Kansas City, Missouri 64133

  • Cataract Surgery

Purpose:

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 cataract surgery.


Study summary:

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 + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.


Criteria:

Inclusion Criteria: - Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery. Exclusion Criteria: - 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.


NCT ID:

NCT04316936


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Kansas City, Missouri 64133
United States

Cindy Bentley
Phone: 816-595-3958
Email: cbentley@silversteineyecenters.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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