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

University of Miami

Status and phase: Completed; Phase 4

Conditions: Ptosis, Eyelid

Treatments: Drug: Phenylephrine Ophthalmic; Other: Eyelid Tape

Study type: Interventional

Funder types: Other

Identifiers

NCT05890027

20230019

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Phenylephrine and Eye Taping Group

Experimental group

Description:

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.

Treatment:

Other: Eyelid Tape

Drug: Phenylephrine Ophthalmic