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

NCT ID: NCT05890027

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-04-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Phenylephrine Ophthalmic

Intervention Type: DRUG

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

Eyelid Tape

Intervention Type: OTHER

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

Interventions

Phenylephrine Ophthalmic

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

Intervention Type: DRUG

Eyelid Tape

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

Intervention Type: OTHER

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+ 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sara T. Wester

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara T Wester, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Bascom Palmer Eye Institute

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20230019

Identifier Type: -

Identifier Source: org_study_id