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Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation

Primary Purpose

Ptosis, Eyelid

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine Ophthalmic
Eyelid Tape
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ptosis, Eyelid

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation. Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution. Individuals who can tolerate eye-drop medications. Individuals who are physically able to take a tangent screen visual field test. Age: Adults who can comprehend the instructions and procedures (18-90 years old). Exclusion Criteria: - This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners. This study will not include participants who refuse to consent. This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects). This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution. Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors

Sites / Locations

  • University of Miami Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phenylephrine and Eye Taping Group

Arm Description

Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes.

Outcomes

Primary Outcome Measures

Change in ptosis as measured by the tangent screen visual field test
Change in ptosis as measured by the tangent screen visual field test in meters
Change in ptosis as measured by the margin to reflex distance 1 (MRD1)
Change in ptosis as measured by the margin to reflex distance 1 (MRD1) in millimeters by transparent ruler

Secondary Outcome Measures

Full Information

First Posted
May 25, 2023
Last Updated
July 18, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05890027
Brief Title
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
Official Title
Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2024 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenylephrine and Eye Taping Group
Arm Type
Experimental
Arm Description
Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine Ophthalmic
Intervention Description
One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.
Intervention Type
Other
Intervention Name(s)
Eyelid Tape
Intervention Description
Participants will have the affected eye with ptosis manually lifted using tape.
Primary Outcome Measure Information:
Title
Change in ptosis as measured by the tangent screen visual field test
Description
Change in ptosis as measured by the tangent screen visual field test in meters
Time Frame
Baseline, 60 minutes
Title
Change in ptosis as measured by the margin to reflex distance 1 (MRD1)
Description
Change in ptosis as measured by the margin to reflex distance 1 (MRD1) in millimeters by transparent ruler
Time Frame
Baseline, 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation. Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution. Individuals who can tolerate eye-drop medications. Individuals who are physically able to take a tangent screen visual field test. Age: Adults who can comprehend the instructions and procedures (18-90 years old). Exclusion Criteria: - This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners. This study will not include participants who refuse to consent. This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects). This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution. Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara T Wester, MD
Phone
(305)-243-2020
Email
SWester2@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara T Wester, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Leveille
Phone
925-389-4200
Email
lal2014@miami.edu
First Name & Middle Initial & Last Name & Degree
Sara T Wester, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation

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