N/A
Completed N=20
Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes
Assess Phenylephrine on EVP and IOP
Source: ClinicalTrials.gov NCT02965924 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Change in Episcleral Venous Pressure (EVP) — 7.2 mmHg — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Episcleral Venous Pressure (EVP) |
7.2 | <0.01 sig |
| SECONDARY Change in Intraocular Pressure (IOP) |
15.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02965924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.