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Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02965924
Recruitment Status : Completed
First Posted : November 17, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Arthur J. Sit, M.D., Mayo Clinic

Brief Summary:
Phenylephrine hydrochloride ophthalmic solution is an alpha-1 adrenergic receptor agonist commonly used topically for dilation prior to ocular fundus examination. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial dilator muscle of the iris. Episcleral venous pressure (EVP) is a determinant of intraocular pressure (IOP) and can be measured non-invasively by venomanometry. Since phenylephrine is a vasoconstrictor, it may affect episcleral venous tone, but the effect on EVP is unknown. Understanding the physiology of episcleral veins helps us in better understanding of pathophysiology of glaucoma.

Condition or disease Intervention/treatment Phase
Assess Phenylephrine on EVP and IOP Drug: Phenylephrine 2.5% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Topical Phenylephrine 2.5% on Episcleral Venous Pressure in Normal Human Eyes
Study Start Date : October 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phenylephrine
Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements.
Drug: Phenylephrine 2.5%
Instilling phenylephrine 2.5% eye drop




Primary Outcome Measures :
  1. Change in Episcleral Venous Pressure (EVP) [ Time Frame: baseline, 60 minutes ]
    EVP will be measured non-invasively using a custom-modified slit-lamp mounted venomanometer. This device utilizes the pressure chamber technique, in which a clear flexible balloon is placed against the conjunctival surface of the eye, and the pressure is increased until an episcleral vein is noted to blanch. The system for pressure-chamber based venomanometry includes a computer-controlled motor drive to increase pressure automatically, a transducer to record pressure, and a high-definition video camera to record vein collapse. Pressure measurements are synchronized with the video stream and image analysis software is used to determine the pressure required to collapse the vein to a specific pre-determined degree as measured in mmHg.


Secondary Outcome Measures :
  1. Change in Intraocular Pressure (IOP) [ Time Frame: baseline, 60 minutes ]
    Intraocular pressure will be measured in mmHg after topical anesthesia by using the pneumatonometer. There will be a minimum of three IOP measurements and a mean will be accepted as IOP.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any self-declared ethno-racial category.
  • Medically healthy subjects.
  • Subjects with two healthy eyes.
  • Intraocular pressure (IOP) less than 22 mmHg in each eye.
  • Best-corrected visual acuity (BCVA) in each eye 20/50 or better.
  • Open angles in both eyes.
  • Contact lens wear stopped at least 3 days prior to study, and during the study.
  • Ability to cooperate for examinations required for study.

Exclusion Criteria:

  • Chronic or acute ophthalmic diseases including glaucoma, wet type macular degeneration, uveitis and clinically significant cataract.
  • Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis.
  • Cornea pathologic changes preventing reliable measurement.
  • Narrow anterior chamber angle.
  • Previous intraocular surgeries, laser procedures, and intravitreal injections.
  • Previous corneal refractive surgeries.
  • Myopia greater than -6.00 D spherical equivalent.
  • Hyperopia greater than +2.00 D spherical equivalent.
  • Lack of suitable episcleral vein for measurement.
  • Ocular trauma within the past 6 months.
  • Ocular infection or ocular inflammation in the past 3 months.
  • Ocular medication of any kind within 30 days of study visit.
  • Known hypersensitivity to Phenylephrine or topical anesthetic medication.
  • Severe hypertension: Systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 105 mmHg.
  • A known history of ischemic heart disease (angina or myocardial infarction), cerebrovascular accidents, cardiac arrhythmias, cerebral or aortic aneurysms.
  • Uncontrolled diabetes mellitus.
  • Uncontrolled hyperthyroidism.
  • Use of some systemic medications within 30 days prior to study including: β-adrenergic antagonists, α-adrenergic agonists and antagonists, calcium channel blockers, diuretics, vasodilators, monoamine oxidase inhibitors, and systemic steroids.
  • Participation in any interventional study within the past 30 days prior to study visit.
  • Women who are pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965924


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Arthur J Sit, M.D. Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Arthur J. Sit, M.D., Mayo Clinic:
Additional Information:
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Responsible Party: Arthur J. Sit, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02965924    
Other Study ID Numbers: 16-007077
First Posted: November 17, 2016    Key Record Dates
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents