Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

University of Florida

Status and phase: Withdrawn; Phase 4

Conditions: Pain Reduction

Treatments: Drug: 1% preservative-free lidocaine; Drug: Phenylephrine 1.0%/ Ketorolac 0.3%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04829799

OCR40493 (Other Identifier)

IRB202002831 -A

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis

Treatment:

Drug: 1% preservative-free lidocaine

Study Experimental Group

Experimental group

Description:

Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure

Treatment:

Drug: Phenylephrine 1.0%/ Ketorolac 0.3%