Assess Phenylephrine on EVP and IOPNCT02965924
Effect of Topical Phenylephrine 2.5% on EVP in Normal Human Eyes
A study testing Phenylephrine 2.5% in people with Assess Phenylephrine on EVP and IOP, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assess Phenylephrine on EVP and IOP
- What is being tested?
- Phenylephrine 2.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effect of Topical Phenylephrine 2.5% on Episcleral Venous Pressure in Normal Human Eyes
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.
- Conditions
- Assess Phenylephrine on EVP and IOP
- Being tested
- Phenylephrine 2.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine 2.5%Drug
Instilling phenylephrine 2.5% eye drop
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Receives: Drug: Phenylephrine 2.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Episcleral Venous Pressure (EVP)
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.
Measured: baseline, 60 minutes
Secondary outcomes (1)
Change in Intraocular Pressure (IOP)
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.
Measured: baseline, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Assess Phenylephrine on EVP and IOPStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur J. Sit, M.D., Mayo Clinic
- Investigators
- Arthur J Sit, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965924
- Sponsor's protocol ID
- 16-007077
- Status last verified
- Oct 2019
- First submitted
- 15 Nov 2016
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Phenylephrine 2.5% on Episcleral Venous Pressure in Normal Human Eyes
- ClinicalTrials.gov ID
- NCT02965924
- Acronym / sponsor ID
- 16-007077
- Conditions
- Assess Phenylephrine on EVP and IOP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: Phenylephrine 2.5%Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine 2.5%Instilling phenylephrine 2.5% eye drop | Drug | Phenylephrine |
Primary outcome
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.
1 secondary outcome
Change in Intraocular Pressure (IOP)
Time frame: baseline, 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur J Sit, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine 2.5% in people with Assess Phenylephrine on EVP and IOP, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Episcleral Venous Pressure (EVP) (time frame: baseline, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.