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incomplete enrollment
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
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This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.
This study will enroll 10 participants who have a unilateral Horner's Syndrome AND have a history of taking an alpha blocker such as Tamsulosin. Participants will be recruited based on those two enrollment criteria, and after consenting they will undergo pupil dilation with 10% phenylephrine. Once fully dilated the pupil size will be measured. Pupil dilation size of the eye affected by the Horner's Syndrome will be compared to the eye not affected by Horner's. Primary study outcome is the comparative dilation size of the Horner's affected eye to the non affected eye in all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% phenylephrine | Other | All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% phenylephrine | Drug | 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil Size Measurements | pupil dilation measurements will be taken of each eye at the eye examination. | 20-30 minutes after 10% phenylephrine has been placed in each eye. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristos Ifantides, MD | Denver Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital, Rocky Mountain Lions Eye Institute | Denver | Colorado | 80023 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 10% Phenylephrine | All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured. 10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study terminated, no patients analyzed; Data not reported for 1 participant for privacy reasons.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10% Phenylephrine | All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured. 10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Pupil Size Measurements | pupil dilation measurements will be taken of each eye at the eye examination. | Study incomplete. Only 1 subject enrolled and data not reported for 1 participant for privacy reasons. | Posted | 20-30 minutes after 10% phenylephrine has been placed in each eye. |
|
N/A - Adverse Events not Monitored/Assessed
Study not completed.
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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 | 10% Phenylephrine | All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured. 10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ifantides | Denver Health | 303-602-0156 | cristos.ifantides@dhha.org |
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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 | Jul 17, 2020 | Jul 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006732 | Horner Syndrome |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000096826 | Cavernous Sinus Syndromes |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Single arm, intervention trial.
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|
| Denver Health |
| Denver |
| Colorado |
| 80024 |
| United States |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D002493 | Central Nervous System Diseases |
| D015877 | Miosis |
| D011681 | Pupil Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |