Ptosis, Eyelid
Conditions
Brief 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.
Interventions
DRUGPhenylephrine Ophthalmic
One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.
OTHEREyelid Tape
Participants will have the affected eye with ptosis manually lifted using tape.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Eyes That Met Insurance Criteria After Phenylephrine | Baseline, 10 minutes after phenylephrine instillation. | 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. |
| Count of Eyes That Met Insurance Criteria After Taping | Baseline, Within 1 minute after upper eyelid 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. |
| Mean Superior Visual Field After Phenylephrine | 10 minutes after phenylephrine instillation. | 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. |
| Mean Change in Superior Visual Field After Phenylephrine | Baseline, 10 minutes after phenylephrine instillation. | Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees. |
| Mean MRD1 After Phenylephrine | 10 minutes after phenylephrine instillation. | 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. |
| Mean Change in MRD1 Between Baseline and Phenylephrine | Baseline, 10 minutes after phenylephrine instillation. | Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm. |
| Mean Superior Visual Field After Taping | Baseline, Within 1 minute after upper eyelid taping. | Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid. |
| Mean Change in Superior Visual Field After Taping | Baseline, Within 1 minute after upper eyelid taping. | Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Participant Satisfaction Score After Phenylephrine | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. | 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. |
| Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. | 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. |
| Mean Participant Satisfaction Score After Taping | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. | 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. |
Countries
United States
Participant flow
Pre-assignment details
This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. This was a single-arm study in which all recruited eyes progressed sequentially through identical interventions and assessments as described in the Arm/Group Description.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration. | 18 |
| All Study Participants This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration. | 32 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized >18 years old | 18 Participants |
| Baseline MRD1 | 0.69 mm STANDARD_DEVIATION 0.95 |
| Baseline Superior Visual Field | 7.20 degrees STANDARD_DEVIATION 2.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Study Participants | Count of Eyes That Met Insurance Criteria After Phenylephrine | Achieved min 12 degree improvement | 28 eyes |
| All Study Participants | Count of Eyes That Met Insurance Criteria After Phenylephrine | Did not achieve min 12 degree improvement | 4 eyes |
Primary
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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Study Participants | Count of Eyes That Met Insurance Criteria After Taping | Achieved min 12 degree improvement | 27 eyes |
| All Study Participants | Count of Eyes That Met Insurance Criteria After Taping | Did not achieve min 12 degree improvement | 5 eyes |
Primary
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | Mean Change in MRD1 Between Baseline and Phenylephrine | 1.38 mm |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Change in Superior Visual Field After Phenylephrine | 15.07 degrees | Standard Deviation 3.58 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Change in Superior Visual Field After Taping | 14.20 degrees | Standard Deviation 3.53 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean MRD1 After Phenylephrine | 2.08 mm | Standard Deviation 0.91 |
Primary
Mean Superior Visual Field After Phenylephrine
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Superior Visual Field After Phenylephrine | 22.27 degrees | Standard Deviation 3.56 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Superior Visual Field After Taping | 21.40 degrees | Standard Deviation 2.69 |
Secondary
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine | 0.69 score on a scale |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Participant Satisfaction Score After Phenylephrine | 4.38 score on a scale | Standard Deviation 0.79 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Mean Participant Satisfaction Score After Taping | 3.69 score on a scale | Standard Deviation 0.59 |