Pupil Dilation for Treatment of IFIS

Overview

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

Full Title of Study: “Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 25, 2020

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Brimonidine Tartrate 0.2%
    • One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment.
  • No Intervention: Control – untreated
    • The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. 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:

1. Subjects with untreated hypertension or baseline BP >160 2. Subjects with Thyrotoxicosis 3. Pregnant women or women trying to conceive 4. Prisoners 5. Inability consent 6. Subjects with anatomical narrow angles or who have never had a dilated eye exam 7. Subjects currently prescribed brimonidine tartrate for glaucoma 8. Subjects who take topical or systemic alpha agonists 9. Patients who take monoamine oxidase (MAO) inhibitors 10. Patients with known severe cardiovascular disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Denver Health and Hospital Authority
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cristos Ifantides, MD, Principal Investigator, Denver Health

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