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

NCT02895035 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-01-31

Study results available
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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.

Conditions

  • Cataract

Interventions

DRUG

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.

DRUG

Epinephrine

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

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-12-31
Completion
2018-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02895035 on ClinicalTrials.gov