Pupil Dilation for Treatment of IFIS

Study Overview
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Brief Summary
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A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.

Detailed Description
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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.

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

Conditions
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Intraoperative Floppy Iris Syndrome

Intervention / Treatment
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* Drug: Brimonidine Tartrate


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brimonidine Tartrate 0.2%<br>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<br>* All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.<br>* Other names: Eye Drops;|
| No Intervention: Control - untreated<br>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?
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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 |