Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Phase 4

Withdrawn

• Conditions: Pain Reduction
• Interventions: Drug: Phenylephrine 1.0%/ Ketorolac 0.3%; Drug: 1% preservative-free lidocaine

• Registration Number: NCT04829799
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2022-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Experimental Group	Phenylephrine 1.0%/ Ketorolac 0.3%	Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure
Control Group	1% preservative-free lidocaine	Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis

Primary Outcome Measures

Name	Time	Method
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