Pupil Dilation for Treatment of IFIS

Denver Health and Hospital Authority

Status and phase: Completed; Phase 2

Conditions: Intraoperative Floppy Iris Syndrome

Treatments: Drug: Brimonidine Tartrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03760185

18-1713

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Brimonidine Tartrate 0.2%

Experimental group

Description:

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.

Treatment:

Drug: Brimonidine Tartrate

Control - untreated

No Intervention group

Description:

The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment