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

NCT ID: NCT02895035

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-12-31

Brief 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.

Detailed Description

Cataract remains a leading cause of correctable blindness worldwide. Over 3.5 million cataract surgeries in the United States and 20 million cataract surgeries worldwide are performed every year. Cataract surgery is performed by making a small incision, removing the cataractous lens, most often through the process of phacoemulsification, and replacement with an intraocular lens. Like all surgeries, adequate exposure and field of view is vital for a safe and effective surgery. In cataract surgery, the field of view is limited by the diameter of the pupil. Several different drugs, such as cyclopentolate, tropicamide, phenylephrine, and epinephrine are utilized to maintain dilation (mydriasis) of the pupil during surgery.

There are currently two prospective randomized controlled trials comparing phenylephrine/ketorolac to placebo in the published literature. Both of these studies demonstrated that phenylephrine/ketorolac is superior to placebo for the maintenance of mydriasis during cataract surgery. Epinephrine has been the standard of care for intraoperative mydriasis. Phenylephrine/ketorolac (Omidria) is a newly FDA-approved additive for the maintenance of intraoperative mydriasis, but there are currently no published studies comparing epinephrine to phenylephrine/ketorolac for maintenance of mydriasis during cataract surgery.

While both of these drugs have been shown to be superior to placebo for the maintenance of mydriasis, there is a significant cost difference between epinephrine, which has been used for many years, and phenylephrine/ketorolac, which gained FDA approval in 2014. One 4 mL vial of Omidria® is utilized for one cataract surgery, which costs $465.

The primary endpoint to be measured in the study is the mean area under the curve change from baseline in pupil diameter over time to the end of cataract surgery.

Secondary endpoints will be maximum intraoperative pupil constriction, subjects with pupil diameter less than 6.5 mm at any during surgery, subjects with pupil less than 6.0 mm during cortical clean-up, and subjects with greater than 2.5 mm of pupillary constriction at any time during surgery.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Epinephrine

Epinephrine is the intracameral additive during cataract surgery.

Group Type: ACTIVE_COMPARATOR

Epinephrine

Intervention Type: DRUG

Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.

Omidria

Omidria is the intracameral additive during cataract surgery.

Group Type: ACTIVE_COMPARATOR

Phenylephrine-ketorolac

Intervention Type: DRUG

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.

Interventions

Phenylephrine-ketorolac

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.

Intervention Type: DRUG

Epinephrine

Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.

Intervention Type: DRUG

Other Intervention Names

Omidria

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*

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seth M Pantanelli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00005630

Identifier Type: -

Identifier Source: org_study_id