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Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615508
Enrollment
1
Registered
2018-08-03
Start date
2018-09-21
Completion date
2019-05-01
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horner Syndrome

Keywords

Alpha blockers, Tamsulosin

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.

Interventions

DRUG10% 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.

Sponsors

University of Colorado, Denver
CollaboratorOTHER
Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single arm, intervention trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pupil Size Measurements20-30 minutes after 10% phenylephrine has been placed in each eye.pupil dilation measurements will be taken of each eye at the eye examination.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
0
Total0

Baseline characteristics

Characteristic
Region of Enrollment
United States
— participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Pupil Size Measurements

pupil dilation measurements will be taken of each eye at the eye examination.

Time frame: 20-30 minutes after 10% phenylephrine has been placed in each eye.

Population: Study incomplete. Only 1 subject enrolled and data not reported for 1 participant for privacy reasons.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026