Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation (NCT05890027) | Clinical Trial Compass
CompletedPhase 4
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
United States18 participantsStarted 2024-03-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Mean MRD1 After Phenylephrine
Timeframe: 10 minutes after phenylephrine instillation.
2
Mean Change in MRD1 Between Baseline and Phenylephrine
Timeframe: Baseline, 10 minutes after phenylephrine instillation.
3
Mean Superior Visual Field After Taping
Timeframe: Baseline, Within 1 minute after upper eyelid taping.
4
Mean Change in Superior Visual Field After Taping
Timeframe: Baseline, Within 1 minute after upper eyelid taping.
5
Count of Eyes That Met Insurance Criteria After Taping
Timeframe: Baseline, Within 1 minute after upper eyelid taping.
6
Mean Superior Visual Field After Phenylephrine
Timeframe: 10 minutes after phenylephrine instillation.
7
Mean Change in Superior Visual Field After Phenylephrine
Timeframe: Baseline, 10 minutes after phenylephrine instillation.
8
Count of Eyes That Met Insurance Criteria After Phenylephrine