Clinical trial NCT04975971: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Chamber Inflammation
Ocular Pain
Corneal Edema
Corneal Defect
Penetrating KeratoPlasty
Nuclear Cataract
Cortical Cataract
Cataract Senile
Lead sponsor: Advanced Vision Care
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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

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

Primary outcomes:
measure: Mean change in pain score
timeFrame: Assessed for 3 months after drug insertion
measure: Mean change in inflammation (Cell and Flare) scores
timeFrame: Assessed for 3 months after drug insertion
Secondary outcomes:
measure: Resolution of pain
timeFrame: Assessed for 1 months after drug insertion
measure: Resolution of anterior chamber inflammation
timeFrame: Assessed for 3 months after drug insertion
measure: Proportion of eyes requiring additional post-operative therapy
timeFrame: Assessed for 3 months after drug insertion
measure: Number of patient call-backs regarding post-operative pain
timeFrame: Assessed for 3 months after drug insertion
measure: Number of pharmacy call-backs regarding post-operative medication
timeFrame: Assessed for 3 months after drug insertion
measure: Adverse events
timeFrame: Assessed for 3 months after drug insertion
measure: Mean change in IOP
timeFrame: Assessed for 3 months after drug insertion
measure: Change in BCVA
timeFrame: Assessed for 3 months after drug insertion
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
Study officials:
affiliation: Advanced Vision Care
name: Nicole R Fram, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.