Pupil Dilation for Treatment of IFIS

Denver Health and Hospital Authority13 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraoperative Floppy Iris Syndrome

Interventions

Brimonidine TartrateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Denver Health

Denver, Colorado, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.