Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation
Phase: PHASE4
Conditions: Ptosis, Eyelid
Sponsor: University of Miami

 
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Revised: June 24, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phenylephrine Versus Eyelid Taping for Muller’s Muscle-Conjunctival 
Resection (MMCR) Evaluation 
 
NCT05890027 
 
06/24/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Revised: June 24, 2025 
1) 
Protocol Title 
Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle-
Conjunctival Resection Evaluation 
 
2) 
Objectives 
In this study, we will be assessing whether Phenylephrine 2.5% 
ophthalmic solution eye drops better demonstrate surgical need when 
compared to traditional upper eyelid taping in patients with ptosis under 
evaluation for Muller’s muscle-conjunctival resection.  
 
3) 
Background 
Prior research has quantified the loss of superior visual field (SVF) and 
degree of impairment attributed to ptosis18, 19, 23, 29. Loss of vision due to 
ptosis can lead to difficulty performing activities of daily living, and 
surgical intervention has been demonstrated to significantly improve 
quality of life2, 4, 10, 11, 25. The goal of surgical repair is to improve vision 
by elevating the upper eyelid margin in those with ptosis1. Various 
procedures can be performed to accomplish this including external levator 
resection, Muller’s muscle and conjunctival resection or frontalis 
suspension1,2,5,10. To assess whether the patient’s ptosis is affecting their 
peripheral vision, SVF testing is routinely performed on the ptotic eye first 
at baseline, then after manual taping of the upper eyelid1,6,11,12. Taping 
serves to predict visual improvement after surgical intervention. Baseline 
visual field testing is performed with the eyelid and brow in the resting 
position, and patients must be documented as having a baseline superior 
visual field of 30 degrees or less from fixation. Then, to qualify for 
insurance reimbursement, patients must demonstrate an improvement of at 
least 12 degrees over baseline with eyelid and brow elevation1,6,7, 27, 30.  
 
In a recent study, less than half of patients evaluated with ptosis alone met 
insurance criteria for visual field improvement after eyelid taping as 
compared to those with dermatochalasis or brow ptosis, who met criteria 
in all cases after taping21. This prompted the question of whether manual 
taping accurately mimics surgical outcomes in patients with ptosis only. 
Unlike with dermatochalasis (excess skin) or brow ptosis (drooping 
eyebrow), ptosis (drooping eyelid) requires direct taping of the eyelid 
which can be challenging20. In addition, direct taping of the eyelid can 
lead to difficulty with closing the eyes and subsequent dry eyes, which can 
blur vision. Prior research has demonstrated the difficulties associated 
with manual upper eyelid taping, and alternative taping techniques have 
been proposed20. 
 
This study will evaluate whether Phenylephrine 2.5% ophthalmic solution 
can more accurately measure ptosis severity as compared to manual upper 
eyelid taping in the assessment for and reimbursement of surgical repair. 
Phenylephrine is an alpha-adrenergic agonist and works to elevate the 

 
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Revised: June 24, 2025 
upper eyelid through stimulation and contraction of Mullers muscle3,5, 9, 13, 
17. Phenylephrine eye drops have long been used in patients with ptosis to 
demonstrate surgical need, predict intervention outcomes, and as a tool in 
planning surgical procedures5, 8, 13, 14, 22, 24, 26. In particular, the so-called 
“Phenylephrine Test” has been used by clinicians to assess patient 
eligibility for conjunctival Mullers muscle resections2, 5, 13, 16. To our 
knowledge, this is the first study to directly compare Phenylephrine 
ophthalmic solution to traditional eyelid taping as an effective tool in the 
assessment and reimbursement for surgical ptosis repair.  
 
4) 
Inclusion and Exclusion Criteria 
 
Inclusion:  
- 
Individuals diagnosed with ptosis undergoing conjunctival Muller’s 
muscle resection evaluation. 
- 
Individuals with a baseline MRD1 of less than 2.5.  
- 
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:  
- 
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.  
o Specifically, those with a past medical history of bradycardia, 
hypotension, autonomic dysfunction, or severe cardiovascular 
disease28 
- 
This study will not include individuals who consume drugs 
contraindicated in phenylephrine use: 
o Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates)   
o Iobenguane Radiopharmaceutical Products   
o Kratom  
o Lisuride  
o Monoamine Oxidase Inhibitors 
 
5) 
Procedures Involved 
- 
Study design: 

