Cataract Senile Clinical Trial
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
NCT number | NCT04975971 |
Other study ID # | AVC-004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 9, 2021 |
Est. completion date | May 19, 2021 |
Verified date | July 2021 |
Source | Advanced Vision Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 25 |
Est. completion date | May 19, 2021 |
Est. primary completion date | May 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years and older - Patients who received DEXTENZA insertion perioperatively. Exclusion Criteria: - Any patient who did not receive DEXTENZA insertion |
Country | Name | City | State |
---|---|---|---|
United States | Advanced Vision Care | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Nicole Fram M.D. |
United States,
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- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Resolution of pain | Resolution of pain as assessed by aquestionnaire in post-op visits | Assessed for 1 months after drug insertion | |
Secondary | Resolution of anterior chamber inflammation | Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits | Assessed for 3 months after drug insertion | |
Secondary | Proportion of eyes requiring additional post-operative therapy | Proportion of eyes requiring additional post-operative therapy for pain and inflammation | Assessed for 3 months after drug insertion | |
Secondary | Number of patient call-backs regarding post-operative pain | Number of patient call-backs regarding post-operative pain and medication management | Assessed for 3 months after drug insertion | |
Secondary | Number of pharmacy call-backs regarding post-operative medication | Number of pharmacy call-backs regarding post-operative medication management | Assessed for 3 months after drug insertion | |
Secondary | Adverse events | Incidence and severity of adverse events | Assessed for 3 months after drug insertion | |
Secondary | Mean change in IOP | Mean change in IOP over post-op visits | Assessed for 3 months after drug insertion | |
Secondary | Change in BCVA | Change in BCVA over post op visits | Assessed for 3 months after drug insertion |
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