Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size

• Status: Terminated
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Epinephrine; Epinephryl borate; Ketorolac; Ketorolac Tromethamine; Oxymetazoline; Phenylephrine; Racepinephrine

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