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Pupil Dilation for Treatment of IFIS

Primary Purpose

Intraoperative Floppy Iris Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brimonidine Tartrate
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Floppy Iris Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Denver Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brimonidine Tartrate 0.2%

Control - untreated

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2018
Last Updated
March 28, 2022
Sponsor
Denver Health and Hospital Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03760185
Brief Title
Pupil Dilation for Treatment of IFIS
Official Title
Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Floppy Iris Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brimonidine Tartrate 0.2%
Arm Type
Experimental
Arm 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.
Arm Title
Control - untreated
Arm Type
No Intervention
Arm Description
The left eye will serve as the control for the study and will not receive the Brimonidine Tartrate 0.2% treatment
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate
Other Intervention Name(s)
"Eye Drops"
Intervention Description
All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
Primary Outcome Measure Information:
Title
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
Description
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
Time Frame
45 minutes post dilation after 7 days of treatment
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
45 minutes post dilation after 7 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristos Ifantides, MD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pupil Dilation for Treatment of IFIS

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