Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
NCT ID: NCT04829799
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2022-02-28
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group
Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis
1% preservative-free lidocaine
Instillation of intracameral lidocaine after initial paracentesis incision.
Study Experimental Group
Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure
Phenylephrine 1.0%/ Ketorolac 0.3%
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
Interventions
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1% preservative-free lidocaine
Instillation of intracameral lidocaine after initial paracentesis incision.
Phenylephrine 1.0%/ Ketorolac 0.3%
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
40 Years
95 Years
ALL
No
Sponsors
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Omeros Corporation
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Eric Grieser, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Other Identifiers
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OCR40493
Identifier Type: OTHER
Identifier Source: secondary_id
IRB202002831 -A
Identifier Type: -
Identifier Source: org_study_id
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