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OpenTrials
Completed

NCT Number: NCT03760185

Pupil Dilation for Treatment of IFIS

A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.

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Key information

Conditions

Intraoperative Floppy Iris Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Denver Health

Denver, Colorado, 80204, United States

About this study

This study explores the effects that medication can have on increasing pupil dilation. Pupil dilation size is important for operative eye procedures. Decreased pupil size is related to increased complication risks in eye surgery. By exploring novel pupil dilation techniques, there is a potential to counteract the effects of poor pupil dilation that is caused by medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused by BPH medications. This study evaluates treatment methods targeting IFIS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days

Exclusion criteria

  • Subjects with untreated hypertension or baseline BP >160
  • Subjects with Thyrotoxicosis
  • Pregnant women or women trying to conceive
  • Prisoners
  • Inability consent
  • Subjects with anatomical narrow angles or who have never had a dilated eye exam
  • Subjects currently prescribed brimonidine tartrate for glaucoma
  • Subjects who take topical or systemic alpha agonists
  • Patients who take monoamine oxidase (MAO) inhibitors
  • Patients with known severe cardiovascular disease

Treatment and study plan

Brimonidine Tartrate

Drug

All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.

Other names: "Eye Drops"

Primary outcomes

  1. Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye

    Time frame: 45 minutes post dilation after 7 days of treatment

    The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye

Secondary outcomes

  1. Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study

    Time frame: 45 minutes post dilation after 7 days of treatment

    Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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