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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ptosis, Eyelid

Intervention / Treatment
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* Drug: Phenylephrine Ophthalmic
* Other: Eyelid Tape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 60 minutes | 
| 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 | Baseline, 60 minutes |