 
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Revised: June 24, 2025 
o Study Type: Single arm sequential 
o Proposed Enrollment: 30 eyes   
- 
Date range for patient recruitment and data collection:  
o  February 2024 –August 2024 
o Data per eye will be collected in one session lasting up to 60-minutes 
either before or during the patient’s clinical appointment 
- 
Source record:  
o Secure data collection form in Box  
- 
Data collected: 
o Measured values in three conditions (baseline, upper eyelid taped, post-
phenylephrine 2.5% ophthalmic solution):  
 MRD1  
 Tangent screen visual field  
o Patient information: (obtained via participant interview or electronic 
medical record review and recorded in secure Box spreadsheet):  
• Age  
• Visual acuity test results 
• Insurance coverage  
• Do you wear contact lenses? 
• Have you suffered any recent ocular trauma?  
• Have you undergone any recent ocular surgeries? 
• Have you been diagnosed with any cardiovascular 
conditions or undergone any cardiovascular procedures?  
• Have you been diagnosed with a neurologic condition (e.g., 
3rd Cranial Nerve Palsy, Horner Syndrome)?  
• Have you been diagnosed with an autoimmune condition 
(e.g., Myasthenia Gravis)?  
• Has your clinical condition (ptosis) affected your ability to 
complete activities of daily living (e.g., driving, cooking, 
cleaning, dressing)?  
 Post-study questionnaire (obtained once the participant has 
completed all three study conditions and recorded in secure Box 
spreadsheet):  
• On a scale of 1-5 (1 – very poor, 5 – excellent), how was 
your experience with upper eyelid taping?  
o Please elaborate (comments will be recorded) 
• On a scale of 1-5 (1 – very poor, 5 – excellent), how was 
your experience using the Phenylephrine 2.5% eye drops?  
o Please elaborate (comments will be recorded)  
o Outcome Measures: 
 Comparison of efficacy of taped lid and adding phenylephrine 
through Visual Acuity, Measured by using a tangent screen visual 
field test, up to 1 hour. 
 Comparison of efficacy of taped lid and adding phenylephrine 
through MRD 1, Measured by MRD1:distance between upper lid 

 
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Revised: June 24, 2025 
margin and corneal light reflex measured in mm by transparent 
ruler, up to 1 hour. 
- 
Photography: 
o Photographs will be taken prior to testing, with the eyelids taped prior to 
visual field testing, and with phenylephrine eye drops applied prior to 
visual field testing. These photographs are standard of practice when 
submitting documentation to insurance.  
o The participant may decline the publishing of these photographs and still 
be included in the study.  
- 
Patient recruitment and consent: 
o Patients will be recruited from the waiting area and during clinic visits at 
the ophthalmic plastic surgery department at the Bascom Palmer Eye 
Institute. 
o Patients will be given verbal and written information about the study and all 
questions will be answered to ensure comprehension and willingness to 
participate.  
o Patients will sign the physical study consent form prior to the study 
(Appendix II). A copy of this consent form will be provided to the 
participant upon request.  
- 
Research procedure:  
o The researcher will evaluate the MRD1 (Margin to Reflex Distance, 
specifically the distance in millimeters from the light reflex at the center of 
the eye to the center of the upper eyelid), then the participant will undergo 
superior visual field testing using the tangent screen method.  
o These two measures will be evaluated with the ptotic eye in three distinct 
conditions, all patients will be measured in all three conditions, as outlined 
in the following diagram: 
 
 First, MRD1 and superior visual field will be analyzed at baseline 
with no manual taping or eye drops in the ptotic eye.  

 
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 Next, the evaluation will occur with the ptotic upper eyelid 
manually lifted and taped.  
 Lastly, the upper eyelid will be released, and one drop of 
phenylephrine 2.5% ophthalmic solution will be placed in the 
conjunctival fornix of the ptotic eye by the research coordinator as 
the participant looks downward. The analysis will begin 10 
minutes after drop instillation to ensure maximum eyelid 
elevation3.   
 Participants will be provided with breaks in between each of the 
three conditions as needed.  
o The entire study should take no more than 60 minutes. 
 There are numerous tests that can be used to assess visual field 
including Tangent screen, Goldmann perimetry, and Humphrey 
visual field. Tangent screen has been found to be the fastest 
modality of the three. In one study, testing duration of both eyes 
with the eyelids in the natural and taped positions took on average 
12:10 by Goldmann perimetry and 18:50 by Humphry visual field5. 
In contrast, tangent screen testing was found to take an average of 
6:23 to evaluate both eyes in both conditions1.   
o There will be no additional testing or follow-up once the above research 
procedure has been completed.  
6) 
Data and Specimen Banking 
This section is not applicable.  This research is not banking data or specimens for 
future use.  
 
