Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Control Group Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis |
Drug: 1% preservative-free lidocaine
Instillation of intracameral lidocaine after initial paracentesis incision.
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Experimental: 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 |
Drug: Phenylephrine 1.0%/ Ketorolac 0.3%
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
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Outcome Measures
Primary Outcome Measures
- Visual analog scale to measure pain [Day 1 of operation]
Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation
Eligibility Criteria
Criteria
Inclusion Criteria:
- Individuals with a cataract in the surgical eye
Exclusion Criteria:
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Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
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Those with a past medical history of asthma
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Those systemically using opioids or nonsteroidal anti-inflammatory drugs
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Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
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Those with a history of alpha-1-adrenergic antagonist use
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Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
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Those with a history of iris damage
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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.
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Additionally, individuals less than 21 will be excluded.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Florida
- Omeros Corporation
Investigators
- Principal Investigator: Eric Grieser, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202002831 -A
- OCR40493