Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Pain Reduction Clinical Trial

Official title:

Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04829799
• Other study ID #: IRB202002831 -A
• Secondary ID: OCR40493
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2022
• Est. completion date: August 2023

Study information

• Verified date: June 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Reduction

Intervention

Drug:
• 1% preservative-free lidocaine
Instillation of intracameral lidocaine after initial paracentesis incision.
• Phenylephrine 1.0%/ Ketorolac 0.3%
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Omeros Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale to measure pain	Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation	Day 1 of operation