7) 
Data Management 
The data will be collected and stored in Box, a secure and HIPAA-
compliant cloud storage platform. Any paper records will be kept under 
lock and key in the PI’s office. The records kept in the PI’s office will not 
be linked to the patient’s name and will be de-identified according to 
HIPAA requirements. The key that links the study numbers to the patient 
identifiers will be kept separately under lock and key. Only study team 
members, members of the patient’s clinical care team members and people 
in departments or on committees responsible for overseeing the research 
will have access to the data collected.  
 
Statistical procedures will include paired t-test comparing MRD1 values 
between control and phenylephrine, and McNemar’s test to evaluate the 
proportion of eyes that meet insurance criteria between taping and 
phenylephrine. Spearman correlation analysis will be used to assess any 
correlation between changes in MRD1 and VF performance after 
phenylephrine. Additionally, a paired t-test will compare patient 
satisfaction scores after taping and phenylephrine.  
8) 
Risks to Subjects 
- 
Privacy  

 
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o We anticipate that this study will entail minimal psychological/social 
stress related to privacy and confidentiality. Investigators will minimize 
the risk of loss of confidentiality by identifying data collection forms by 
code only, and by only releasing non-identifying information in summary 
format. Personal information will be protected to the fullest extent allowed 
according to federal regulations.  
- 
Adverse Events & Serious Adverse Events   
o An adverse event will be defined as any event that may harm the subject 
or require the subject to seek medical attention, and a serious adverse 
event will be defined as adverse events that require the subject to seek 
medical attention and may be life threatening.   
o Adverse Events  
 Adverse events include falls during or immediately after taking the 
visual field test. Individuals without a fall risk will be chosen for 
the study. In addition, they will be given clear instructions and 
training to prevent falls.   
 This protocol calls for three iterations of tangent screen visual field 
testing which requires focus and can lead to patient fatigue. 
Prolonged, uninterrupted superior visual field testing will be 
avoided, and breaks of 5 minutes will be afforded to the patient 
between tests as needed.  
o Serious Adverse Events   
 A serious fall during or immediately after taking a visual test 
constitutes a serious adverse event. The same precautions as 
mentioned above will be taken to prevent this.   
 Phenylephrine can potentially cause nausea, vomiting, headache, 
and can lead to exacerbations of underlying cardiovascular 
disease28. However, the amount of phenylephrine available 
systemically following ophthalmic application is generally less in 
comparison to oral or IV doses. Additionally, this study will not 
include patients with serious underlying cardiovascular disease. 
 Phenylephrine can also cause blurring of vision impacting 
activities of daily living such as driving15. To minimize risk, study 
team members will set expectations about the testing procedure 
and associated risks (including cautioning against driving or 
operating machinery immediately following dosing) prior to 
testing in the clinic.   
 Risks of Muller's Muscle-Conjunctival Resection may include 
over-exposure of the eye, an asymmetry between eyes, inward or 
outward-turning eyelid, eyelash loss, infection, bleeding, or 
changes in vision.  
 
9) 
Potential Benefits to Subjects 
- 
The study will ultimately provide information for future patients by 
gaining a better understanding of whether phenylephrine 2.5% ophthalmic 

 
Page 8 of 14 
Revised: June 24, 2025 
solution can be used as a more effective criteria for surgical ptosis repair 
evaluation.  
 
10) Vulnerable Populations 
n/a 
 
11) Setting 
Data collection and recruitment will occur at the ophthalmic plastic 
surgery clinic at the Bascom Palmer Eye Institute. Data analysis will take 
place at the University of Miami. 
 
