Pupil Dilation for Treatment of IFIS

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

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

Study Overview

• Status: Completed
• Conditions: Intraoperative Floppy Iris Syndrome
• Intervention / Treatment: Drug: Brimonidine Tartrate

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Brimonidine Tartrate; All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.; Other Names: "Eye Drops"
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye	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	45 minutes post dilation after 7 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	45 minutes post dilation after 7 days of treatment

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Cristos Ifantides, MD, Denver Health

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): September 25, 2020

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Pupil Disorders; Syndrome; Mydriasis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 18-1713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes