NCT03760185

Pupil Dilation for Treatment of IFIS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraoperative Floppy Iris Syndrome

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate	All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.

Timeline

• Start date: 2019-01-04
• Primary completion: 2020-09-25
• Completion: 2020-09-25
• First posted: 2018-11-30
• Last updated: 2022-04-20
• Results posted: 2022-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study