12) Resources Available 
- 
Sara T. Wester, MD – Principal Investigator. Professor of Clinical 
Ophthalmology and specialist in Ophthalmic Plastic and Reconstructive 
Surgery qualified to evaluate visual field quality and outcomes. Dr. Wester 
will be supervising and collaborating with the research team on all aspects 
of this study. 
- 
Naomi Gutkind, MD – Resident physician at the Bascom Palmer Eye 
Institute, qualified to evaluate visual field quality and outcomes. Dr. 
Gutkind will be involved in supervising and collaborating with the 
research team on all aspects of this study. 
- 
Lynn A. Leveille, MS – An MD candidate at the University of Miami 
Miller School of Medicine and registered nurse, Ms. Leveille will be 
involved in the coordination of key research personnel, study design, 
patient consent, data collection, data analysis, interpretation of results, 
data safety and confidentiality, and dissemination of findings.  
- 
Annika J. Patel, BS - An MD candidate at the University of Miami Miller 
School of Medicine, Ms. Patel will be involved in study design, data 
analysis, interpretation of results, data safety, confidentiality, and 
dissemination of findings.  
- 
Chrisfouad R. Alabiad, MD - Professor of Clinical Ophthalmology and 
Assistant Dean for Student Affairs at the University of Miami Miller 
School of Medicine. Dr. Alabiad specializes in Ophthalmic Plastic and 
Reconstructive Surgery at the Bascom Palmer Eye Institute and is 
qualified to evaluate visual field quality and outcomes. Dr. Alabiad will be 
collaborating with the research team on all aspects of this study.  
- 
Wendy W Lee, MD - Professor of Clinical Ophthalmology. Dr. Lee 
specializes in Ophthalmic Plastic and Reconstructive Surgery at the 
Bascom Palmer Eye Institute and is qualified to evaluate visual field 
quality and outcomes. Dr. Lee will be collaborating with the research team 
on all aspects of this study. 
- 
Andrew Rong, MD - Assistant Professor of Clinical Ophthalmology. Dr. 
Rong specializes in Ophthalmic Plastic and Reconstructive Surgery at the 
Bascom Palmer Eye Institute and is qualified to evaluate visual field 
quality and outcomes. Dr. Rong will be collaborating with the research 
team on all aspects of this study. 

 
Page 9 of 14 
Revised: June 24, 2025 
- 
University of Miami Miller School of Medicine (UMMSOM) – 
UMMSOM is a private institution with a mission to perform research that 
will advance the science and practice of medicine. Through this 
commitment to research, UMMSOM is the number one NIH-funded 
institution in Florida.  
- 
Bascom Palmer Eye Institute (BPEI) – BPEI serves as the department of 
ophthalmology for UMMSM. BPEI has consistently been ranked as the 
top eye hospital in the country as published in the U.S. News & World 
Report. 
 
13) Prior Approvals 
No prior approvals were obtained. 
 
14) Recruitment Methods 
Patients who are seen in the ophthalmic plastic surgery clinic at BPEI will 
be asked to participate in this study. Study team members will review 
medical records of patients seen at BPEI from 2/1/2023-2/29/2024 to 
identify eligible participants prior to their next visit. The PI or one of the 
study team members will introduce the study to potential participants. The 
participants will be selected according to the established clinic schedule to 
ensure equal access to study participation. Participants will be recruited at 
the time of their visit to the outpatient clinic. No recruitment 
advertisement or materials will be used. No payments or other incentives 
will be offered to participants.  
 
15) Confidentiality 
Each study participant will be issued a participant ID. All information will  
be stored at UM by participant ID for each participant. All data will be 
stored on the encrypted UM data systems. A shared directory with limited 
access only by those working on the study has been created. Any 
information in paper copy will be kept in a locked file cabinet. Before 
analysis, observations from chart reviews will be stripped of personal 
identifiers and stored indefinitely at the UM for possible future analysis. All 
data will be inspected for quality assurance prior to analysis 
 
All study personnel will be certified to conduct human subjects’ research by the 
University of Miami Institutional Review Board.  
 
Choose the statements below that are applicable to this research:  
 15(a).   ☒  Data will be collected from the EMR or subjects at UHealth or JHS.    
   ☒ Research Subjects will sign a HIPAA Authorization before the research 
will collect this data.  
   ☐ Research Subjects will not sign a HIPAA Authorization for this data 
collection and the research is requesting a waiver of HIPAA authorization 
from the IRB.  (Complete Section 17 below) 
   15(b).  Data collected: 

 
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Revised: June 24, 2025 
  ☐ Will not include Protected Health information or Personally 
Identifiable Information 
☒ Will include Protected Health information or Personally Identifiable 
Information 
    15(c).  How will the research store the data?                 
☐  On a University of Miami electronic device (e.g. encrypted, password-
protected computer) 
☒  On a cloud-based storage system that is approved by the University of Miami 
☐  Other, specify:  Click here to enter text. 
 
