Skip to main content
OpenTrials
Completed

NCT Number: NCT05890027

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ptosis, Eyelid Blepharoptosis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine Ophthalmic

Drug

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

Eyelid Tape

Other

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

Primary outcomes

  1. Mean MRD1 After Phenylephrine

    Time frame: 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.

  2. Mean Change in MRD1 Between Baseline and Phenylephrine

    Time frame: 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.

  3. Mean Superior Visual Field After Taping

    Time frame: 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.

  4. Mean Change in Superior Visual Field After Taping

    Time frame: 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.

  5. Count of Eyes That Met Insurance Criteria After Taping

    Time frame: 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.

  6. Mean Superior Visual Field After Phenylephrine

    Time frame: 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.

  7. Mean Change in Superior Visual Field After Phenylephrine

    Time frame: 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.

  8. Count of Eyes That Met Insurance Criteria After Phenylephrine

    Time frame: 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 outcomes

  1. Mean Participant Satisfaction Score After Taping

    Time frame: 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.

  2. Mean Participant Satisfaction Score After Phenylephrine

    Time frame: 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.

  3. Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.