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

Phase 4

Recruiting

• Conditions: Ptosis, Eyelid
• Interventions: Drug: Phenylephrine Ophthalmic; Other: Eyelid Tape

• Registration Number: NCT05890027
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2024-03-19
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phenylephrine and Eye Taping Group	Phenylephrine Ophthalmic	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.
Phenylephrine and Eye Taping Group	Eyelid Tape	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.

Primary Outcome Measures

Name	Time	Method
Change in ptosis as measured by the tangent screen visual field test	Baseline, 60 minutes	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)	Baseline, 60 minutes	Change in ptosis as measured by the margin to reflex distance 1 (MRD1) in millimeters by transparent ruler

Trial Locations

Locations (1)

University of Miami Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States