Intervention/treatment
Anterior Chamber Inflammation Ocular Pain Corneal Edema Corneal Defect Penetrating KeratoPlasty Nuclear Cataract Cortical Cataract Cataract Senile 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 Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : March 9, 2021
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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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 Name: Dexamethasone 0.4mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who did not receive DEXTENZA insertion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975971


Locations
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United States, California
Advanced Vision Care
Los Angeles, California, United States, 90067
Sponsors and Collaborators
Nicole Fram M.D.
Investigators
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Principal Investigator: Nicole R Fram, M.D. Advanced Vision Care
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Nicole Fram M.D., Principal Investigator, Advanced Vision Care
ClinicalTrials.gov Identifier: NCT04975971    
Other Study ID Numbers: AVC-004
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Corneal Edema
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Corneal Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents