Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine and Eye Taping Group | Experimental | Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine Ophthalmic | Drug | One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Baseline, Within 1 minute after upper eyelid taping. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sara T Wester, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42024579 | Derived | Kaur M, Leveille LA, Alabiad CR, Rong AJ, Wester ST. Preoperative Ptosis Evaluation: A Comparative Analysis of Phenylephrine Drops and Eyelid Taping for Visual Field Testing. Ophthalmic Plast Reconstr Surg. 2026 Apr 23. doi: 10.1097/IOP.0000000000003204. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 in a single arm, sequential design as outlined below. Study Protocol: Each eye with ptosis underwent the following sequential interventions and assessments:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm | 10 minutes after phenylephrine instillation. | eyes | eyes |
|
1 year
This eye-based study treated each ptotic eye as an individual unit. Bilateral ptosis participants contributed two eyes; unilateral ptosis participants contributed one eye. All eyes underwent identical sequential interventions and assessments in this single-arm study. Since all participants received the same intervention sequence, adverse events are reported under one arm: "all study participants."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
All recruited eyes progressed through all testing conditions (baseline, taping, and phenylephrine ophthalmic solution). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara T. Wester | Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida | (305)-243-2020 | swester2@med.miami.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2025 | Jun 25, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Eyelid Tape | Other | Participants will have the affected eye with ptosis manually lifted using tape. |
|
| 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. | 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. | 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. | Baseline, 10 minutes 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. | 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. | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. |
| eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Baseline MRD1 | Mean | Standard Deviation | mm | eyes |
|
| Baseline Superior Visual Field | Mean | Standard Deviation | degrees | 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. | Posted | Mean | 95% Confidence Interval | mm | Baseline, 10 minutes after phenylephrine instillation. | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | Baseline, Within 1 minute after upper eyelid taping. | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | Baseline, Within 1 minute after upper eyelid taping. | eyes | 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. | Posted | Count of Units | eyes | Baseline, Within 1 minute after upper eyelid taping. | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | 10 minutes after phenylephrine instillation. | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | Baseline, 10 minutes after phenylephrine instillation. | eyes | eyes |
|
|
|
| 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. | Posted | Count of Units | eyes | Baseline, 10 minutes after phenylephrine instillation. | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation. |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
Not provided
Not provided