Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Phase 4

Terminated

• Conditions: Horner Syndrome
• Interventions: Drug: 10% phenylephrine

• Registration Number: NCT03615508
• Lead Sponsor: Denver Health and Hospital Authority

Brief 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.

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 Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Study Start: 2018-09-21
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Results First Submitted: 2020-08-21
• Results First Submitted QC: 2020-09-18
• Results First Posted: 2020-10-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10% phenylephrine	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.

Primary Outcome Measures

Name	Time	Method
Pupil Size Measurements	20-30 minutes after 10% phenylephrine has been placed in each eye.	pupil dilation measurements will be taken of each eye at the eye examination.

Trial Locations

Locations (2)

University of Colorado Hospital, Rocky Mountain Lions Eye Institute; 🇺🇸 Denver, Colorado, United States

Denver Health; 🇺🇸 Denver, Colorado, United States