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

Ptosis, Eyelid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890027
• Other study ID #: 20230019
• Status: Recruiting
• Phase: Phase 4
• Start date: March 19, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Sara T Wester, MD
• Phone: (305)-243-2020
• Email: SWester2[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Ptosis, Eyelid

Intervention

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

Other:
• Eyelid Tape
Participants will have the affected eye with ptosis manually lifted using tape.

Locations

Country	Name	City	State
United States	University of Miami Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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