Pupil Dilation for Treatment of IFIS

NCT ID: NCT03760185

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2020-09-25

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.

Conditions

Intraoperative Floppy Iris Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brimonidine Tartrate 0.2%

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.

Group Type: EXPERIMENTAL

Brimonidine Tartrate

Intervention Type: DRUG

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

Control - untreated

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brimonidine Tartrate

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

Intervention Type: DRUG

Other Intervention Names

"Eye Drops"

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristos Ifantides, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Locations

Denver Health

Denver, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

18-1713

Identifier Type: -

Identifier Source: org_study_id