Status:
WITHDRAWN
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Omeros Corporation
Conditions:
Pain Reduction
Eligibility:
All Genders
40-95 years
Phase:
PHASE4
Brief Summary
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.
Eligibility Criteria
Inclusion
- Individuals with a cataract in the surgical eye
Exclusion
- Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Those with a past medical history of asthma
- Those systemically using opioids or nonsteroidal anti-inflammatory drugs
- Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
- Those with a history of alpha-1-adrenergic antagonist use
- Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
- Those with a history of iris damage
- Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment.
- Additionally, individuals less than 21 will be excluded.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04829799
Start Date
February 1 2022
End Date
August 1 2023
Last Update
June 13 2022
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