Pain Reduction
Conditions
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.
Interventions
DRUG1% preservative-free lidocaine
Instillation of intracameral lidocaine after initial paracentesis incision.
DRUGPhenylephrine 1.0%/ Ketorolac 0.3%
Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
Sponsors
Omeros Corporation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed