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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.
Participants will have the affected eye with ptosis manually lifted using tape.
University of Miami Bascom Palmer Eye Institute
Miami, Florida, United States
Mean MRD1 After Phenylephrine
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.
Time frame: 10 minutes after phenylephrine instillation.
Mean Change in MRD1 Between Baseline and Phenylephrine
Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Mean Superior Visual Field After Taping
Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Mean Change in Superior Visual Field After Taping
Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Count of Eyes That Met Insurance Criteria After 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.
Time frame: Baseline, Within 1 minute after upper eyelid taping.
Mean Superior Visual Field After Phenylephrine
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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.
Time frame: 10 minutes after phenylephrine instillation.
Mean Change in Superior Visual Field After Phenylephrine
Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Count of Eyes That Met Insurance Criteria After Phenylephrine
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.
Time frame: Baseline, 10 minutes after phenylephrine instillation.
Mean Participant Satisfaction Score After Taping
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.
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Participant Satisfaction Score After Phenylephrine
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.
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.
Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine
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.
Time frame: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.