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Clinical Trials/NCT03615508
NCT03615508TerminatedPhase 4

Exploration of Pupil Dilation in Horner's Patients Taking Flomax

Denver Health and Hospital Authority2 sites in 1 country1 target enrollmentStarted: September 21, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
1
Locations
2
Primary Endpoint
Pupil Size Measurements

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Subjects with untreated hypertension
  • Subjects with thyrotoxicosis
  • Pregnant women
  • Inability to consent
  • Subjects with anatomical narrow angles who have never had a dilated exam

Arms & Interventions

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.

Intervention: 10% phenylephrine (Drug)

Outcomes

Primary Outcomes

Pupil Size Measurements

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cristos Ifantides, MD, MBA

Associate Professor, Department of Ophthalmology

Denver Health and Hospital Authority

Study Sites (2)

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