Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size
Condition: Cataract
MeSH terms: Cataract
Intervention: Phenylephrine-ketorolac; Epinephrine
Intervention description: Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.; Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
Intervention MeSH terms: Ketorolac; Phenylephrine; Epinephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to compare the maintenance of intraoperative mydriasis during
      cataract surgery between two drugs: epinephrine, which has routinely been used for decades,
      and Omidria, a newly FDA approved combination drug of phenylephrine and ketorolac. Patients
      undergoing cataract surgery that are enrolled in the trial will randomly receive one of the
      drugs in one eye, and the other eye will receive the drug during the subsequent cataract
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are older than 18 years of age

          -  Patients who are planned to undergo bilateral cataract surgery

          -  Patients with baseline IOP of 5 - 22 mm Hg

          -  Medicare insurance*

               -  There is a significant cost difference between our two study drugs. Therefore,
                  Medicare insurance is part of our inclusion criteria, because there is a
                  pass-through reimbursement in place to cover the cost of phenylephrine/ketorolac.
                  Other insurances (for example, Aetna Better Health, Highmark Freedom, Gateway)
                  have variable or poor coverage for phenylephrine/ketorolac, which would leave the
                  medical center responsible for the cost. Patients can never be held responsible
                  for the cost of the medication because it is included in "covered services" for
                  cataract surgery billing.

        Exclusion Criteria:

          -  Patients who are planned to undergo only unilateral cataract surgery

          -  Patients who are planned to undergo cataract surgery and another surgical procedure in
             the same operation (eg. combined cataract and glaucoma surgery)

          -  Patients with concurrent clinically significant disease, connective tissue disease,
             abnormal blood pressure at screening, narrow-angle or unstable glaucoma or treatment
             with prostaglandins, uncontrolled chronic eye disease or active corneal pathology or
             scarring

          -  Patients with history of iritis or trauma with iris damage

          -  Patients with recent eye surgery (non-laser surgery within 3 months or laser surgery
             within 30 days prior to study surgery)

          -  Patients with clinically significant hypersensitivity to the study medications

          -  Patients who have used pilocarpine (a pupil constrictor) within 6 months prior to
             surgery