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

NCT05890027 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20230019
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ptosis, Eyelid

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Mean Participant Satisfaction Score After Taping

  Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.

• Mean Participant Satisfaction Score After Phenylephrine

  Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.

• Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine

  Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.

Study Arms (1)

Phenylephrine and Eye Taping Group

EXPERIMENTAL

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; Other: Eyelid Tape

Interventions

Phenylephrine Ophthalmic DRUG

One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.

Phenylephrine and Eye Taping Group

Eyelid Tape OTHER

Participants will have the affected eye with ptosis manually lifted using tape.

Phenylephrine and Eye Taping Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Sara T. Wester
• Organization: Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida

swester2@med.miami.edu

(305)-243-2020

Study Officials

• Sara T Wester, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: March 19, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)