Pupil Dilation for Treatment of IFIS

Intraoperative Floppy Iris Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760185
• Other study ID #: 18-1713
• Status: Completed
• Phase: Phase 2
• Start date: January 4, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: March 2022
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Floppy Iris Syndrome
• Mydriasis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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