Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Horner Syndrome Clinical Trial

Official title:

Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03615508
• Other study ID #: COMIRB 18-0620
• Status: Terminated
• Phase: Phase 4
• Start date: September 21, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: February 2022
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Horner Syndrome
• Mydriasis

Intervention

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.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado
United States	University of Colorado Hospital, Rocky Mountain Lions Eye Institute	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.