Pupil Dilation for Treatment of IFIS

Phase 2

Completed

• Conditions: Intraoperative Floppy Iris Syndrome
• Interventions: Drug: Brimonidine Tartrate

• Registration Number: NCT03760185
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Study Start: 2019-01-04
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Results First Submitted: 2021-12-10
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Results First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brimonidine Tartrate 0.2%	Brimonidine Tartrate	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.

Primary Outcome Measures

Name	Time	Method
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye	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 Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Denver Health; 🇺🇸 Denver, Colorado, United States