Status:
COMPLETED
"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"
Lead Sponsor:
The Eye Institute of West Florida
Collaborating Sponsors:
EyePoint Pharmaceuticals, Inc.
Conditions:
Cataract
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antib...
Detailed Description
The current study will assess post cataract the efficacy and safety of two different FDA approved regimens, which include the standard of care (topical steroids, NSAIDs and antibiotics) or Intracamera...
Eligibility Criteria
Inclusion
- • Patients age 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery
Exclusion
- • Patients with history of diabetes mellitus and other systemic conditions that may promote inflammation
- patients with previous ocular disease history
- patients with history of ocular surgery
- patients using prescription eye medications topically
- vulnerable subjects or subjects with diminished capacity requiring a POA (Power of Attorney)
- patients with allergies to steroids, NSAID's, or besifloxacin (standard antibiotic)
- women who are pregnant or lactating
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04781335
Start Date
February 20 2020
End Date
December 22 2022
Last Update
February 25 2025
Active Locations (1)
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1
The Eye Institute of West Florida
Largo, Florida, United States, 33770