Comparing Phenylephrine and Eyelid Taping for Evaluating Drooping Eyelids
Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
This study tests whether using eye drops or eyelid taping is better for helping doctors decide if adults with drooping eyelids need surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05890027 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Phenylephrine 2.5% ophthalmic eye drops compared to traditional eyelid taping in assessing patients with ptosis who are candidates for surgical repair. Participants will undergo visual field tests to determine the impact of each method on eyelid drooping. The study focuses on adults aged 18 to 90 who can tolerate the eye drops and meet specific inclusion criteria. The goal is to identify which method provides a better indication of the need for surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 diagnosed with ptosis who can tolerate Phenylephrine and undergo visual field testing.
Not a fit: Patients who are unable to consent, under 18, pregnant, or have hypersensitivity to Phenylephrine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the evaluation process for patients with ptosis, leading to better surgical outcomes.
How similar studies have performed: While similar studies have explored various methods for evaluating ptosis, this specific comparison of Phenylephrine and eyelid taping is novel.
Eligibility criteria
Show full inclusion / exclusion 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 (18-90 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
Where this trial is running
Miami, Florida
- University of Miami Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sara T Wester, MD — University of Miami
- Study coordinator: Sara T Wester, MD
- Email: SWester2@med.miami.edu
- Phone: (305)-243-2020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.