Exploration of Pupil Dilation in Horner's Patients Taking Flomax

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.

Study Overview

• Status: Terminated
• Conditions: Horner Syndrome
• Intervention / Treatment: Drug: 10% phenylephrine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80023
      • University of Colorado Hospital, Rocky Mountain Lions Eye Institute
    • Denver, Colorado, United States, 80024
      • Denver Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Horner's Syndrome
2. History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication

Exclusion Criteria:

1. Subjects with untreated hypertension
2. Subjects with thyrotoxicosis
3. Pregnant women
4. Prisoners
5. Inability to consent
6. Subjects with anatomical narrow angles who have never had a dilated exam

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: 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.; Other Names: Phenylephrine 10%, Pupil Dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Cristos Ifantides, MD, Denver Health

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Tamsulosin; Alpha blockers
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Autonomic Nervous System Diseases; Miosis; Pupil Disorders; Horner Syndrome; Mydriasis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: COMIRB 18-0620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes