Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04829799
Collaborator
Omeros Corporation (Industry)
70
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: 1% preservative-free lidocaine
  • Drug: Phenylephrine 1.0%/ Ketorolac 0.3%
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Florida
  • Omeros Corporation

Investigators

  • Principal Investigator: Eric Grieser, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04829799
Other Study ID Numbers:
  • IRB202002831 -A
First Posted:
Apr 2, 2021
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021