Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
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|
Arms and Interventions
|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.
|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.
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
- Individuals with a cataract in the surgical eye
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.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- University of Florida
- Omeros Corporation
- Principal Investigator: Eric Grieser, MD, University of Florida
Study Documents (Full-Text)None provided.
- IRB202002831 -A