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

NCT02895035 | Terminated Phase 4 Results

• 1 other identifier: 00005630
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Mean Area Under the Curve Change From Baseline in Pupil Diameter Over Time to the End of Cataract Surgery

  Mean area under the curve was calculated by assessing the pupil diameter at baseline and then again at 1 minute intervals until the surgery was complete (max 20 minutes). Units are in millimeters\*seconds

  During cataract surgery, with maximum end time of 20 minutes

Secondary Outcomes (3)

• Maximum Intraoperative Change in Pupil Diameter

  During cataract surgery, with maximum end time of 20 minutes

• Number of Eyes With Pupil Diameter Less Than 6 mm at Any Time During Surgery

  During cataract surgery, with maximum end time of 20 minutes

• Number of Eyes With Pupil Diameter Less Than 6 mm During Cortical Clean-up

  During cataract surgery, cortical clean-up stage, up to 5 mins

Study Arms (2)

Epinephrine

ACTIVE COMPARATOR

Epinephrine is the intracameral additive during cataract surgery.

Drug: Epinephrine

Omidria

ACTIVE COMPARATOR

Omidria is the intracameral additive during cataract surgery.

Drug: Phenylephrine-ketorolac

Interventions

Phenylephrine-ketorolac 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.

Also known as: Omidria

Omidria

Epinephrine DRUG

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

Epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Cataract

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

small sample size some patients received pre-operative topical NSAID in both eyes, while others did not

Results Point of Contact

• Title: Seth Pantanelli
• Organization: Penn State Hershey Eye Center

spantanelli@pennstatehealth.psu.edu

717-531-5690

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 9, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01