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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Experimental | Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine 2.5% | Drug | Instilling phenylephrine 2.5% eye drop |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur J Sit, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine | Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine | Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | baseline, 60 minutes |
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Adverse Events were collected for 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenylephrine | Subjects will receive topical phenylephrine 2.5% eye drop instilled in one eye after all baseline measurements. Phenylephrine 2.5%: Instilling phenylephrine 2.5% eye drop |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur J. Sit, MD | Mayo Clinic | 507-284-2787 | Sit.Arthur@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2016 | Sep 26, 2019 | Prot_SAP_000.pdf |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | baseline, 60 minutes |
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| 20 |
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| 20 |
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