Phase 2 N=26 Treatment

Pupil Dilation for Treatment of IFIS

Intraoperative Floppy Iris Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03760185 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Apr 2022

Primary outcome: Primary: Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye — 6.76; 7.17 millimeters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Brimonidine Tartrate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Denver Health and Hospital Authority
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye	6.76; 7.17	—
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	0.39; 0.91	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03760185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.