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Pupil Dilation for Treatment of IFIS

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ClinicalTrials.gov Identifier: NCT03760185
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Study Description
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Brief Summary:
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.

Condition or disease Intervention/treatment Phase
Intraoperative Floppy Iris Syndrome Drug: Brimonidine Tartrate Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : September 25, 2020
Actual Study Completion Date : September 25, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: All patients
All patients in this arm will receive eye drops to be applied to one eye only. The alternative eye will not receive any eye drops and as such will serve as the control.
 Drug: Brimonidine Tartrate
All subjects will apply brimonidine tartrate to one eye only for the duration of study participation.
Other Name: "Eye Drops"


Outcome Measures
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Primary Outcome Measures :
  1. Pupil Dilation Size of Eye Drop eye compared to nontreated eye [ Time Frame: 30 days ]
    the pupil dilation of the eye in which eye drops were applied to will be measured


Secondary Outcome Measures :
  1. Side Effect Profile [ Time Frame: 30 days ]
    reported side effects of the eye drops will be recorded to elucidate any potential side effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760185


Locations
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United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Cristos Ifantides, MD Denver Health
More Information
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Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT03760185    
Other Study ID Numbers: 18-1713
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Mydriasis
Syndrome
Disease
Pathologic Processes
Pupil Disorders
Eye Diseases
Brimonidine Tartrate
Antihypertensive Agents
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs