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

Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Ptosis, Eyelid
• Intervention / Treatment: Drug: Phenylephrine Ophthalmic; Other: Eyelid Tape

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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+ 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenylephrine and Eye Taping Group; 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.	Drug: Phenylephrine Ophthalmic; One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.; Other: Eyelid Tape; Participants will have the affected eye with ptosis manually lifted using tape.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean MRD1 After Phenylephrine	Margin to Reflex Distance 1 measured at least ten minutes after administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye. Measured in mm.	10 minutes after phenylephrine instillation.
Mean Change in MRD1 Between Baseline and Phenylephrine	Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.	Baseline, 10 minutes after phenylephrine instillation.
Mean Superior Visual Field After Taping	Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.	Baseline, Within 1 minute after upper eyelid taping.
Mean Change in Superior Visual Field After Taping	Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.	Baseline, Within 1 minute after upper eyelid taping.
Count of Eyes That Met Insurance Criteria After Taping	Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline). Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and taping of the upper eyelid.	Baseline, Within 1 minute after upper eyelid taping.
Mean Superior Visual Field After Phenylephrine	Degree of ptosis as measured by a tangent screen superior visual field test ten minutes after the administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye.	10 minutes after phenylephrine instillation.
Mean Change in Superior Visual Field After Phenylephrine	Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.	Baseline, 10 minutes after phenylephrine instillation.
Count of Eyes That Met Insurance Criteria After Phenylephrine	Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline). Here we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and phenylephrine ophthalmic solution instillation.	Baseline, 10 minutes after phenylephrine instillation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Participant Satisfaction Score After Taping	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Participant Satisfaction Score After Phenylephrine	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Sara T Wester, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Cardiotonic Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Oxymetazoline; Phenylephrine
• Other Study ID Numbers: 20230019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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