Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Omeros Corporation
• Treatments: Ketorolac; Lidocaine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Individuals with a cataract in the surgical eye

Exclusion Criteria:

• 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.