Phase 4
N=18
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
Ptosis, Eyelid
Bottom Line
View on ClinicalTrials.gov: NCT05890027 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Mean MRD1 After Phenylephrine — 2.08 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Phenylephrine Ophthalmic (Drug); Eyelid Tape (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean MRD1 After Phenylephrine |
2.08 | — |
| PRIMARY Mean Change in MRD1 Between Baseline and Phenylephrine |
1.38 | — |
| PRIMARY Mean Superior Visual Field After Taping |
21.40 | — |
| PRIMARY Mean Change in Superior Visual Field After Taping |
14.20 | — |
| PRIMARY Count of Eyes That Met Insurance Criteria After Taping |
27; 5 | — |
| PRIMARY Mean Superior Visual Field After Phenylephrine |
22.27 | — |
| PRIMARY Mean Change in Superior Visual Field After Phenylephrine |
15.07 | — |
| PRIMARY Count of Eyes That Met Insurance Criteria After Phenylephrine |
28; 4 | — |
| SECONDARY Mean Participant Satisfaction Score After Taping |
3.69 | — |
| SECONDARY Mean Participant Satisfaction Score After Phenylephrine |
4.38 | — |
| SECONDARY Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine |
0.69 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05890027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.