Status:
COMPLETED
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
Lead Sponsor:
Silverstein Eye Centers
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Cataract Surgery
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following catara...
Detailed Description
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenyl...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
Exclusion
- Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04316936
Start Date
December 10 2019
End Date
December 23 2020
Last Update
June 15 2023
Active Locations (1)
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1
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133