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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 2, 2021
First Posted Date July 26, 2021
Last Update Posted Date July 26, 2021
Actual Study Start Date March 9, 2021
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2021)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 14, 2021)
  • Resolution of pain [ Time Frame: Assessed for 1 months after drug insertion ]
    Resolution of pain as assessed by aquestionnaire in post-op visits
  • 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
  • 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
  • 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
  • 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
  • Adverse events [ Time Frame: Assessed for 3 months after drug insertion ]
    Incidence and severity of adverse events
  • Mean change in IOP [ Time Frame: Assessed for 3 months after drug insertion ]
    Mean change in IOP over post-op visits
  • Change in BCVA [ Time Frame: Assessed for 3 months after drug insertion ]
    Change in BCVA over post op visits
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery
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
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
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
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Anterior Chamber Inflammation
  • Ocular Pain
  • Corneal Edema
  • Corneal Defect
  • Penetrating KeratoPlasty
  • Nuclear Cataract
  • Cortical Cataract
  • Cataract Senile
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.
Other Name: Dexamethasone 0.4mg
Study Groups/Cohorts Dextenza recepient
A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery
Intervention: Drug: Dextenza 0.4Mg Ophthalmic Insert
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2021)		 25
Original Actual Enrollment Same as current
Actual Study Completion Date May 19, 2021
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who did not receive DEXTENZA insertion
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04975971
Other Study ID Numbers AVC-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Nicole Fram M.D., Advanced Vision Care
Original Responsible Party Same as current
Current Study Sponsor Nicole Fram M.D.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Nicole R Fram, M.D. Advanced Vision Care
PRS Account Advanced Vision Care
Verification Date July 2021