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

Phase 4

Completed

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

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
Mean MRD1 After Phenylephrine	10 minutes after phenylephrine instillation.	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.
Mean Change in Superior Visual Field After Taping	Baseline, Within 1 minute after upper eyelid taping.	Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.
Mean Change in MRD1 Between Baseline and Phenylephrine	Baseline, 10 minutes after phenylephrine instillation.	Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.
Mean Superior Visual Field After Taping	Baseline, Within 1 minute after upper eyelid taping.	Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.
Count of Eyes That Met Insurance Criteria After Taping	Baseline, Within 1 minute after upper eyelid 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.
Mean Superior Visual Field After Phenylephrine	10 minutes after phenylephrine instillation.	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.
Mean Change in Superior Visual Field After Phenylephrine	Baseline, 10 minutes after phenylephrine instillation.	Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.
Count of Eyes That Met Insurance Criteria After Phenylephrine	Baseline, 10 minutes after phenylephrine instillation.	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.

Secondary Outcome Measures

Name	Time	Method
Mean Participant Satisfaction Score After Taping	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.
Mean Participant Satisfaction Score After Phenylephrine	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.
Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine	Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.	After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.

Trial Locations

Locations (1): University of Miami Bascom Palmer Eye Institute
🇺🇸
Miami, Florida, United States
University of Miami Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States