Select one of the following:  
☐  The Principal Investigator (and/or Study Team members) will record (e.g. 
write down, abstract) data acquired in a manner that does not include any 
indirect or direct identifiers (listed in the instructions for Section 15 of this 
protocol), and the recorded data will not be linked to the individual’s’ identity.   
   OR 
☒  The Principal investigator (and/or Study Team members) will record (e.g., 
write down, abstract) the data collected in a manner that does not include any 
direct identifiers (see list in the instructions for Section 15 of this protocol) of 
any subject. Instead, the Principal Investigator and/or Study Team members 
will assign a code (that is not derived in whole or in part from any direct or 
indirect identifiers of the individual) to each study subject and link the code 
to the study subject’s identity. The link to each subject’s identity and/ or other 
identifiable information will be maintained on a document separate from the 
research data.  
 
Biospecimens 
☒  Not applicable.  No biospecimens will be collected  
 
15d.  Jackson Health System additional requirement 
  ☒ This section is not applicable because the research is not collecting health 
information from JHS under a waiver of authorization (without obtaining a HIPAA 
authorization from the participant) 
 
16) Provisions to Protect the Privacy Interests of Subjects 
This study will entail minimal psychological/social stress related to privacy 
and confidentiality. Investigators will minimize the risk of loss of 
confidentiality by identifying data collection forms by code only, and by 
only releasing non-identifying information in summary format. Personal 
information will be protected to the fullest extent allowed according to 
federal regulations.    
 

 
Page 11 of 14 
Revised: June 24, 2025 
17) Waiver of Authorization for Use and Disclosure of Protected Health 
Information (HIPAA)  
  ☒ Waiver of Authorization for access to medical record for subject 
identification/recruitment. 
 
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity.  
☒    I confirm  
 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.            
☒     I confirm   
 
18) Consent Process 
All informed consent documents will be in English (with HIPAA authorization 
forms in English, Spanish, and Creole). The consenting process will be conducted 
with the individual in a private room to protect the privacy of the subjects. 
Professional translation services will be utilized as needed. There is no time limit 
for obtaining informed consent. The participants will be given as much time as 
they need to ask questions and come to a decision. Participants are encouraged to 
discuss their involvement with friends and family members prior to signing the 
consent form. The investigator may give the participant a copy of the consent 
form for review before discussing the study at the site. The consent will be 
obtained during a standard care visit. The participant will sign a hard copy of the 
consent form to be saved by the study team. A copy of the consent form will be 
provided to the participant upon request.  
 
All questions will be answered fully before the subject is enrolled into the study, 
however, if questions arise after enrollment the PI's number is listed on the 
consent and the study coordinator will give the participants their information so 
that they may be contacted at any time. Prospective participants will be explained 
that this study is completely voluntary, and they do not have to participate. Their 
medical care will remain the same whether they participate in the study or not. 
The information should be communicated in a manner and language that is clear 
and understandable, be communicated in an organized fashion, and allow for 
questions the subject may have. If the site/investigator is unsure the participant 
understands due to a language or hearing impairment, the participant will not be 
enrolled. 
 
Non-English-Speaking Subjects  
HIPAA authorization forms will be available in English, Spanish, and Creole. 
If/when a subject to be enrolled speaks a language other than English, a translator 
and a witness will be present to orally translate the consent form completely, and 

 
Page 12 of 14 
Revised: June 24, 2025 
they will be provided a written consent in their language of choice, if available, so 
the participant is aware of their rights before they sign, if they chose to do so. If 
an informed consent form or translator is not available in the patient’s desired 
language, the patient will not be enrolled in the study. 
 
Adults Unable to Consent  
Adults unable to consent will be excluded from the proposed study. 
 
19) Process to Document Consent in Writing 
We will obtain informed consent by providing participants with a physical copy 
of the consent documentation, going over the consent details with them and 
having them sign the consent form in person. We will provide a copy of the 
physical consent form upon participant request. The informed consent document 
will also include information regarding who they can call if they have questions 
regarding their participation in the study. 
 
 
 
 
References 
 
1. American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS). 
(2015). Functional Blepharoplasty, Blepharoptosis, and Brow Ptosis Repair 
[White Paper]. American Society of Ophthalmic Plastic and Reconstructive 
Surgery. https://www.asoprs.org/assets/docs/1%20-
%20FINAL%20ASOPRS%20White%20Paper%20January%202015.pdf 
2. Ayala E, Gálvez C, González-Candial M, et al. Predictability of conjunctival-
Müellerectomy for blepharoptosis repair. Orbit 2007;26:21721. 
3. Barsegian A, Botwinick A, Reddy HS. The Phenylephrine Test Revisited. 
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7. Center for Medicare and Medicaid Services (2022). Blepharoplasty, 
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20. Nesher, R., et al. (2007). "A new method for eyelid elevation in glaucoma patients 
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